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Sample records for acne drug products

  1. 21 CFR 333.350 - Labeling of acne drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips... this section. (ii) The labeling states “ if going outside, apply sunscreen after using this product....

  2. 21 CFR 333.350 - Labeling of acne drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips... this section. (ii) The labeling states “ if going outside, apply sunscreen after using this product....

  3. 21 CFR 333.350 - Labeling of acne drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips... this section. (ii) The labeling states “ if going outside, apply sunscreen after using this product....

  4. 21 CFR 333.350 - Labeling of acne drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips... this section. (ii) The labeling states “ if going outside, apply sunscreen after using this product....

  5. 21 CFR 333.350 - Labeling of acne drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips... this section. (ii) The labeling states “ if going outside, apply sunscreen after using this product....

  6. Classification of benzoyl peroxide as safe and effective and revision of labeling to drug facts format; topical acne drug products for over-the-counter human use; final rule.

    PubMed

    2010-03-01

    We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products. PMID:20383916

  7. FDA OKs Non-Prescription Use of Acne Drug

    MedlinePlus

    ... 159779.html FDA OKs Non-Prescription Use of Acne Drug Differin Gel 0.1% is first retinoid ... July 8, 2016 (HealthDay News) -- Good news for acne sufferers: The U.S. Food and Drug Administration has ...

  8. Acne

    MedlinePlus

    ... can try different ones to see which helps. Products with benzoyl peroxide (say: BEN-zoil peh - ROK - side) or salicylic (say: sal-uh-SIL - ick) acid in them are usually pretty helpful for treating acne. Benzoyl peroxide kills the bacteria that can lead to acne and it also ...

  9. Acne

    MedlinePlus

    ... Home Body Looking and feeling your best Acne Acne Whether you call them pimples, zits, or acne, ... treatments? What doesn’t cause acne? What causes acne? top Acne happens when your pores get clogged ...

  10. Acne

    MedlinePlus

    ... a prescription. A product containing benzoyl peroxide or salicylic acid often clears the skin. This does not mean ... retinoid, prescription-strength benzoyl peroxide, antibiotic, or even salicylic acid. Your dermatologist will determine what you need. Acne ...

  11. Acne

    MedlinePlus

    ... products may contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid. They work by killing bacteria, drying up skin ... Prescription formulas of benzoyl peroxide, sulfur, resorcinol, or salicylic acid Topical azelaic acid For women whose acne is ...

  12. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... applicable to all OTC topical acne products marketed under the monograph (75 FR 9767, March 4, 2010) (final rule). The guidance describes the requirements of the final rule in plain language and provides...

  13. Acne

    MedlinePlus

    MENU Return to Web version Acne Overview What is acne? Acne is a skin problem that occurs when the hair follicles of your skin are blocked by ... plugged hair follicles and cause more skin irritation. Acne can occur anywhere on skin, but is most ...

  14. Acne

    MedlinePlus

    Acne is a common skin disease that causes pimples. Pimples form when hair follicles under your skin ... neck, back, chest, and shoulders. Anyone can get acne, but it is common in teenagers and young ...

  15. Carrier-Based Drug Delivery System for Treatment of Acne

    PubMed Central

    Vyas, Amber; Kumar Sonker, Avinesh

    2014-01-01

    Approximately 95% of the population suffers at some point in their lifetime from acne vulgaris. Acne is a multifactorial disease of the pilosebaceous unit. This inflammatory skin disorder is most common in adolescents but also affects neonates, prepubescent children, and adults. Topical conventional systems are associated with various side effects. Novel drug delivery systems have been used to reduce the side effect of drugs commonly used in the topical treatment of acne. Topical treatment of acne with active pharmaceutical ingredients (API) makes direct contact with the target site before entering the systemic circulation which reduces the systemic side effect of the parenteral or oral administration of drug. The objective of the present review is to discuss the conventional delivery systems available for acne, their drawbacks, and limitations. The advantages, disadvantages, and outcome of using various carrier-based delivery systems like liposomes, niosomes, solid lipid nanoparticles, and so forth, are explained. This paper emphasizes approaches to overcome the drawbacks and limitations associated with the conventional system and the advances and application that are poised to further enhance the efficacy of topical acne formulations, offering the possibility of simplified dosing regimen that may improve treatment outcomes using novel delivery system. PMID:24688376

  16. Acne and systemic disease.

    PubMed

    Lolis, Margarita S; Bowe, Whitney P; Shalita, Alan R

    2009-11-01

    Acne is the most common disease of the skin. It affects 85% of teenagers, 42.5% of men, and 50.9% of women between the ages of 20 and 30 years.96,97 The role of hormones, particularly as a trigger of sebum production and sebaceous growth and differentiation, is well known. Excess production of hormones, specifically androgens, GH, IGF-1, insulin, CRH, and glucocorticoids, is associated with increased rates of acne development. Acne may be a feature in many endocrine disorders, including polycystic ovary disease, Cushing syndrome, CAH, androgen-secreting tumors, and acromegaly. Other nonendocrine diseases associated with acne include Apert syndrome, SAPHO syndrome, Behçet syndrome and PAPA syndrome. Acne medicamentosa is the development of acne vulgaris or an acneiform eruption with the use of certain medications. These medications include testosterone, progesterone,steroids, lithium, phenytoin, isoniazid, vitamins B2, B6, and B12, halogens, and epidermal growth factor inhibitors. Management of acne medicamentosa includes standard acne therapy. Discontinuation of the offending drug may be necessary in recalcitrant cases. Basic therapeutic interventions for acne include topical therapy, systemic antibiotics,hormonal agents, isotretinoin, and physical treatments. Generally, the severity of acne lesions determines the type of acne regimen necessary. The emergence of drug-resistant P acnes and adverse side effects are current limitations to effective acne management. PMID:19932324

  17. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations.

    PubMed

    Johnson, Tremylla; Kang, Dezhi; Barnard, Emma; Li, Huiying

    2016-01-01

    causal role in several diseases including acne, a common skin disease affecting more than 80% of people worldwide. While specific strains of P. acnes have been associated with either disease or healthy skin, the mechanisms remain unclear. Recently, we showed that vitamin B12 supplementation increased porphyrin production in P. acnes, leading to acne development (D. Kang, B. Shi, M. C. Erfe, N. Craft, and H. Li, Sci. Transl. Med. 7:293ra103, 2015, doi:10.1126/scitranslmed.aab2009). Here, we reveal that the levels of porphyrin production and vitamin B12 regulation are different between acne- and health-associated strains, suggesting a potential molecular mechanism for disease-associated strains in acne pathogenesis and for health-associated strains in skin health. This study highlights the importance of understanding the strain-level differences of the human microbiota in disease pathogenesis. Our findings also suggest the porphyrin biosynthesis pathway as a candidate drug target and use of health-associated strains as potential probiotics in novel acne therapeutics. PMID:27303708

  18. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations

    PubMed Central

    Johnson, Tremylla; Kang, Dezhi; Barnard, Emma

    2016-01-01

    to play a causal role in several diseases including acne, a common skin disease affecting more than 80% of people worldwide. While specific strains of P. acnes have been associated with either disease or healthy skin, the mechanisms remain unclear. Recently, we showed that vitamin B12 supplementation increased porphyrin production in P. acnes, leading to acne development (D. Kang, B. Shi, M. C. Erfe, N. Craft, and H. Li, Sci. Transl. Med. 7:293ra103, 2015, doi:10.1126/scitranslmed.aab2009). Here, we reveal that the levels of porphyrin production and vitamin B12 regulation are different between acne- and health-associated strains, suggesting a potential molecular mechanism for disease-associated strains in acne pathogenesis and for health-associated strains in skin health. This study highlights the importance of understanding the strain-level differences of the human microbiota in disease pathogenesis. Our findings also suggest the porphyrin biosynthesis pathway as a candidate drug target and use of health-associated strains as potential probiotics in novel acne therapeutics. PMID:27303708

  19. Acne

    PubMed Central

    Whiting, David A.

    1979-01-01

    The cause of acne is still obscure, but genetic predisposition, sebaceous overactivity, overgrowth of bacterial flora and exposure to comedogenic substances are all significant factors. Acne lesions occur mainly in sebaceous follicles, which are characterized by deep follicular canals and large sebaceous glands. The associated seborrhea is not due to a circulatory excess of androgens but may be caused by a local amplification of androgenic activity. This, in turn, may be due to large numbers of androgen receptors and a high concentration of enzymes such as 17β-hydroxysteroid dehydrogenase, within the sebaceous gland itself. Hyperkeratosis of the retention type in the pilary infrainfundibulum obstructs the outflow of sebum and keratin flakes. This favors the proliferation of Propionibacterium acnes which may initiate inflammation in microcomedos and lead to formation of pustules, papules or nodules. Topical therapy with tretinoin, benzoyl peroxide and antibiotics such as clindamycin is widely used today. Oral tetracyclines and other chemotherapeutic agents remain necessary in severe cases. PMID:161830

  20. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  1. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  2. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  3. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  4. 21 CFR 333.310 - Acne active ingredients.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Acne active ingredients. 333.310 Section 333.310... FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Topical Acne Drug Products § 333.310 Acne active ingredients. The active ingredient of the product consists of any of...

  5. [Acne tarda. Acne in adults].

    PubMed

    Jansen, T; Janßen, O E; Plewig, G

    2013-04-01

    Acne is one of the most common skin diseases in the general population, especially among adolescents. Acne tarda (adult acne) is defined as acne that develops (late-onset acne) or continues (persistent acne) after 25 years of age. The disease is more common in women. The clinical features are quite specific: inflammatory acne in the lower facial region or macrocomedones (microcysts) spread over the face. Involvement of the trunk is much more common in men. The etiology of acne tarda is still controversial, as cosmetics, drugs, smoking, stress, diet, and endocrine abnormalities have been implicated. Women with acne tarda and other symptoms of hyperandrogenism have a high probability of endocrine abnormalities such as polycystic ovary syndrome. Treatment is similar to that of acne in adolescence. Long-term treatment over years or decades may be required. PMID:23576169

  6. Topical retinoids for acne.

    PubMed

    Yeh, Lindsey; Bonati, Lauren Meshkov; Silverberg, Nanette B

    2016-06-01

    Topical retinoids are currently approved by the US Food and Drug Administration for the treatment of acne vulgaris in nonpregnant, nonlactating patients 12 years of age and older. Their efficacy, safety, and tolerability are well documented for inflammatory and noninflammatory acne with studies repeatedly demonstrating a decrease in the number of lesions, significant improvement in acne severity, improvement in the cosmetic appearance of acne, and the prevention of acne lesions through microcomedone formation. There is some variability between prescription retinoid products regarding efficacy, safety, and tolerability; with erythema, peeling, and dryness being common, potential side effects. Due to their efficacious and safe profile, topical retinoids remain the first-line treatment for acne vulgaris. PMID:27416308

  7. Acne

    MedlinePlus

    ... your skin. These products may contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid. They work by killing ... tretinoin, Retin-A) Prescription formulas of benzoyl peroxide, sulfur, resorcinol, or salicylic acid Topical azelaic acid For ...

  8. Acne vulgaris.

    PubMed

    Williams, Hywel C; Dellavalle, Robert P; Garner, Sarah

    2012-01-28

    Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinisation, inflammation, and bacterial colonisation of hair follicles on the face, neck, chest, and back by Propionibacterium acnes. Although early colonisation with P acnes and family history might have important roles in the disease, exactly what triggers acne and how treatment affects the course of the disease remain unclear. Other factors such as diet have been implicated, but not proven. Facial scarring due to acne affects up to 20% of teenagers. Acne can persist into adulthood, with detrimental effects on self-esteem. There is no ideal treatment for acne, although a suitable regimen for reducing lesions can be found for most patients. Good quality evidence on comparative effectiveness of common topical and systemic acne therapies is scarce. Topical therapies including benzoyl peroxide, retinoids, and antibiotics when used in combination usually improve control of mild to moderate acne. Treatment with combined oral contraceptives can help women with acne. Patients with more severe inflammatory acne usually need oral antibiotics combined with topical benzoyl peroxide to decrease antibiotic-resistant organisms. Oral isotretinoin is the most effective therapy and is used early in severe disease, although its use is limited by teratogenicity and other side-effects. Availability, adverse effects, and cost, limit the use of photodynamic therapy. New research is needed into the therapeutic comparative effectiveness and safety of the many products available, and to better understand the natural history, subtypes, and triggers of acne. PMID:21880356

  9. The In vitro anti-acne activity of two unani drugs

    PubMed Central

    Chaudhary, Shahid Shah; Tariq, Mohd.; Zaman, Roohi; Imtiyaz, Shaikh

    2013-01-01

    Background: Acne is the most common disorder treated by dermatologists. As many as 80-90% of all adolescents have some type of acne and 30% of them require medical treatment. It is an inflammatory disease of the pilosebaceous unit characterized by the formation of open and closed comedones, papules, pustules, nodules, and cysts. Aims: The present study was conducted to investigate the in vitro anti-acne activity of two Unani single drugs Darchini (Cinnamomum zeylanicum Bl.) and Tukhm Khashkhash (Papaver somniferum L. seeds). Materials and Methods: The antibacterial activity of aqueous, ethanolic and hydroalcoholic extracts of both drugs were investigated against two acne causing bacteria, i.e., Propionibacterium acne and Staphylococcus epidermidis using well diffusion method. Results: The result showed that both drugs were active against the two bacteria. Against P. acne aqueous and ethanolic extract of Darchini and Tukhm Khashkhash showed the zone of inhibition of 18 ± 1.02 mm and 18 ± 1.6 mm and 13 ± 1.04 mm and 14 ± 1.8 mm, respectively. Against S. epidermidis aqueous, hydroalcoholic and ethanolic extracts of Darchini showed 22 ± 1.7 mm, 22 ± 1.2 mm and 15 ± 1.8 mm zone of inhibition respectively. Hydroalcoholic and ethanolic extracts of Tukhm Khashkhash showed 15 ± 1.09 mm and 13 ± 1.6 mm zone of inhibition respectively. Conclusion: This suggests that C. zeylanicum and P. somniferum have potential against acne causing bacteria and hence they can be used in topical anti-acne preparations and may address the antibiotic resistance of the bacteria. PMID:25161328

  10. Contact dermatitis to topical acne drugs: a review of the literature.

    PubMed

    Foti, Caterina; Romita, Paolo; Borghi, Alessandro; Angelini, Gianni; Bonamonte, Domenico; Corazza, Monica

    2015-01-01

    Acne vulgaris is a chronic dermatological disorder that affects the majority of teenagers in the Western world. Topical therapy is widely used to treat mild-moderate acne and is known as well-tolerated thanks to its low systemic toxicity, although associated to skin adverse effects. Acne seems to be associated also to an intrinsic alteration of the epidermal barrier, regarding both the upper and the follicular stratum corneum that promotes the onset of such local side effects. The commonest one is irritant contact dermatitis, an event of frequent observation occurring with erythema, burning, dryness, scaling, and itching, usually characterized by low severity and limited duration. Among topical acne drugs, retinoids are the most irritating ones. Another side effect is allergic contact dermatitis: it is rare and mainly associated to benzoyl peroxide. PMID:26302055

  11. Current nanotechnological approaches for an effective delivery of bio-active drug molecules in the treatment of acne.

    PubMed

    Garg, Tarun

    2016-01-01

    Acne is a chronic inflammatory human skin disease, characterized by areas of skin with seborrhoea, comedones, papules, nodules, pimples, and possibly scarring with lesions occurring on face, neck, and back. Nanotechnological approaches such as particulate (solid lipid nanoparticles and microspheres), vesicular (liposomes and niosomes), colloidal drug delivery systems (micro-emulsion and nano-emulsion), and miscellaneous systems (aerosol foams and micro-sponges) have an important place in acne therapy. These approaches have an enormous opportunity for the designing of a novel, low-dose and effective treatment systems to control acne disease. In this review, we specially focus on the different nanotechnological approaches for an effective treatment of acne. PMID:24844191

  12. Acne vulgaris.

    PubMed

    Moradi Tuchayi, Sara; Makrantonaki, Evgenia; Ganceviciene, Ruta; Dessinioti, Clio; Feldman, Steven R; Zouboulis, Christos C

    2015-01-01

    Acne vulgaris is a chronic inflammatory disease - rather than a natural part of the life cycle as colloquially viewed - of the pilosebaceous unit (comprising the hair follicle, hair shaft and sebaceous gland) and is among the most common dermatological conditions worldwide. Some of the key mechanisms involved in the development of acne include disturbed sebaceous gland activity associated with hyperseborrhoea (that is, increased sebum production) and alterations in sebum fatty acid composition, dysregulation of the hormone microenvironment, interaction with neuropeptides, follicular hyperkeratinization, induction of inflammation and dysfunction of the innate and adaptive immunity. Grading of acne involves lesion counting and photographic methods. However, there is a lack of consensus on the exact grading criteria, which hampers the conduction and comparison of randomized controlled clinical trials evaluating treatments. Prevention of acne relies on the successful management of modifiable risk factors, such as underlying systemic diseases and lifestyle factors. Several treatments are available, but guidelines suffer from a lack of data to make evidence-based recommendations. In addition, the complex combination treatment regimens required to target different aspects of acne pathophysiology lead to poor adherence, which undermines treatment success. Acne commonly causes scarring and reduces the quality of life of patients. New treatment options with a shift towards targeting the early processes involved in acne development instead of suppressing the effects of end products will enhance our ability to improve the outcomes for patients with acne. PMID:27189872

  13. Over-the-counter Acne Treatments

    PubMed Central

    Graber, Emmy M.

    2012-01-01

    Acne is a common dermatological disorder that most frequently affects adolescents; however, individuals may be affected at all ages. Many people who suffer from acne seek treatment from both prescription and over-the-counter acne medications. Due to convenience, lower cost, and difficulty getting an appointment with a dermatologist, the use of over-the-counter acne treatments is on the rise. As the plethora of over-the-counter acne treatment options can be overwhelming, it is important that dermatologists are well-versed on this subject to provide appropriate information about treatment regimens and potential drug interactions and that their patients see them as well-informed. This article reviews the efficacy of various over-the-counter acne treatments based on the current literature. A thorough literature review revealed there are many types of over-the-counter acne treatments and each are designed to target at least one of the pathogenic pathways that are reported to be involved in the development of acne lesions. Many of the key over-the-counter ingredients are incorporated in different formulations to broaden the spectrum and consumer appeal of available products. Unfortunately, many over-the-counter products are not well-supported by clinical studies, with a conspicuous absence of double-blind or investigator-blind, randomized, vehicle-controlled studies. Most studies that do exist on over-the-counter acne products are often funded by the manufacturer. Use of over-the-counter acne treatments is a mainstay in our society and it is important that dermatologists are knowledgeable about the different options, including potential benefits and limitations. Overall, over-the-counter acne therapies can be classified into the following five major groups: cleansers, leave-on products, mechanical treatments, essential oils, and vitamins. PMID:22808307

  14. Comparative studies of porphyrin production in Propionibacterium acnes and Propionibacterium granulosum.

    PubMed Central

    Lee, W L; Shalita, A R; Poh-Fitzpatrick, M B

    1978-01-01

    Porphyrin production by Propionibacterium acnes and that by Propionibacterium granulosum were compared. Porphyrin synthesized by both organisms was identified as coproporphyrin III on the bases of absorption and fluorescence spectra and behavior on paper chromatography and thin-layer chromatography. Quantitative, rather than qualitative, differences in production were found between these organisms. In general, P. granulosum produced significantly greater amounts (P less than 0.001) of porphyrin than did P. acnes. delta-Aminolevulinic acid synthetase appeared to be the rate-limiting enzyme of the heme biosynthetic pathway in both organisms. The increased porphyrin production in P. granulosum is apparently associated with increased delta-aminolevulinic acid synthetase activity. PMID:637914

  15. Acne - self-care

    MedlinePlus

    Acne vulgaris - self-care; Cystic acne - self-care; Pimples - self-care; Zits - self-care ... If daily skin care does not clear up blemishes, try over-the-counter acne medicines that you apply to your skin. These products ...

  16. Acne Myths

    MedlinePlus

    ... Sledding, Skiing, Snowboarding, Skating Crushes What's a Booger? Acne Myths KidsHealth > For Kids > Acne Myths Print A ... get your acne under control. Myth: Stress causes acne. Fact: Are you worried that the big test ...

  17. Epidemiology of acne vulgaris.

    PubMed

    Bhate, K; Williams, H C

    2013-03-01

    Despite acne being an almost universal condition in younger people, relatively little is known about its epidemiology. We sought to review what is known about the distribution and causes of acne by conducting a systematic review of relevant epidemiological studies. We searched Medline and Embase to the end of November 2011. The role of Propionibacterium acnes in pathogenesis is unclear: antibiotics have a direct antimicrobial as well as an anti-inflammatory effect. Moderate-to-severe acne affects around 20% of young people and severity correlates with pubertal maturity. Acne may be presenting at a younger age because of earlier puberty. It is unclear if ethnicity is truly associated with acne. Black individuals are more prone to postinflammatory hyperpigmentation and specific subtypes such as 'pomade acne'. Acne persists into the 20s and 30s in around 64% and 43% of individuals, respectively. The heritability of acne is almost 80% in first-degree relatives. Acne occurs earlier and is more severe in those with a positive family history. Suicidal ideation is more common in those with severe compared with mild acne. In the U.S.A., the cost of acne is over 3 billion dollars per year in terms of treatment and loss of productivity. A systematic review in 2005 found no clear evidence of dietary components increasing acne risk. One small randomized controlled trial showed that low glycaemic index (GI) diets can lower acne severity. A possible association between dairy food intake and acne requires closer scrutiny. Natural sunlight or poor hygiene are not associated. The association between smoking and acne is probably due to confounding. Validated core outcomes in future studies will help in combining future evidence. PMID:23210645

  18. [Acne vulgaris: endocrine aspects].

    PubMed

    Dekkers, O M; Thio, B H; Romijn, J A; Smit, J W A

    2006-06-10

    Androgens play an important part in the development of acne vulgaris. Androgen levels in patients with acne are higher than those in controls and people with the androgen insensitivity syndrome do not develop acne. Local factors other than androgen plasma levels, also play a part in the development of acne. The skin contains enzymes that convert precursor hormones to the more potent androgens such as testosterone and dihydrotestosterone. Androgen synthesis can therefore be regulated locally. The effects of androgens on the skin are the result of circulating androgens and enzyme activity in local tissues and androgen receptors. Acne is a clinical manifestation of some endocrine diseases. The polycystic ovary syndrome has the highest prevalence. In women with acne that persists after puberty, in 10-200% of cases polycystic ovary syndrome is later diagnosed. The mechanism of hormonal anti-acne therapy may work by blocking the androgen-production (oestrogens) or by blocking the androgen receptor (cyproterone, spironolactone). PMID:16821451

  19. Treatment considerations for inflammatory acne: clinical evidence for adapalene 0.1% in combination therapies.

    PubMed

    Thiboutot, Diane M; Gollnick, Harald P

    2006-09-01

    Acne vulgaris is an exceptionally common, chronic, and recurring disease. It involves multiple etiological factors including follicular hyperkeratinization, increased sebum production, Propionibacterium acnes proliferation, and inflammation. Presently, oral isotretinoin is the only single agent that is effective against all 4 major pathophysiologic features. However, this drug is also responsible for several serious side effects, including teratogenicity. Therefore, it should be used in only the most severe cases and alternative treatment approaches for inflammatory acne, such as initial combination therapy, should be considered first. Combination therapy in inflammatory acne simultaneously targets multiple pathogenic factors. Current guidelines recommend early initiation of combination therapy with a topical retinoid and antimicrobials for mild to moderate inflammatory acne and topical retinoids with oral antibiotics (with or without the use of benzoyl peroxide) for moderate to severe cases of acne, followed by maintenance therapy with topical retinoids. This review evaluates the rationale and clinical evidence for the use of adapalene in combination therapy for inflammatory acne. PMID:16989194

  20. Multi-drugs resistant acne rosacea in a child affected by Ataxia-Telangiectasia: successful treatment with Isotretinoin.

    PubMed

    Cantarutti, Nicoletta; Claps, Alessia; Angelino, Giulia; Chessa, Luciana; Callea, Francesco; El Hachem, May; Diociaiuti, Andrea; Finocchi, Andrea

    2015-01-01

    Ataxia-Telangiectasia is a rare multisystem autosomal recessive disorder [OMIM 208900], caused by mutations in Ataxia-Telangiectasia Mutated gene. It is characterized by neurological, immunological and cutaneous involvement. Granulomas have been previously reported in Ataxia-Telangiectasia patients, even if acne rosacea has not been described.We report a case of a young Ataxia-Telangiectasia patient with a severe immunological and neurological involvement, who developed granulomatous skin lesions diagnosed by skin biopsy as acne rosacea. Considering the severe clinical picture and the lack of improvement to multiple topic and systemic therapies, treatment with Isotretinoin was started and the skin lesions disappeared after five months. However the therapy was stopped due to drug-hepatotoxicity.Systemic treatment with Isotretinoin should be carefully considered in patient with Ataxia-Telangiectasia for the treatment of multi-drug resistant acne rosacea, however its toxicity may limit long-term use and the risk/benefit ratio of the treatment should be evaluated. PMID:25881033

  1. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Drugs@FDA: FDA Approved Drug Products FDA Home Drug Databases Drugs@FDA - FAQ | Instructions | ... 6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency ...

  2. Moisturizers for Acne

    PubMed Central

    Chularojanamontri, Leena; Tuchinda, Papapit; Kulthanan, Kanokvalai

    2014-01-01

    Acne is a chronic inflammatory disease of the pilosebaceous unit that affects almost all teenagers. Different treatments offer different modes of action, but aim to target acne pathology. Topical therapies, such as benzoyl peroxide, retinoids, antibiotics with alcohol-based preparations, and salicylic acid, can cause skin irritation resulting in a lack of patient adherence. Some physicians recommend patients use moisturizers as adjunctive treatment of acne, especially when either topical benzoyl peroxide or a retinoid is prescribed. Furthermore, some evidence shows that moisturizers can contribute independently to improve signs and symptoms of acne. Moisturizers contain three main properties, which are occlusive, humectant, and emollient effects. Currently, many moisturizers claim to be suitable for acne treatment. This article aims to provide a review of the active ingredients and properties of those moisturizers. Fifty-two moisturizers for acne were included for analysis. Most of the products (92%) have anti-inflammatory properties apart from occlusive, humectant, and emollient effects. Anti-acne medications, including salicylic acid, benzoyl peroxide, and retinol, were found respectively in 35, 10, and 8 percent of the moisturizer products containing anti-inflammatory properties. More than half of the products contain dimethicone and/or glycerin for its moisturizer property. Aloe vera and witch hazel are botanical anti-inflammatories that were commonly found in this study. Scientific data regarding some ingredients are discussed to provide a guide for physicians in selecting moisturizers for acne patients. PMID:24847408

  3. Contraceptive use in acne.

    PubMed

    Lam, Charlene; Zaenglein, Andrea L

    2014-01-01

    Acne vulgaris is an inflammatory disorder of the pilosebaceous follicle. It is well established that androgen hormones play a major role in sebum production and excretion, and are vital in the pathogenesis of acne. Isotretinoin notwithstanding, hormonal therapies such as combined oral contraceptives (COCs) and spironolactone are the only treatments that can affect sebum production and the androgen component of acne. Contraceptives are also used during isotretinoin therapy for pregnancy prevention. It is important for a dermatologist to be familiar with all the available methods of contraception to provide essential counseling to patients. The aim of this paper is to review the role of hormones in acne pathogenesis, discuss the use of hormonal therapies for acne, and detail various alternative contraceptive methods in relation to isotretinoin treatment and pregnancy prevention. PMID:25017461

  4. Inhibitory effects of wild bitter melon leaf extract on Propionibacterium acnes-induced skin inflammation in mice and cytokine production in vitro.

    PubMed

    Huang, Wen-Cheng; Tsai, Tsung-Hsien; Huang, Ching-Jang; Li, You-Yi; Chyuan, Jong-Ho; Chuang, Lu-Te; Tsai, Po-Jung

    2015-08-01

    Propionibacterium acnes is a key pathogen involved in acne inflammation. Wild bitter melon (WBM, Momordica charantia L. var. abbreviate Seringe) is consumed as both a vegetable and as folk medicine in Taiwan. We examined the inhibitory activity of the total phenolic extract (TPE) of WBM leaf on P. acnes-induced inflammatory responses in vivo and in vitro. Our data showed that TPE significantly attenuated P. acnes-induced ear swelling in mice along with microabscess. Flow cytometry analysis revealed that TPE treatment significantly decreased the migration of neutrophils and interleukin (IL)-1β(+) populations in vivo. In P. acnes-stimulated human monocytic THP-1 cells, TPE suppressed the mRNA levels and production of IL-8, IL-1β, and tumor necrosis factor (TNF)-αin vitro. In addition, TPE suppressed P. acnes-induced matrix metalloproteinase-9 levels. TPE blocked nuclear factor-κB (NF-κB) activation and inactivated mitogen-activated protein kinases (MAPK); these actions may partially account for its inhibitory effect on cytokine production. The quantitative HPLC analysis revealed gallic, chlorogenic, caffeic, ferulic, and cinnamic acids, myricetin, quercetin, luteolin, apigenin, and thymol in TPE. All these phenolics significantly suppressed P. acnes-induced IL-8 production in vitro. Our results suggest that WBM leaf extract effectively inhibits P. acnes-induced inflammatory responses and may be useful to relieve the inflammation of acne. PMID:26098998

  5. Optical treatments for acne.

    PubMed

    Ross, E Victor

    2005-01-01

    Light-based treatments for acne are becoming increasingly commonplace in dermatology. This article reviews various light approaches in acne therapy. Methods are discussed from an anatomical and a functional perspective. The emphasis is on the practicality of treatment as well as the pros and cons of various devices. Also, a review of the recent literature is presented. The article is intended to give the reader a panoramic view of this still-young and developing area. Most likely, light-based acne treatment will receive more popularity as dermatologists learn how to integrate this type of therapy within the context of more established drug agents. PMID:16229726

  6. Laser Acne Treatment

    MedlinePlus

    ... rashes clinical tools newsletter | contact Share | Acne Treatment, Laser A A A BEFORE: This patient wanted laster ... A popular approach is to combine an infrared laser with skin cooling to target oil gland production, ...

  7. Effective over-the-counter acne treatments.

    PubMed

    Bowe, Whitney P; Shalita, Alan R

    2008-09-01

    Acne is the most common disease of the skin, yet only a fraction of acne sufferers are treated with prescription products by physicians. There is, however, a large and expanding market for over-the-counter (OTC) medications, many of which are not only effective but also well tolerated and cosmetically elegant. Given the presence of OTC acne medications on the television, the Internet, and store shelves, patients will be acutely aware of these OTC remedies and will have questions. Patients will expect dermatologists to advise them regarding products to use either as a sole therapy or in combination with prescription drugs. Recently, combinations of OTC acne medications in treatment regimens or "kits" have gained popularity and appear to have increased patient compliance. Quality-of-life outcomes from OTC medication use, in at least one study, have demonstrated good benefit. The most common OTC ingredients include benzoyl peroxide, a potent antibacterial agent, and salicylic acid, a mild comedolytic and antiinflammatory medication. Other, less-common OTC ingredients include sulfur, sodium sulfacetamide, and alpha hydroxy acids. Zinc, vitamin A, tea tree oil, and ayurvedic therapies also are available OTC for acne. Additional and better studies are needed to clarify the benefit of these latter medications. PMID:18786494

  8. [Acne vulgaris. Role of cosmetics].

    PubMed

    Korting, H C; Borelli, C; Schöllmann, C

    2010-02-01

    Appropriate cosmetics for skin cleansing are capable of contributing to a reduction of especially inflammatory lesions in acne-prone patients and to support pharmacological intervention in patients with manifest acne. Cleansing of acne-prone skin should employ acidified synthetic cleansers with a pH of 5.5 rather than soap. Furthermore, the ingredients of certain skin care products, i.e. nicotinamide, lactic acid, triethyl acetate/ethyllineolate, and prebiotic plant extracts, affect different mechanisms of acne pathogenesis and therefore may contribute to a decrease in acne lesions. At least some of these ingredients underscore the concept of evidence-based cosmetics. In contrast, the problem of acne lesions caused by comedogenic ingredients in cosmetics today is negligible. PMID:20107752

  9. Successful treatment of mild to moderate acne vulgaris with Dr Michaels® (also branded as Zitinex®) topical products family: a clinical trial.

    PubMed

    Wollina, U; Tirant, M; Bayer, P; Coburn, M; Anderson, P; Donnelly, B; Kennedy, T; Gaibor, J; Arora, M; Clews, L; Walmsley, S; Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Novotny, F; Roccia, M G; Maximov, G K; França, K; Lotti, T

    2016-01-01

    Acne vulgaris is an epidemic inflammatory skin disease of multi-factorial origin, frequently seen in adolescents and often persisting or occurring through to adulthood. Acne vulgaris is a nearly universal skin disease afflicting 79-95% of the adolescent population in westernized societies and is a significant cause of psychological morbidity in affected patients. Despite the various treatment options available for acne, there is still a need for a safe and effective option. The aim of the study was to investigate the efficacy and tolerability of Dr Michaels® (Zitinex®) product family in the treatment of papulo-pustular acne. 25 patients (17 female/8 male), aged 15-22, with a mild to moderate papulo-pustular acne, localized on the face and on the trunk, were included in this study. None of the patients had used any other kind of treatment in the 3 months prior to commencing this study. All of the patients were treated with Dr Michaels® (Zitinex®) facial exfoliating cleanser, activator formula, a cream, PSC 200 and PSC 900 oral supplements. Application time of Dr Michaels® (Zitinex®) products was 12 weeks. The treatment was been evaluated clinically at 0, 4, 8 and 12 weeks. All of the patients showed an improvement in all parameters of their acne (comedones, papules, pustules, hyperpigmentation and scars). The acne lesions and erythema had mostly resolved. The hyperpigmentation and pitted scarring had significantly reduced also, with the skin appearing smoother. The treatment was well tolerated and no side effects have been described. Our study demonstrates that the Dr Michaels® (Zitinex®) facial exfoliating cleanser, activator formula, cream and oral supplements PSC 200 and PSC 900 are an effective therapeutic option for the treatment of moderately severe acne vulgaris. Moreover, it highlights the safety profile of the Dr Michaels® (Zitinex®) product family in a case of acne compared to traditional first-line treatments. PMID:27498658

  10. Acne vulgaris in children and adolescents.

    PubMed

    Schnopp, C; Mempel, M

    2011-08-01

    Acne vulgaris is a very common inflammatory skin disease originating from the pilosebaceous unit. Peak incidence is at puberty, but acne can affect all age groups. Prepubertal acne is rare, but important to recognize as diagnostic and therapeutic procedures differ from pubertal acne. Acne neonatorum is a mild, self-limiting disease, whereas acne infantum commonly presents with moderate to severe lesions and high risk of scarring thus requiring early intervention. Mid-childhood or prepubertal acne raises the suspicion of hyperandrogenemia, further investigations are indicated to rule out underlying disease. The same applies to any patient with very severe acne, acne not responding to therapy or unusual clinical presentation. Etiopathogenesis of acne is not yet fully understood. Familiy history is the most important risk factor to develop severe acne and scarring. The relevance of life style factors such as smoking or diet is controversial. Lately high carbohydrate diet and dairy products have been implicated as aggravating factors. Mild acne normally responds to topical monotherapy, in moderate disease combination of two synergistically acting substances (e.g. benzoyl peroxid plus antibiotic, benzoyl peroxid plus retinoid, retinoid plus antibiotic, benzoyl peroxid plus azelaic acid) will improve clinical response. Retinoids and/or benzoylperoxid have been shown to be effective in maintenance therapy. In patients with severe disease or high risk of scarring systemic therapy with antibiotics, oral contraceptives with antiandrogenic properties and in particularly isotretinoin as most effective acne treatment should be considered early to avoid physical and emotional scars. PMID:21909065

  11. Acne mechanica.

    PubMed

    Mills, O H; Kligman, A

    1975-04-01

    The term acne mechanica designates local exacerbations due to pressure, friction, rubbing, squeezing, or stretching. Examples are given of various physical traumata that provoke lesions in acne patients. The precipitating causes of stress are diverse, they include articles of clothing (tight straps and belts), recreational accouterments (football shoulder pads), or occupational pressure (rubbing of back in truck drivers). Sealing acne-bearing skin under adhesive for two weeks regularly induced new inflammatory lesions, which derived from the rupture of microcomedones that are not visible to the naked eye. PMID:123732

  12. [Cosmetic treatments and acne].

    PubMed

    Poli, Florence

    2002-04-15

    Cosmetic products contribute to the efficacy of anti-acneic treatment. Cleaning bars without soap and lotions are to be preferred to soaps. Morning application of moisturizing creams compensate for dryness and irritation induced by topical treatment. Some of these cosmetic products may have a limited efficacy of the shiny appearance and/or acne lesions. Scrubs, abrasive sponges, masks and patches have a very limited usefulness. Make up and camouflage techniques are authorized, provided that the products have been tested non comedogenic and non acne-genic. PMID:12053795

  13. Acne: Treatment

    MedlinePlus

    ... the-counter medicines for acne. These medicines kill bacteria, dry up skin oil, and make your skin ... Antibiotics such as minocycline, doxycycline, and tetracycline reduce bacteria and inflammation, and can be used in combination ...

  14. Acne Scars

    MedlinePlus

    ... scars. Cryosurgery : This treatment freezes the scar tissue. Freezing the tissue causes it to die and gradually ... et al . “Which Type of Atrophic Acne Scar (Ice-pick, Boxcar, or Rolling) Responds to Nonablative Fractional ...

  15. The Role of Skin Care as an Integral Component in the Management of Acne Vulgaris: Part 1: The Importance of Cleanser and Moisturizer Ingredients, Design, and Product Selection

    PubMed Central

    Del Rosso, James Q.

    2013-01-01

    Acne vulgaris is a very common facial skin disorder accounting for approximately 10 percent of all visits to ambulatory dermatology practices across the United States annually. Over time, greater attention has been directed to the roles of multiple epidermal barrier functions in various dermatological disorders, especially the stratum corneum permeability barrier and antimicrobial barrier. As a result, it has become readily apparent that professional direction of skin care is very important in the overall management of acne vulgaris. This article discusses several reasons that support the importance of incorporating specified skin care recommendations and instructions into the overall management plan for acne vulgaris. In addition, the article reviews formulation characteristics and some of the scientific data on two commercially available products that are recommended for use as a skin care regimen in patients with acne-prone and acne-affected skin, a foam wash and a moisturizer with a sun protection factor 30 broad spectrum photoprotection rating. The rationale for inclusion of specific ingredients are discussed along with an overview of research results including use in patients with acne vulgaris. PMID:24765221

  16. Propionibacterium acnes promotes Th17 and Th17/Th1 responses in acne patients.

    PubMed

    Kistowska, Magdalena; Meier, Barbara; Proust, Tatiana; Feldmeyer, Laurence; Cozzio, Antonio; Kuendig, Thomas; Contassot, Emmanuel; French, Lars E

    2015-01-01

    Propionibacterium acnes is a Gram-positive commensal bacterium thought to be involved in the pathogenesis of acne vulgaris. Although the ability of P. acnes in the initiation of pro-inflammatory responses is well documented, little is known about adaptive immune responses to this bacterium. The observation that infiltrating immune cells consist mainly of CD4(+) T cells in the perifollicular space of early acne lesions suggests that helper T cells may be involved in immune responses caused by the intra-follicular colonization of P. acnes. A recent report showing that P. acnes can induce IL-17 production by T cells suggests that acne might be a T helper type 17 (Th17)-mediated disease. In line with this, we show in this work that, in addition to IL-17A, both Th1 and Th17 effector cytokines, transcription factors, and chemokine receptors are strongly upregulated in acne lesions. Furthermore, we found that, in addition to Th17, P. acnes can promote mixed Th17/Th1 responses by inducing the concomitant secretion of IL-17A and IFN-γ from specific CD4(+) T cells in vitro. Finally, we show that both P. acnes-specific Th17 and Th17/Th1 cells can be found in the peripheral blood of patients suffering from acne and, at lower frequencies, in healthy individuals. We therefore identified P. acnes-responding Th17/Th1 cells as, to our knowledge, a previously unreported CD4(+) subpopulation involved in inflammatory acne. PMID:25010142

  17. Inflammatory Acne Treatment: Review of Current and New Topical Therapeutic Options.

    PubMed

    Zeichner, Joshua A

    2016-01-01

    Acne vulgaris (AV) is an inflammatory skin disease characterized by the presence of comedones, papules, pustules, and nodules. Consensus guidelines recommend the use of combination therapy using different drugs with complementary mechanisms of action to best address as many acne pathogenic factors as possible at the same time. Topical acne medications exist as individual agents that may be combined in physician-recommended regimens or as pre-formulated fixed-dose combination products. In addition, there are several new and promising topical therapies currently being developed that work by different mechanisms of action from traditionally used acne therapies. The following review will cover commonly used drugs, newcomers to the market, and what the future holds for the topical treatment of AV. PMID:26741391

  18. 75 FR 9767 - Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-04

    ...We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC......

  19. Can Acne Scars Be Removed?

    MedlinePlus

    ... Can I Help a Friend Who Cuts? Can Acne Scars Be Removed? KidsHealth > For Teens > Can Acne ... eliminarse las marcas de acne? Different Types of Acne Scars from acne can seem like double punishment — ...

  20. Zapping Those Zits: Helping Teens Handle Acne.

    ERIC Educational Resources Information Center

    Martin, Paul

    1992-01-01

    Describes five types of acne and stresses the importance of appropriate treatment. Some dermatologists believe diet is critical in improving acne. Other treatments include the use of drying lotions and soaps, astringents, abrasive cleansers, prescription drugs, face peels, and dermabrasion. (SM)

  1. Properties of herbal extracts against Propionibacterium acnes for biomedical application

    NASA Astrophysics Data System (ADS)

    Lim, Youn-Mook; Kim, Sung Eun; Kim, Yong Soo; Shin, Young Min; Jeong, Sung In; Jo, Sun-Young; Gwon, Hui-Jeong; Park, Jong-seok; Nho, Young-Chang; Kim, Jong-Cheol; Kim, Seong-Jang; Shin, HeungSoo

    2012-10-01

    Propionibacterium acnes (P. acnes), one of the anaerobic bacterium, causes inflammatory acne. To find a novel medication for treating the inflammation caused by P. acnes, we investigated the anti-bacterial and anti-inflammatory activities of several herbal extracts against P. acnes. The aqueous extracts from five dried herbs, Phellodendron amurense Rupr., Paeonia lactiflora Pallas., Houttuynia cordata Thunb., Agrimonia pilosa Ledeb. and Glycyrrhiza uralensis Fisch., were prepared and mixed. In this experiment, 1 mg/ml of the herbal extract mixture caused a decrease in the growth of P. acnes and reduced the production of pro-inflammatory cytokines, TNF-α, IL-8, IL-1β and IL-6, in human monocytic THP-1 cells treated with heat-killed P. acnes. Therefore, this herbal extract mixture may possess both anti-bacterial and anti-inflammatory activities against P. acnes and can be a novel therapeutic agent for treating inflammatory acne.

  2. Acne vulgaris

    PubMed Central

    Aydemir, Ertuğrul H.

    2014-01-01

    Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit and it is observed equally in both sexes and nearly all races. It generally begins at puberty, but the healing period is variable. There is no known etiological factor, except genetic tendency. Androgens play a very limited role in some female patients. The effects of cosmetics, foods and drinks are also discussible and too limited. There are four factors in acne pathogenesis: Increase of the sebum excretionKeratinization of infrainfundibulumBacterial colonization of the follicleInflammation It is mainly observed on the face and back, shoulders and chest. Initial lesions are comedons. Papules, pustules and cysts of severe types follow it. The most important factor in treatment is a very good patient-physician communication. Topical or systemic treatment or both can be used depending on the severity of acne. Benzoyl peroxyde, azelaic acid, AHA’s antibiotics, retinoic acid and derivatives are the topical choices. For systemic treatment antibiotics are the most commonly used medicines, but isotretinoine has a very spesific place with the possibility of permanent healing. All kind of treatments need approximately six months for a good result. PMID:26078626

  3. Understanding the Burden of Adult Female Acne

    PubMed Central

    Kawata, Ariane K.; Daniels, Selena R.; Yeomans, Karen; Burk, Caroline T.; Callender, Valerie D.

    2014-01-01

    Objective: Typically regarded as an adolescent condition, acne among adult females is also prevalent. Limited data are available on the clinical characteristics and burden of adult female acne. The study objective was to describe clinical characteristics and psychosocial impact of acne in adult women. Design: Cross-sectional, web-based survey. Setting: Data were collected from a diverse sample of United States females. Participants: Women ages 25 to 45 years with facial acne (≥25 visible lesions). Measurements: Outcomes included sociodemographic and clinical characteristics, perceptions, coping behaviors, psychosocial impact of acne (health-related quality of life using acne-specific Quality of Life questionnaire and psychological status using Patient Health Questionnaire), and work/productivity. Results: A total of 208 women completed the survey (mean age 35±6 years), comprising White/Caucasian (51.4%), Black/African American (24.5%), Hispanic/Latino (11.1%), Asian (7.7%), and Other (5.3%). Facial acne presented most prominently on cheeks, chin, and forehead and was characterized by erythema, postinflammatory hyperpigmentation, and scarring. Average age of adult onset was 25±6 years, and one-third (33.7%) were diagnosed with acne as an adult. The majority (80.3%) had 25 to 49 visible facial lesions. Acne was perceived as troublesome and impacted self-confidence. Makeup was frequently used to conceal acne. Facial acne negatively affected health-related quality of life, was associated with mild/moderate symptoms of depression and/or anxiety, and impacted ability to concentrate on work or school. Conclusion: Results highlight the multifaceted impact of acne and provide evidence that adult female acne is under-recognized and burdensome. PMID:24578779

  4. Antimicrobial Property of Lauric Acid Against Propionibacterium acnes: Its Therapeutic Potential for Inflammatory Acne Vulgaris

    PubMed Central

    Nakatsuji, Teruaki; Kao, Mandy C.; Fang, Jia-You; Zouboulis, Christos C.; Zhang, Liangfang; Gallo, Richard L.; Huang, Chun-Ming

    2009-01-01

    The strong bactericidal properties of lauric acid (C12:0), a middle chain-free fatty acid commonly found in natural products, have been shown in a number of studies. However, it has not been demonstrated whether lauric acid can be used for acne treatment as a natural antibiotic against Propionibacterium acnes (P. acnes), which promotes follicular inflammation (inflammatory acne). This study evaluated the antimicrobial property of lauric acid against P. acnes both in vitro and in vivo. Incubation of the skin bacteria P. acnes, Staphylococcus aureus (S. aureus), and Staphylococcus epidermidis (S. epidermidis) with lauric acid yielded minimal inhibitory concentration (MIC) values against the bacterial growth over 15 times lower than those of benzoyl peroxide (BPO). The lower MIC values of lauric acid indicate stronger antimicrobial properties than that of BPO. The detected values of half maximal effective concentration (EC50) of lauric acid on P. acnes, S. aureus, and S. epidermidis growth indicate that P. acnes is the most sensitive to lauric acid among these bacteria. In addition, lauric acid did not induce cytotoxicity to human sebocytes. Notably, both intradermal injection and epicutaneous application of lauric acid effectively decreased the number of P. acnes colonized with mouse ears, thereby relieving P. acnes-induced ear swelling and granulomatous inflammation. The obtained data highlight the potential of using lauric acid as an alternative treatment for antibiotic therapy of acne vulgaris. PMID:19387482

  5. A Review of Acne in Ethnic Skin

    PubMed Central

    Davis, Erica C.

    2010-01-01

    Acne vulgaris is one of the most common conditions for which all patients, including those with skin of color (Fitzpatrick skin types IV–VI), seek dermatological care. The multifactorial pathogenesis of acne appears to be the same in ethnic patients as in Caucasians. However, there is controversy over whether certain skin biology characteristics, such as sebum production, differ in ethnic patients. Clinically, acne lesions can appear the same as those seen in Caucasians; however, histologically, all types of acne lesions in African Americans can be associated with intense inflammation including comedones, which can also have some degree of inflammation. It is the sequelae of the disease that are the distinguishing characteristics of acne in skin of color, namely postinflammatory hyperpigmentation and keloidal or hypertrophic scarring. Although the medical and surgical treatment options are the same, it is these features that should be kept in mind when designing a treatment regimen for acne in skin of color. PMID:20725545

  6. Acne and diet: facts and controversies.

    PubMed

    Rezaković, Saida; Bukvić Mokos, Zrinka; Basta-Juzbašić, Aleksandra

    2012-01-01

    Acne is a common skin disorder characterized by follicular hyperkeratinization and obstruction of the pilosebaceous follicles, androgen stimulated sebum production, colonization of the follicles by Propionibacterium acne, and inflammation. A large number of epidemiological studies have shown a low incidence of acne in non-Western societies, suggesting that diet might be an important factor in acne pathogenesis, particularly in mediating inflammation, oxidative stress and androgen stimulation in the acne process. Consequently, it has been hypothesized that diet might have a preventive or therapeutic effect in this skin disorder. Since the majority of recent data have not been consistent, the aim of this article is to present current knowledge and scientific assumptions on the relationship between diet and acne. PMID:23069302

  7. Topical Treatment With an Agent Disruptive to P. acnes Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial.

    PubMed

    Bernhardt, Michael J; Myntti, Matthew F

    2016-06-01

    The traditional disease model of acne has been one of follicular plugging due to 'sticky epithelial cells' associated with increased sebum production with deep follicular anaerobic conditions favoring P. acnes- generated inflammation. P. acnes biofilms have been found more frequently in patients with acne than controls. Biofilms are genetically coded to create adhesion to the pilosebaceous unit followed by production of a mucopolysaccharide coating capable of binding to lipid surfaces. Traditional therapies for acne have involved mixtures of oral and topical antibiotics admixed with topical keratolytics and retinoids, which are aimed at traditional bacterial reduction as well as downregulating the inflammatory cascade. These approaches are limited by side effect and compliance/tolerability issues. As the P. acnes biofilm may, in fact, be the instigator of this process, we studied the use of a topical agent designed to reduce the P. acnes biofilm to see if reducing the biofilm would be therapeutically efficacious. We present data of a proprietary topical non-prescription agent with a novel pharmaco mechanism designed to attack the biofilm produced by P. acnes. Our data shows a decrease of inflammatory lesions by 44% and non-inflammatory lesions by 32% after 12 weeks and also provided for a meaningful improvement in the quality of life of the patients in the study. These improvements were achieved with a product that was not associated with burning, chafing, irritation, or erythema, which can be seen with topical treatments. It is apparent from this study that by addressing the biofilm which protects the P. acnes bacteria through the use of the Acne Gel, the incidence of acne symptoms can be greatly reduced, while having no negative impacts on the patients' skin (ClinicalTrials.gov registry number NCT02404285).

    J Drugs Dermatol. 2016;15(6):677-683. PMID:27272073

  8. Comb and brush acne.

    PubMed

    Petrozzi, J W

    1980-12-01

    Frequent combing or brushing of the hair may result in an exacerbation of existing acne or be the cause of localized acne. Because of today's hair styling habits and methods, this type of acne is commonly encountered but poorly appreciated by physicians. Patient education is the most important factor in the management of this condition. Comb and brush acne is another external factor to be added to the list of causes of "acne mechanica." PMID:6449356

  9. [Acne and diet].

    PubMed

    Melnik, B C

    2013-04-01

    In industrialized countries acne presents as an epidemic disease of civilization affecting sebaceous follicles of adolescents and young adults, associated with increased body mass index and insulin resistance. "Western style" diet, characterized by high glycaemic load and increased consumption of insulinotropic milk proteins, plays an important role in acne pathogenesis. On the cellular level, nutrient-derived metabolic signals are sensed by the metabolic transcription factor FoxO1 and integrated by the regulatory kinase mTORC1. mTORC1, the central hub of protein- and lipid biosynthesis, cell growth and proliferation, is activated by insulin, IGF-1 and branched-chain essential amino acids, especially leucine. The understanding of Western diet-mediated nutrient signalling with over-activated mTORC1 offers a reasonable approach for dietary intervention in acne by lowering glycaemic load and consumption of milk and milk products. A suitable diet attenuating increased mTORC1 activity is a Palaeolithic-like diet with reduced intake of sugar, hyperglycaemic grains, milk and milk products but enriched consumption of vegetables and fish. PMID:23529682

  10. Effects of fish oil supplementation on inflammatory acne

    PubMed Central

    2012-01-01

    Background Given that acne is a rare condition in societies with higher consumption of omega-3 (n-3) relative to omega-6 (n-6) fatty acids, supplementation with n-3 may suppress inflammatory cytokine production and thereby reduce acne severity. Methods 13 individuals with inflammatory acne were given three grams of fish oil containing 930 mg of EPA to their unchanged diet and existing acne remedies for 12 weeks. Acne was assessed using an overall severity grading scale, total inflammatory lesion counts, and colorimetry. Findings There was no significant change in acne grading and inflammatory counts at week 12 compared to baseline. However, there was a broad range of response to the intervention on an individual basis. The results showed that acne severity improved in 8 individuals, worsened in 4, and remained unchanged in 1. Interestingly, among the individuals who showed improvement, 7 were classified as having moderate to severe acne at baseline, while 3 of the 4 whose acne deteriorated were classified as having mild acne. Conclusion There is some evidence that fish oil supplementation is associated with an improvement in overall acne severity, especially for individuals with moderate to severe acne. Divergent responses to fish oil in our pilot study indicates that dietary and supplemental lipids are worthy of further investigation in acne. PMID:23206895

  11. Dark chocolate exacerbates acne.

    PubMed

    Vongraviopap, Saivaree; Asawanonda, Pravit

    2016-05-01

    The effects of chocolate on acne exacerbations have recently been reevaluated. For so many years, it was thought that it had no role in worsening acne. To investigate whether 99% dark chocolate, when consumed in regular daily amounts, would cause acne to worsen in acne-prone male subjects, twenty-five acne prone male subjects were asked to consume 25 g of 99% dark chocolate daily for 4 weeks. Assessments which included Leeds revised acne scores as well as lesion counts took place weekly. Food frequency questionnaire was used, and daily activities were recorded. Statistically significant changes of acne scores and numbers of comedones and inflammatory papules were detected as early as 2 weeks into the study. At 4 weeks, the changes remained statistically significant compared to baseline. Dark chocolate when consumed in normal amounts for 4 weeks can exacerbate acne in male subjects with acne-prone skin. PMID:26711092

  12. Moisturizers for Acne: What are their Constituents?

    PubMed

    Chularojanamontri, Leena; Tuchinda, Papapit; Kulthanan, Kanokvalai; Pongparit, Kamolwan

    2014-05-01

    Acne is a chronic inflammatory disease of the pilosebaceous unit that affects almost all teenagers. Different treatments offer different modes of action, but aim to target acne pathology. Topical therapies, such as benzoyl peroxide, retinoids, antibiotics with alcohol-based preparations, and salicylic acid, can cause skin irritation resulting in a lack of patient adherence. Some physicians recommend patients use moisturizers as adjunctive treatment of acne, especially when either topical benzoyl peroxide or a retinoid is prescribed. Furthermore, some evidence shows that moisturizers can contribute independently to improve signs and symptoms of acne. Moisturizers contain three main properties, which are occlusive, humectant, and emollient effects. Currently, many moisturizers claim to be suitable for acne treatment. This article aims to provide a review of the active ingredients and properties of those moisturizers. Fifty-two moisturizers for acne were included for analysis. Most of the products (92%) have anti-inflammatory properties apart from occlusive, humectant, and emollient effects. Anti-acne medications, including salicylic acid, benzoyl peroxide, and retinol, were found respectively in 35, 10, and 8 percent of the moisturizer products containing anti-inflammatory properties. More than half of the products contain dimethicone and/or glycerin for its moisturizer property. Aloe vera and witch hazel are botanical anti-inflammatories that were commonly found in this study. Scientific data regarding some ingredients are discussed to provide a guide for physicians in selecting moisturizers for acne patients. PMID:24847408

  13. Propionibacterium acnes in the pathogenesis and immunotherapy of acne vulgaris.

    PubMed

    Liu, Pei-Feng; Hsieh, Yao-Dung; Lin, Ya-Ching; Two, Aimee; Shu, Chih-Wen; Huang, Chun-Ming

    2015-01-01

    Acne vulgaris, a multi-factorial disease, is one of the most common skin diseases, affecting an estimated 80% of Americans at some point during their lives. The gram-positive and anaerobic Propionibacterium acnes (P. acnes) bacterium has been implicated in acne inflammation and pathogenesis. Therapies for acne vulgaris using antibiotics generally lack bacterial specificity, promote the generation of antibiotic-resistant bacterial strains, and cause adverse effects. Immunotherapy against P. acnes or its antigens (sialidase and CAMP factor) has been demonstrated to be effective in mice, attenuating P. acnes-induced inflammation; thus, this method may be applied to develop a potential vaccine targeting P. acnes for acne vulgaris treatment. This review summarizes reports describing the role of P. acnes in the pathogenesis of acne and various immunotherapy-based approaches targeting P. acnes, suggesting the potential effectiveness of immunotherapy for acne vulgaris as well as P. acnes-associated diseases. PMID:26264195

  14. Diet and acne.

    PubMed

    Bowe, Whitney P; Joshi, Smita S; Shalita, Alan R

    2010-07-01

    Historically, the relationship between diet and acne has been highly controversial. Before the 1960s, certain foods were thought to exacerbate acne. However, subsequent studies dispelled these alleged associations as myth for almost half a century. Several studies during the last decade have prompted dermatologists to revisit the potential link between diet and acne. This article critically reviews the literature and discusses how dermatologists might address diet when counseling patients with acne. Dermatologists can no longer dismiss the association between diet and acne. Compelling evidence exists that high glycemic load diets may exacerbate acne. Dairy ingestion appears to be weakly associated with acne, and the roles of omega-3 fatty acids, antioxidants, zinc, vitamin A, and dietary fiber remain to be elucidated. This study was limited by the lack of randomized controlled trials in the literature. We hope that this review will encourage others to explore the effects of diet on acne. PMID:20338665

  15. Can I Prevent Acne?

    MedlinePlus

    ... I Help a Friend Who Cuts? Can I Prevent Acne? KidsHealth > For Teens > Can I Prevent Acne? Print A A A Text Size What's ... too. Although there is no surefire way to prevent acne, try these tips to help reduce the ...

  16. Canadian Drug Products Containing ASA

    PubMed Central

    Parker, William A.; Shearer, Cameron A.; Kirkpatrick, Susan L.

    1977-01-01

    A list of nearly 200 Canadian ASA-containing drug products is presented. Information was supplied by the major pharmaceutical companies and data were also obtained from various Canadian reference sources. This information should aid the physician and other health-related personnel in identifying ASA-containing products and counselling the salicylate-endangered patient. PMID:21304856

  17. Drugs and other product choices.

    PubMed

    Hyman, Paul M; Carvajal, Ricardo

    2009-01-01

    Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of a dermatological product can vary widely. Most prescription and some over-the-counter drugs and medical devices are approved by the FDA based on scientific data. Most over-the-counter drugs are marketed in compliance with FDA regulations based on expert medical review. The FDA clears most medical devices based on their substantial equivalence to other legally marketed devices. Cosmetics, medical foods, and dietary supplements are subject only to general postmarket prohibitions against adulterated and misbranded products, although the FDA may review ingredient safety and specific claims for dietary supplements. Some product information is available on FDA's Web site, but the prudent physician should supplement that information by reviewing available scientific literature. PMID:19453345

  18. Diet in acne: further evidence for the role of nutrient signalling in acne pathogenesis.

    PubMed

    Melnik, Bodo C

    2012-05-01

    Recent evidence underlines the role of Western diet in the pathogenesis of acne. Acne is absent in populations consuming Palaeolithic diets with low glycaemic load and no consumption of milk or dairy products. Two randomized controlled studies, one of which is presented in this issue of Acta Dermato-Venereologica, have provided evidence for the beneficial therapeutic effects of low glycaemic load diets in acne. Epidemiological evidence confirms that milk consumption has an acne-promoting or acne-aggravating effect. Recent progress in understanding the nutrient-sensitive kinase mammalian target of rapamycin complex 1 (mTORC1) allows a new view of nutrient signalling in acne by both high glycaemic load and increased insulin-, IGF-1-, and leucine signalling due to milk protein consumption. Acne should be regarded as an mTORC1-driven disease of civilization, like obesity, type 2 diabetes and cancer induced by Western diet. Early dietary counselling of teenage acne patients is thus a great opportunity for dermatology, which will not only help to improve acne but may reduce the long-term adverse effects of Western diet on more serious mTORC1-driven diseases of civilization. PMID:22419445

  19. Acne in hirsute women

    PubMed Central

    Pupovci, Hatixhe Latifi; Berisha, Violeta Lokaj; Goçi, Aferdita Uka; Gerqari, Antigona

    2014-01-01

    Introduction Acne and hirsutism are common manifestations of hyperandrogenism. Aim To investigate whether or not acne is present in women with hirsutism, associated with different clinical, endocrine and ultrasonographic features. Material and methods The prospective study included 135 women with hirsutism, aged 14–46 years. We measured the levels of hormones with radioimmunoassay/immunoradiometric assay methods. Results Acne were present in 63 (47.6%) women with hirsutism. Sixty women had mild forms of acne, including: whiteheads, blackheads, papules and pustules. Only 3 women had moderate to severe acne, including nodules. In a group of women with hirsutism and acne, 6 (9.5%) were obese. In our study we found a high prevalence of androgen excess among hirsute women with acne: total testosterone was increased in 79%, free testosterone in 20.6%, androstenedione in 69.8%, dehydroepiandrosterone sulfate (DHEAS) in 30.1%, 17-OH-progesterone 68.2% and sex hormone-binding globulin (SHBG) was decreased in 33.3% of women. Women with hirsutism and acne have received oral contraceptives for a year, without or in a combination with other medication. Thirty-four (53.9%) women have shown improvement in hirsutism and acne. Conclusions In this study we found a high prevalence of acne in hirsute women. The prevalence of acne was higher in polycystic ovarian syndrome. Since these women have associated endocrine changes it is important to correct them with hormonal therapy. PMID:25610349

  20. Acne in women.

    PubMed

    Ramos-e-Silva, M; Ramos-e-Silva, S; Carneiro, S

    2015-07-01

    This review focuses on the subject of acne in women, a disease that is increasingly common and that can also affect men. Adult acne differs from the type of acne that occurs in teenagers, and it may persist beyond adolescence or have its onset at an older age (adult-onset acne or late acne). Acne can have a negative impact on the quality of life of patients at any age, leading to a negative body image and decrease in self-esteem, and in older patients it can result in discrimination in the workplace and in other social environments. Acne in women must be understood as a specific problem, and here we discuss the pathogenesis, clinical presentation, psychology and treatment of this very prevalent problem. PMID:25597414

  1. Propionibacterium acnes CAMP Factor and Host Acid Sphingomyelinase Contribute to Bacterial Virulence: Potential Targets for Inflammatory Acne Treatment

    PubMed Central

    Nakatsuji, Teruaki; Tang, De-chu C.; Zhang, Liangfang; Gallo, Richard L.; Huang, Chun-Ming

    2011-01-01

    Background In the progression of acne vulgaris, the disruption of follicular epithelia by an over-growth of Propionibacterium acnes (P. acnes) permits the bacteria to spread and become in contact with various skin and immune cells. Methodology/Principal Findings We have demonstrated in the present study that the Christie, Atkins, Munch-Peterson (CAMP) factor of P. acnes is a secretory protein with co-hemolytic activity with sphingomyelinase that can confer cytotoxicity to HaCaT keratinocytes and RAW264.7 macrophages. The CAMP factor from bacteria and acid sphingomyelinase (ASMase) from the host cells were simultaneously present in the culture supernatant only when the cells were co-cultured with P. acnes. Either anti-CAMP factor serum or desipramine, a selective ASMase inhibitor, significantly abrogated the P. acnes-induced cell death of HaCaT and RAW264.7 cells. Intradermal injection of ICR mouse ears with live P. acnes induced considerable ear inflammation, macrophage infiltration, and an increase in cellular soluble ASMase. Suppression of ASMase by systemic treatment with desipramine significantly reduced inflammatory reaction induced by intradermal injection with P. acnes, suggesting the contribution of host ASMase in P. acnes-induced inflammatory reaction in vivo. Vaccination of mice with CAMP factor elicited a protective immunity against P. acnes-induced ear inflammation, indicating the involvement of CAMP factor in P. acnes-induced inflammation. Most notably, suppression of both bacterial CAMP factor and host ASMase using vaccination and specific antibody injection, respectively, cooperatively alleviated P. acnes-induced inflammation. Conclusions/Significance These findings envision a novel infectious mechanism by which P. acnes CAMP factor may hijack host ASMase to amplify bacterial virulence to degrade and invade host cells. This work has identified both CAMP factor and ASMase as potential molecular targets for the development of drugs and vaccines against

  2. Practical approach to the hormonal treatment of acne.

    PubMed

    Poulin, Yves

    2004-01-01

    Acne is a disease of the pilosebaceous units and these are mainly under hormonal control. In female patients, hormonal therapy is a unique opportunity for the treatment of acne. Several combined oral contraceptives (COCs), cyproterone acetate, spironolactone, flutamide, and others, have been tried for the control of acne. An overview on the use of the most useful drugs in clinical practice was conducted. COCs are thoroughly discussed, also taking into consideration their potential side effects. A practical approach with guidelines on the use of COC in acne is proposed. PMID:15778820

  3. Review of the innate immune response in acne vulgaris: activation of Toll-like receptor 2 in acne triggers inflammatory cytokine responses.

    PubMed

    Kim, Jenny

    2005-01-01

    Acne vulgaris is a common disorder that affects 40-50 million people in the USA alone. The pathogenesis of acne is multifactorial, including hormonal, microbiological and immunological mechanisms. One of the factors that contributes to the pathogenesis of acne is Propionibacterium acnes; yet, the molecular mechanism by which P. acnes induces inflammation is not known. Recent studies have demonstrated that microbial agents trigger cytokine responses via Toll-like receptors (TLRs). TLRs are pattern recognition receptors that recognize pathogen-associated molecular patterns conserved among microorganisms and elicit immune responses. We investigated whether TLR2 mediates P. acnes-induced cytokine production in acne. Using transfectant cells we found that TLR2 was sufficient for NF-kappaB activation in response to P. acnes. In addition, peritoneal macrophages from wild-type, TLR6 knockout and TLR1 knockout mice, but not TLR2 knockout mice, produced IL-6 in response to P. acnes.P. acnes induced activation of IL-12 and IL-8 production by primary human monocytes, and this cytokine production was inhibited by anti-TLR2-blocking antibody. Finally, in acne lesions, TLR2 was expressed on the cell surface of macrophages surrounding pilosebaceous follicles. These data suggest that P. acnes triggers inflammatory cytokine responses in acne by activation of TLR2. As such, TLR2 may provide a novel target for the treatment of this common skin disease. PMID:16205063

  4. Hormonal therapy for acne.

    PubMed

    George, Rosalyn; Clarke, Shari; Thiboutot, Diane

    2008-09-01

    Acne affects more than 40 million people, of which more than half are women older than 25 years of age. These women frequently fail traditional therapy and have high relapse rates even after isotretinoin. Recent advances in research have helped to delineate the important role hormones play in the pathogenesis of acne. Androgens such as dihydrotestosterone and testosterone, the adrenal precursor dehydroepiandrosterone sulfate, estrogens, growth hormone, and insulin-like growth factors may all contribute to the development of acne. Hormonal therapy remains an important part of the arsenal of acne treatments available to the clinician. Women dealing with acne, even those without increased serum androgens, may benefit from hormonal treatments. The mainstays of hormonal therapy include oral contraceptives and antiandrogens such as spironolactone, cyproterone acetate, or flutamide. In this article, we discuss the effects of hormones on the pathogenesis of acne, evaluation of women with suspected endocrine abnormalities, and the myriad of treatment options available. PMID:18786497

  5. Acne: What's New.

    PubMed

    Stein Gold, Linda F

    2016-06-01

    Acne vulgaris is one of the most prevalent skin conditions. Antibiotics, when considered, are most effective in combination with other therapies, and limited evidence suggests that submicrobial doses of antibiotics may improve acne without increasing the risk for antibiotic resistance. A small but significant risk for inflammatory bowel disease has also been identified in children treated with multiple courses of antibiotics. New topical agents are expanding therapeutic options for acne. Semin Cutan Med Surg 35(supp6):S114-S116. PMID:27538054

  6. Oxidative Stress in Patients With Acne Vulgaris

    PubMed Central

    Arican, Ozer; Belge Kurutas, Ergul; Sasmaz, Sezai

    2005-01-01

    Acne vulgaris is one of the common dermatological diseases and its pathogenesis is multifactorial. In this study, we aim to determine the effects of oxidative stress in acne vulgaris. Forty-three consecutive acne patients and 46 controls were enrolled. The parameters of oxidative stress such as catalase (CAT), glucose-6-phosphate dehydrogenase (G6PD), superoxide dismutase (SOD), and malondialdehyde (MDA) in the venous blood of cases were measured spectrophotometrically. The values compared with control group, the relation between the severity and distribution of acne, and the correlation of each enzyme level were researched. CAT and G6PD levels in patients were found to be statistically decreased, and SOD and MDA levels were found to be statistically increased (P < .001). However, any statistical difference and correlation could not be found between the severity and distribution of lesions and the mean levels of enzymes. In addition, we found that each enzyme is correlated with one another. Our findings show that oxidative stress exists in the acne patients. It will be useful to apply at least one antioxidant featured drug along with the combined acne treatment. PMID:16489259

  7. Treatment of acne vulgaris and prevention of acne scarring: canadian consensus guidelines.

    PubMed

    Madden, W S; Landells, I D; Poulin, Y; Searles, G E; Smith, K C; Tan, J K; Toole, J; Zip, C M; Degreef, H

    2000-06-01

    Acne affects approximately 95% of the population at some point during their lifetime.1 This common disorder can range from mild to severe forms, cause sometimes extensive scarring, and can last well into the fourth and fifth decades. Effective therapeutic agents are available to both treat acne and prevent ongoing disease. Despite this, dermatologists frequently see patients with significant acne scarring because many patients delay seeking medical attention for acne and many practitioners procrastinate over using effective antiscarring options. In patients who already demonstrate scarring, repeated courses of antibiotics only result in recurring acne and additional scarring. This, in turn, exacerbates the despair and other adverse psychosocial effects of the disease. There are a variety of agents and devices to help acne patients with scarring. However, successful treatment cannot be guaranteed, and in most cases residual scarring will be evident. Thus, the most effective way of managing acne scarring is to prevent its occurrence in the first place. Although we currently have a number of effective antiacne agents to control the disease, such as antibiotics and hormonal agents, isotretinoina is the only agent that has been shown to induce long-term drug-free remission and curative potential. PMID:11749902

  8. Understanding innate immunity and inflammation in acne: implications for management.

    PubMed

    Dreno, B; Gollnick, H P M; Kang, S; Thiboutot, D; Bettoli, V; Torres, V; Leyden, J

    2015-06-01

    Acne has long been understood to have a complex physiological basis involving several main factors: hormonally-stimulated sebum production, abnormal keratinization of the pilosebaceous duct, and an inflammatory immune response to Propionibacterium acnes. Recent studies at the molecular and cellular level have begun clarifying how all of these factors interact, and the role of the innate immune system is better appreciated. Inflammation has been demonstrated in all acne lesions - the preclinical microcomedo, comedones, inflammatory lesions, 'post-inflammatory' erythema or hyperpigmentation, and scarring. Inflammation localized to the pilosebaceous unit can be considered the defining feature of acne and should be addressed via multiple therapeutic pathways. Clinicians tend to think oral antibiotics should be used to 'calm' inflammatory acne, but there is good evidence showing that topical retinoids also have anti-inflammatory properties as a class effect. For best therapeutic outcomes, most patients with acne should be treated first line with a topical retinoid plus an antimicrobial agent, as has been demonstrated in thousands of patients involved in clinical trials and recommended by the Global Alliance to Improve Outcomes in Acne for more than a decade. Moving away from reliance on antibiotic therapy for acne is particularly important in an era of worsening antimicrobial resistance and worldwide calls to reduce antibiotic use. Improved understanding about the role of P. acnes and the innate immune system in acne should help clinicians in designing efficacious treatment strategies. PMID:26059728

  9. What's new in the physiopathology of acne?

    PubMed

    Suh, D H; Kwon, H H

    2015-07-01

    There are four central factors that contribute to acne physiopathology: the inflammatory response, colonization with Propionibacterium acnes, increased sebum production and hypercornification of the pilosebaceous duct. In addition, research in the areas of diet and nutrition, genetics and oxidative stress is also yielding some interesting insights into the development of acne. In this paper we review some of the most recent research and novel concepts revealed in this work, which has been published by researchers from diverse academic disciplines including dermatology, immunology, microbiology and endocrinology. We discuss the implications of their findings (particularly in terms of opportunities to develop new therapies), highlight interrelationships between these novel factors that could contribute to the pathology of acne, and indicate where gaps in our understanding still exist. PMID:25645151

  10. Passive Immunoprotection Targeting a Secreted CAMP Factor of Propionibacterium acnes as a Novel Immunotherapeutic for Acne Vulgaris

    PubMed Central

    Liu, Pei-Feng; Nakatsuji, Teruaki; Zhu, Wenhong; Gallo, Richard L.; Huang, Chun-Ming

    2012-01-01

    Propionibacterium acnes (P. acnes) bacteria play a key role in the pathogenesis of acne vulgaris. Although our previous studies have demonstrated that vaccines targeting a surface sialidase or bacterial particles exhibit a preventive effect against P. acnes, the lack of therapeutic activities and incapability of neutralizing secretory virulence factors motivate us to generate novel immunotherapeutics. In this study, we develop an immunotherapeutic antibody to secretory Christie-Atkins-Munch-Peterson (CAMP) factor of P. acnes. Via agroinfiltration, P. acnes CAMP factor was encapsulated into the leaves of radishes. ICR mice intranasally immunized with whole leaves expressing CAMP factor successfully produced neutralizing antibodies that efficiently attenuated P. acnes-induced ear swelling and production of macrophage-inflammatory protein-2. Passive neutralization of CAMP factor enhanced immunity to eradicate P. acnes at the infection site without influencing bacterial growth elsewhere. We propose that CAMP factor is a novel therapeutic target for the treatment of various P. acnes-associated diseases and highlight the concept of neutralizing P. acnes virulence without disturbing the bacterial commensalism in human micorbiome. PMID:21354482

  11. Adolescent female acne: etiology and management.

    PubMed

    Olutunmbi, Yetunde; Paley, Kristina; English, Joseph C

    2008-08-01

    Acne vulgaris, a multifactorial condition often conferring significant psychosocial morbidity, affects an estimated 40 million people in the United States. The majority of these individuals are adolescents and young adults. The pathophysiology of the condition is still not fully known, but it is believed to be related in part to excess sebum production, follicular hyperkeratinization, microbial colonization by P acnes, and inflammation. Prior to initiating treatment in a female patient, a hyperandrogenic state must be considered and ruled out through history, physical exam, and laboratory evaluation if necessary. Treatment options are vast and include hormonal therapy among others. Hormonal therapies have long been noted to reduce acne lesions and offer a valuable adjuvant to standard therapy. Hormonal agents are thought to improve acne by blocking the androgen receptor and/or decreasing circulating androgens which leads to decreased sebum production. Hormonal treatment options include spironolactone, other antiandrogens, and oral contraceptives. The use of these agents to effectively treat acne has been demonstrated in several randomized, placebo-controlled clinical trials. Optimal results are often achieved with combination therapy with the goal of targeting multiple pathogenic pathways in acne development. PMID:18656070

  12. [Charles Bukowski's acne].

    PubMed

    Bahmer, F A; Bahmer, J A

    2012-04-01

    In his autobiography, Charles Bukowski (1920-1994) describes his severe acne conglobata, his experience with therapy, family conflicts and emotional tension. Despite the stigmatization by his acne scars, Bukowski became a philobatic writer and a true chronist of the American way of life in the second half of the 20th century, writing in a coarse and obscene language. PMID:22406763

  13. Postadolescent acne in females.

    PubMed

    Holzmann, R; Shakery, K

    2014-01-01

    Acne in the adult female often presents as a chronic condition that can have a considerable negative psychological, social and emotional impact on the affected individual. Estimated prevalence rates of adult female acne vary widely according to study type. Case reports and clinical examinations estimate the prevalence of clinical acne at 10-12%, while survey estimates of physiological disease states are as high as 54%. Two subtypes of adult female acne may be defined according to time of onset: 'persistent' and 'late-onset', accounting for approximately 80 and 20% of cases, respectively. Postadolescent acne is generally mild-to-moderate in severity and presents with more inflammatory lesions and fewer comedones compared to adolescent acne. Furthermore, the impact of acne on the quality of life is often greater in adult females than in younger individuals. Despite these important differences, the key principles of acne treatment in the adult female do not differ significantly from those of other age groups. However, specific characteristics relating to the adult female should be considered when selecting a treatment regimen. PMID:24280643

  14. Hormonal therapies in acne.

    PubMed

    Shaw, James C

    2002-07-01

    Hormones, in particular androgen hormones, are the main cause of acne in men, women, children and adults, in both normal states and endocrine disorders. Therefore, the use of hormonal therapies in acne is rational in concept and gratifying in practice. Although non-hormonal therapies enjoy wide usage and continue to be developed, there is a solid place for hormonal approaches in women with acne, especially adult women with persistent acne. This review covers the physiological basis for hormonal influence in acne, the treatments that are in use today and those that show promise for the future. The main treatments to be discussed are oral contraceptives androgen receptor blockers like spironolactone and flutamide, inhibitors of the enzyme 5 alpha-reductase and topical hormonal treatments. PMID:12083987

  15. Evaluation and Management of Acne.

    PubMed

    Botros, Paul A; Tsai, Gary; Pujalte, George G A

    2015-12-01

    Acne is a common complaint in the primary care clinics. It has not only physical implications but also psychological. This article discusses the epidemiology, pathophysiology, and criteria for making the diagnosis. It also discusses endocrine disorders that may be the cause of acne. Treatment and management are discussed by subtype. Acne mechanica or sports-related acne is also discussed. PMID:26612368

  16. Acne: more than skin deep

    PubMed Central

    Ayer, J; Burrows, N

    2006-01-01

    Acne is one of the most prevalent skin conditions affecting teenagers. It is a disease of the pilosebaceous unit. Blockage of sebaceous glands and colonisation with Proionobacterium acnes leads to acne. Grading the severity of acne helps to determine the appropriate treatment. Treatment of acne should be started as early as possible to minimise the risk of scarring and adverse psychological effects. It should be tailored to the individual patient, the type of acne, its severity, the patient's ability to use the treatment, and the psychological state. Topical agents are the mainstay for treatment of mild acne. Moderate acne is treated with oral antibiotics. Resistance to antibiotics may be reduced by subsequent use of non‐antibiotic topical medications. Severe acne is treated with isotretinoin, and this can lead to permanent remission. With better education and care given by medical profession, acne treatment could be significantly improved. PMID:16891439

  17. Nanoparticle Stabilized Liposomes for Acne Therapy

    NASA Astrophysics Data System (ADS)

    Fu, Victoria

    Acne vulgaris is a common skin disease that affects over 40 million people in the United States alone. The main cause of acne vulgaris is Propionibacterium acnes (P. acnes), resides deep in the pores and follicles of the skin in order to feed on oil produced by the sebaceous glands. The liposome is a lipid based nanoparticle with numerous advantages over free drug molecules as an acne treatment alternative. Bare liposomes loaded with lauric acid (LipoLA) were found to show strong antimicrobial activity against P. acnes while generating minimal toxicity. However, the platform is limited by the spontaneous tendency of liposomes to fuse with each other. Attaching nanoparticles to the surface of liposomes can overcome this challenge by providing steric repulsion and reduce surface tension. Thus, carboxyl-functionalized gold nanoparticles (AuC) were attached to the surface of liposomes (AuC-liposomes) loaded with doxycycline, a general tetracycline antibiotic. These particles were found to have a diameter of 120 nm and a zeta potential of 20.0 mV. Both fluorescent and antimicrobial studies demonstrated that based on electrostatic interaction, negatively charged AuC attached to the liposome's positively charged surface and stabilized liposomes in a neutral pH environment (pH = 7.4). Upon entering the skin's acidic environment (pH = 4), AuC detached from the liposome's surface and liposomes could fuse with P. acnes residing in the pores. Furthermore, toxicity studies showed that AuC-liposomes did not induce any significant toxicity, while two of the leading over-the-counter therapies, benzoyl peroxide and salicylic acid, generated substantial skin irritation.

  18. Investigating the Stability of Benzoyl Peroxide in Over-the-Counter Acne Medications

    ERIC Educational Resources Information Center

    Kittredge, Marina Canepa; Kittredge, Kevin W.; Sokol, Melissa S.; Sarquis, Arlyne M.; Sennet, Laura M.

    2008-01-01

    One of the most commonly used ingredients in over-the-counter acne treatments in cream, gel, and wash form is benzoyl peroxide. It is an anti-bacterial agent that kills the bacterium ("Propionibacterium acne") involved in the formation of acne. The formulation of these products is extremely difficult owing to the instability of benzoyl peroxide.…

  19. Treatment of acne scarring.

    PubMed

    Alam, M; Dover, J S

    Acne scarring is common but surprisingly difficult to treat. Scars can involve textural change in the superficial and deep dermis, and can also be associated with erythema, and less often, pigmentary change. In general, treatment of acne scarring is a multistep procedure. First, examination of the patient is necessary to classify the subtypes of scarring that are present. Then, the patient's primary concerns are elicited, and the patient is offered a menu of procedures that may address the various components of the scarring process. It is important to emphasize to the patient that acne scarring can be improved but never entirely reversed. PMID:17180246

  20. Antiandrogen and hormonal treatment of acne.

    PubMed

    Shaw, J C

    1996-10-01

    In the treatment of acne in women, the use of antiandrogens and other hormonal approaches is a valuable alternative to standard therapy. These treatments that are based on physiologically sound principles produce gratifying results in selected women with acne, and are the primary treatment for women with hirsutism. The drugs discussed in this article include spironolactone, cyproterone acetate, flutamide, oral contraceptives, corticosteroids, finasteride, and gonadotropin-releasing hormone agonists. Patient selection, pretreatment evaluation, and case studies also are discussed with an emphasis on practical applications. PMID:9238337

  1. [How I treat... acne by isotretinoin].

    PubMed

    Piérard-Franchimont, C; Nikkels, A F; Piérard, G E

    2008-03-01

    Acne benefits from a series of treatments. The introduction of isotretinoin was a therapeutic breakthrough which considerably improved both the evolution and the prognosis of the disease. Indications of this retinoid kept changing over the past twenty years. New clinical conditions emerged including the management of disease recurrences. The daily dosages must be selected according to the type of acne, the gender of the patient and the pharmaco-economical implications. Teratogenicity must never be neglected as it represents the dreadful adverse event of the drug. A European Directive currently marks out the way to use this retinoid. PMID:18561765

  2. Antibiotic-resistant acne: getting under the skin.

    PubMed

    Sinha, Mau; Sadhasivam, Suresh; Bhattacharyya, Anamika; Jain, Shilpi; Ghosh, Shamik; Arndt, Kenneth A; Dover, Jeffrey S; Sengupta, Shiladitya

    2016-06-01

    Propionibacterium acnes is a key pathogenic factor in the development of acne. Antibiotics are the first choice of treatment for mild-to-moderate, mixed, papular/pustular, and moderate nodular acne, and an alternative choice in severe, nodular/conglobate acne. The emergence of resistance to the currently available antibiotics poses a serious set-back to this algorithm, and the reduced arsenal can diminish efficacy of treatment. This emerging situation should catalyze innovations in dermatology; for example, newer drugs and technologies such as next-generation antibiotics with excellent potency and low propensity to develop resistance, rapid diagnostic platforms to select responders and nonresponders, and delivery technologies that target the bacteria. Such innovations can dramatically expand the arsenal for dermatologists in the management of acne. PMID:27416310

  3. Antiandrogenic Therapy with Ciproterone Acetate in Female Patients Who Suffer from Both Androgenetic Alopecia and Acne Vulgaris

    PubMed Central

    CONEAC, ANDREI; MURESAN, ADRIANA; ORASAN, MEDA SANDRA

    2014-01-01

    Background. Androgenetic Alopecia in Women (AGA) occurs due to an underlying susceptibility of hair follicles to androgenic miniaturization, caused by androgens. Clinically, AGA is characterized by progressive hair loss, with a marked hair thinning in the fronto-parietal area so that the scalp can be easily seen. Acne vulgaris is androgen-dependent and often affects the skin that has an increased number of oil glands: face, back and chest. Although the sebaceous glands are present on the scalp too, it is very rare to get acne at this site, as the hair acts as a wig and allows the sebum to drain and does not block the pores. Both AGA and Acne Vulgaris are signs of hyperandrogenism. Cyproterone acetate/ethinyl estradiol (2mg/0.035mg) products are authorized for the treatment of androgenetic symptoms in women, such as acne, seborrhea, mild forms of hirsutism and androgenetic alopecia. Our study had a double purpose: - To evaluate the result of the study regimen Melleva 35 (one pill per day, for 3 consecutive months) in patients with moderate to severe acne, suffering also from Androgenetic Alopecia;- To establish the efficacy of the drug on acne and alopecia improvement, both from the doctor’s and patient’s point of view. Patients and methods. After being informed of the aims and procedures of the study, participants provided a written informed consent. A number of 35 female subjects with moderate to severe acne vulgaris remained in the study. The subjects had also been diagnosed as suffering from AGA, on the basis of clinical criteria, including the pattern of hair loss and trichoscopy assessment. Results 83% of study subjects reported that their hair did not continue to fall after 3 months of antiandrogen therapy. The females were evaluated using trichoscopy and the doctor noticed hair regrowth in 77% of the cases. Regarding the improvement of acne lesions after the treatment, 40% of study subjects recorded good improvement and 26% recorded excellent results

  4. Teens and Acne Treatment

    MedlinePlus

    ... Types of treatments Benzoyl peroxide Benzoyl peroxide wash, lotion, or gel—the most effective acne treatment you ... and make it redder than the wash or lotion, so try the wash or lotion first. How ...

  5. Bacteriophages Infecting Propionibacterium acnes

    PubMed Central

    2013-01-01

    Viruses specifically infecting bacteria, or bacteriophages, are the most common biological entity in the biosphere. As such, they greatly influence bacteria, both in terms of enhancing their virulence and in terms of killing them. Since the first identification of bacteriophages in the beginning of the 20th century, researchers have been fascinated by these microorganisms and their ability to eradicate bacteria. In this review, we will cover the history of the Propionibacterium acnes bacteriophage research and point out how bacteriophage research has been an important part of the research on P. acnes itself. We will further discuss recent findings from phage genome sequencing and the identification of phage sequence signatures in clustered regularly interspaced short palindromic repeats (CRISPRs). Finally, the potential to use P. acnes bacteriophages as a therapeutic strategy to combat P. acnes-associated diseases will be discussed. PMID:23691509

  6. Acne - self-care

    MedlinePlus

    ... Clean your skin gently with a mild, non-drying soap, such as Dove, Neutrogena, Cetaphil, or CeraVe. ... of your face. Acne medicines can cause skin drying or peeling. Use a moisturizer or skin cream ...

  7. An innovative approach to the topical treatment of acne.

    PubMed

    Sparavigna, Adele; Tenconi, Beatrice; De Ponti, Ileana; La Penna, Laura

    2015-01-01

    Acne is characterized by primary lesions on the face, chest, and back, and by a variety of other signs and symptoms. In particular, acne inflammatory lesions result from Propionibacterium acnes colonization and are of particular relevance as they can cause permanent scarring. Acne also causes significant psychological morbidity in affected patients. Products currently available for the treatment of acne include systemic and topical treatments. As these products can cause severe side effects, new, innovative therapies are needed. Farmaka Acne Cream (FAC) is a novel, film-forming cream developed to treat mild and moderate acne. In vitro studies have demonstrated that FAC is as effective as 5% benzoyl peroxide in inhibiting growth of P. acnes. In 32 subjects with mild or moderate acne, FAC reduced all the major signs and symptoms of the disease. These included itching, erythema, and scaling, as well as reductions in the numbers of papules, pustules, and open and closed comedones. Acne severity improved in 38% of subjects, while none worsened. FAC was found to be effective in controlling sebum secretion, and was non-comedogenic. Most subjects (90%) reported tolerability as good or very good, while clinical efficacy and cosmetic acceptability were judged as good. For assessment of contact sensitization and photosensitization, FAC was applied daily to the backs of 29 subjects in two symmetric areas for 10 days. Using a solar stimulator, one minimal erythema dose was delivered to one side of the back from days 11 to 13. The four different subareas of treated/untreated and irradiated/nonirradiated and combinations thereof were compared. No cases of contact sensitization or photosensitization were observed, and FAC is considered safe for use in intense sunlight. In vitro and in vivo studies provide evidence for the safety and clinical benefits of FAC, a promising candidate for the treatment of mild and moderate acne. PMID:25914552

  8. An innovative approach to the topical treatment of acne

    PubMed Central

    Sparavigna, Adele; Tenconi, Beatrice; De Ponti, Ileana; La Penna, Laura

    2015-01-01

    Acne is characterized by primary lesions on the face, chest, and back, and by a variety of other signs and symptoms. In particular, acne inflammatory lesions result from Propionibacterium acnes colonization and are of particular relevance as they can cause permanent scarring. Acne also causes significant psychological morbidity in affected patients. Products currently available for the treatment of acne include systemic and topical treatments. As these products can cause severe side effects, new, innovative therapies are needed. Farmaka Acne Cream (FAC) is a novel, film-forming cream developed to treat mild and moderate acne. In vitro studies have demonstrated that FAC is as effective as 5% benzoyl peroxide in inhibiting growth of P. acnes. In 32 subjects with mild or moderate acne, FAC reduced all the major signs and symptoms of the disease. These included itching, erythema, and scaling, as well as reductions in the numbers of papules, pustules, and open and closed comedones. Acne severity improved in 38% of subjects, while none worsened. FAC was found to be effective in controlling sebum secretion, and was non-comedogenic. Most subjects (90%) reported tolerability as good or very good, while clinical efficacy and cosmetic acceptability were judged as good. For assessment of contact sensitization and photosensitization, FAC was applied daily to the backs of 29 subjects in two symmetric areas for 10 days. Using a solar stimulator, one minimal erythema dose was delivered to one side of the back from days 11 to 13. The four different subareas of treated/untreated and irradiated/nonirradiated and combinations thereof were compared. No cases of contact sensitization or photosensitization were observed, and FAC is considered safe for use in intense sunlight. In vitro and in vivo studies provide evidence for the safety and clinical benefits of FAC, a promising candidate for the treatment of mild and moderate acne. PMID:25914552

  9. [Amineptin dependence and iatrogenic acne. Review of the literature apropos of a case].

    PubMed

    Duriot, J F; Dutertre, J P; Grenier, J M; Autret, A; Martin, A

    1991-12-01

    We relate the case of a drug addict of 31 years old whose dependence to the amineptine got complicated with severe acne-like lesions, as it sometimes happens. Compared, with teenage acne, severe acne can be distinguished by its late out break, its monstrous nature and its larger surface area. Amineptine has been found (or its metabolites) in the plasma, the urine. The treatment consists in the stopping of the drug addiction, combined with the prescription of isotretinoin. PMID:1839203

  10. Acne and the Internet.

    PubMed

    Zeichner, Joshua A; Del Rosso, James Q

    2016-04-01

    The Internet provides both education and miseducation for acne patients. Although some sites provide disease background information and objective treatment guidance, support networks, and research findings, others may seem to be objective on the surface, but are in reality run by untrained, self-proclaimed experts or are promotional in nature. Providers must be aware of the potential benefits and pitfalls the Internet provides for those suffering with acne. PMID:27015772

  11. Raman Barcode for Counterfeit Drug Product Detection.

    PubMed

    Lawson, Latevi S; Rodriguez, Jason D

    2016-05-01

    Potential infiltration of counterfeit drug products-containing the wrong or no active pharmaceutical ingredient (API)-into the bona fide drug supply poses a significant threat to consumers worldwide. Raman spectroscopy offers a rapid, nondestructive avenue to screen a high throughput of samples. Traditional qualitative Raman identification is typically done with spectral correlation methods that compare the spectrum of a reference sample to an unknown. This is often effective for pure materials but is quite challenging when dealing with drug products that contain different formulations of active and inactive ingredients. Typically, reliable identification of drug products using common spectral correlation algorithms can only be made if the specific product under study is present in the library of reference spectra, thereby limiting the scope of products that can be screened. In this paper, we introduce the concept of the Raman barcode for identification of drug products by comparing the known peaks in the API reference spectrum to the peaks present in the finished drug product under study. This method requires the transformation of the Raman spectra of both API and finished drug products into a barcode representation by assigning zero intensity to every spectral frequency except the frequencies that correspond to Raman peaks. By comparing the percentage of nonzero overlap between the expected API barcode and finished drug product barcode, the identity of API present can be confirmed. In this study, 18 approved finished drug products and nine simulated counterfeits were successfully identified with 100% accuracy utilizing this method. PMID:27043140

  12. Treatment Modalities for Acne.

    PubMed

    Fox, Lizelle; Csongradi, Candice; Aucamp, Marique; du Plessis, Jeanetta; Gerber, Minja

    2016-01-01

    Acne is a common inflammatory skin disease which affects the pilosebaceous units of the skin. It can have severe psychological effects and can leave the patient with severe skin scarring. There are four well-recognized pathological factors responsible for acne which is also the target for acne therapy. In this review, different treatment options are discussed, including topical (i.e., retinoids, and antibiotics) and systemic (i.e., retinoids, antibiotics, and hormonal) treatments. Since the general public has been showing an increasing interest in more natural and generally safer treatment options, the use of complementary and alternative medicines (CAM) for treating acne was also discussed. The use of physical therapies such as comedone extraction, cryoslush therapy, cryotherapy, electrocauterization, intralesional corticosteroids and optical treatments are also mentioned. Acne has been extensively researched with regards to the disease mechanism as well as treatment options. However, due to the increasing resistance of Propionibacterium acnes towards the available antibiotics, there is a need for new treatment methods. Additionally, the lack of necessary evidence on the efficacy of CAM therapies makes it necessary for researchers to investigate these treatment options further. PMID:27529209

  13. Acne and diet.

    PubMed

    Wolf, Ronni; Matz, Hagit; Orion, Edith

    2004-01-01

    Forbidden foods? "The first law of dietetics seems to be: If it tastes good, it's bad for you" (Isaac Asimov, Russian-born biochemist and science fiction writer). This was essentially the Magna Carta for dermatologists of the 1950s: anything coveted by the teenage palate was suspect for morning after acne. Today, half a century later, although the slant has shifted away for this line of thinking in our dermatologic textbooks, several articles on the beliefs and perceptions of acne patients showed that nothing much has changed and that they expect us to give them detailed instructions of what "acne-related" foods they should avoid. In one such study(1), diet was the third most frequently implicated factor (after hormones and genetics) as the cause of the disease, with 32% of the respondents selecting diet as the main cause, and 44% thinking that foods aggravate acne. In another study that analyzed knowledge about causes of acne among English teenagers, 11% of the responders blamed greasy food as the main cause of the disease(2), whereas in another study found that 41% of final-year medical students of the University of Melbourne chose diet as an important factor of acne exacerbation on a final examination.(3) PMID:15556724

  14. Rosmarinus officinalis extract suppresses Propionibacterium acnes-induced inflammatory responses.

    PubMed

    Tsai, Tsung-Hsien; Chuang, Lu-Te; Lien, Tsung-Jung; Liing, Yau-Rong; Chen, Wei-Yu; Tsai, Po-Jung

    2013-04-01

    Propionibacterium acnes is a key pathogen involved in the progression of acne inflammation. The development of a new agent possessing antimicrobial and anti-inflammatory activity against P. acnes is therefore of interest. In this study, we investigated the inhibitory effect of rosemary (Rosmarinus officinalis) extract on P. acnes-induced inflammation in vitro and in vivo. The results showed that ethanolic rosemary extract (ERE) significantly suppressed the secretion and mRNA expression of proinflammatory cytokines, including interleukin (IL)-8, IL-1β, and tumor necrosis factor-α in P. acnes-stimulated monocytic THP-1 cells. In an in vivo mouse model, concomitant intradermal injection of ERE attenuated the P. acnes-induced ear swelling and granulomatous inflammation. Since ERE suppressed the P. acnes-induced nuclear factor kappa-B (NF-κB) activation and mRNA expression of Toll-like receptor (TLR) 2, the suppressive effect of ERE might be due, at least partially, to diminished NF-κB activation and TLR2-mediated signaling pathways. Furthermore, three major constituents of ERE, carnosol, carnosic acid, and rosmarinic acid, exerted different immumodulatory activities in vitro. In brief, rosmarinic acid significantly suppressed IL-8 production, while the other two compounds inhibited IL-1β production. Further study is needed to explore the role of bioactive compounds of rosemary in mitigation of P. acnes-induced inflammation. PMID:23514231

  15. Cleansing and moisturizing in acne patients.

    PubMed

    Goodman, Greg

    2009-01-01

    Affecting over 80% of adolescents, acne is a widespread condition with substantial negative physical and emotional effects, and significant societal cost. Cleansing the acne patient involves several considerations, including matching skin type to the right type of cleanser, optimal times and methods of cleansing, treating parts of the body other than the face, and patient perceptions of the cause and treatment of acne. Moisturizing prevents and alleviates skin irritation, soothing the skin by slowing the evaporation of water. Many liquid face cleansers also moisturize, which may be all that is needed for a patient with oily skin. Protection from sun and environmental damage is important for all patients. While sunscreens are often irritants, the best options for young, oily, acne-prone skin tend to have a water or light liquid base. Moisturizing sunscreens are appropriate for patients with dry, sun-damaged skin, as well as those who wear makeup, have other skin diseases, or are easily irritated by products. Overall, treating acne patients should include education in patient-friendly terms and promoting healthy daily skin care practices, including cleansing and protection against environmental damage. PMID:19209947

  16. Update and future of hormonal therapy in acne.

    PubMed

    Thiboutot, Diane; Chen, WenChieh

    2003-01-01

    Hormonal therapy is an important component in the treatment of women with acne who may or may not have elevated serum androgens. The mainstays of hormonal therapy include oral contraceptives and antiandrogens such as cyproterone acetate, flutamide or spironolactone. Recent research over the past several years has unraveled some of the details regarding the way that the skin and sebaceous glands synthesize and metabolize hormones. The knowledge gained from this work may provide an impetus for future drug discovery in the hormonal treatment of acne and lead to improvements in the care of our patients with acne. PMID:12566806

  17. Misconceptions about Acne Still Common

    MedlinePlus

    ... gov/medlineplus/news/fullstory_157613.html Misconceptions About Acne Still Common Skin condition isn't caused by ... of negative and mistaken beliefs about people with acne, a new study finds. Researchers showed photos of ...

  18. Acne neonatorum and familial hyperandrogenism.

    PubMed

    Bekaert, C; Song, M; Delvigne, A

    1998-01-01

    We report a case of acne neonatorum developed in a boy since birth. His mother and his aunt had different signs of hyperandrogenism including acne and hirsutism. This case illustrates the correlation between acne neonatorum and familial hyperandrogenism. It shows the importance of the family history and the eventual clinical and serological presence of hyperandrogenism in the mother when confronted with acne neonatorum. PMID:9669129

  19. Targeted delivery of salicylic acid from acne treatment products into and through skin: role of solution and ingredient properties and relationships to irritation.

    PubMed

    Rhein, Linda; Chaudhuri, Bhaskar; Jivani, Nur; Fares, Hani; Davis, Adrian

    2004-01-01

    Salicylic acid (SA) is a beta hydroxy acid and has multifunctional uses in the treatment of various diseases in skin such as acne, psoriasis, and photoaging. One problem often cited as associated with salicylic acid is that it can be quite irritating at pH 3-4, where it exhibits the highest activity in the treatment of skin diseases. We have identified strategies to control the irritation potential of salicylic acid formulations and have focused on hydroalcoholic solutions used in acne wipes. One strategy is to control the penetration of SA into the skin. Penetration of the drug into various layers of skin, i.e., epidermis, dermis, and receptor fluid, was measured using a modified Franz in vitro diffusion method after various exposure times up to 24 hours. A polyurethane polymer (polyolprepolymer-15) was found to be an effective agent in controlling delivery of SA. In a dose-dependent fashion it targeted delivery of more SA to the epidermis as compared to penetration through the skin into the receptor fluid. It also reduced the rapid rate of permeation of a large dose of SA through the skin in the first few hours of exposure. A second strategy that proved successful was incorporation of known mild nonionic surfactants like isoceteth-20. These surfactants cleanse the skin, yet due to their inherent mildness (because of their reduced critical micelle concentration and monomer concentration), keep the barrier intact. Also, they reduce the rate of salicylic acid penetration, presumably through micellar entrapment (either in solution or on the skin surface after the alcohol evaporates). Cumulative irritation studies showed that targeting delivery of SA to the epidermis and reducing the rapid early rate of penetration of large amounts of drug through the skin resulted in a reduced irritation potential. In vivo irritation studies also showed that the surfactant system is the most important factor controlling irritancy. SA delivery is secondary, as formulations with less

  20. Development of stable lyophilized protein drug products.

    PubMed

    Remmele, Richard L; Krishnan, Sampathkumar; Callahan, William J

    2012-03-01

    Freeze drying, or lyophilization is widely used for biopharmaceuticals to improve the long term storage stability of labile molecules. This review examines general theory and practice of rational lyophilization of biopharmaceuticals. Formulation development involving the selection of appropriate excipients, their associated physical properties, and mechanism of action in achieving a stable drug product are primary considerations for a successful lyophilization program. There are several parameters considered critical on the basis of their relationship to lyophilization cycle development and protein product stability. This along with the importance of analytical methods to provide insight toward understanding properties of drug product stability and cake structure are discussed. Also, aspects of instability found in lyophilized biopharmaceutical products, their degradation pathways and control are elucidated. Finally, container-closure requirements and drug product handling are described in context of the caveats to avoid compromising drug product quality. PMID:22283723

  1. 21 CFR 355.50 - Labeling of anticaries drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of anticaries drug products. 355.50 Section 355.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 355.50 Labeling of anticaries drug products....

  2. Enzymatic and hemolytic properties of Propionibacterium acnes and related bacteria.

    PubMed

    Hoeffler, U

    1977-12-01

    The production of chondroitin sulfatase, hyaluronidase, deoxyribonuclease, gelatinase, phosphatase, lecithinase, and hemolysins was examined in 95 strains of Propionibacterium acnes and four related species of anaerobic, respectively, microaerophilic coryneform bacteria (P. avidum, P. lymphophilum, P. granulosum, and Corynebacterium minutissimum). All enzymes could be demonstrated in at least one representative of the species tested. Those Propionibacterium species most frequently found in acne vulgaris lesions, i.e., P. acnes and P. granulosum, proved to be the most active organisms concerning the production of the enzymes tested. P. avidum, on the other hand, showed the highest rate of hemolytic activity. PMID:201661

  3. Induction of proinflammatory cytokines by a soluble factor of Propionibacterium acnes: implications for chronic inflammatory acne.

    PubMed

    Vowels, B R; Yang, S; Leyden, J J

    1995-08-01

    Although many cytokines have been implicated in the development and persistence of inflammatory immune responses, it is unknown if any of these are important in inflammatory acne. This study investigated the production of the proinflammatory cytokines interleukin-8 (IL-8), IL-1 beta, and tumor necrosis factor alpha (TNF-alpha) by human monocytic cell lines, ThP-1 and U937, and by freshly isolated peripheral blood mononuclear cells from acne patients. Both Propionibacterium acnes and supernatants obtained from 72-h P. acnes cultures could induce significant concentrations of IL-1 beta, TNF-alpha, and IL-8 by both cell lines and by peripheral blood mononuclear cells as determined by enzyme-linked immunosorbent assay. There was no significant difference between acne and non-acne subjects. Endotoxin quantification and addition of polymyxin B to assays indicated no lipopolysaccharide (LPS) contamination. P. acnes supernatant was fractionated into components with molecular weights of < 3,000, < 10,000, and < 30,000 and assayed for the ability to induce IL-8 and TNF production in ThP-1 cells. Nearly 90% of the original activity was found in the < 30,000-molecular-weight fraction, 50% was in the < 10,000-molecular-weight fraction, and only 15% remained in the < 3,000-molecular-weight fraction. The effluent from the < 3,000-molecular-weight fraction contained about 70% activity, indicating that the inducing factor was not retained in the membrane. Incubation of P. acnes supernatant with various concentrations of mutanolysin or lysozyme resulted in a loss of 60% of the original activity. The addition of jimson lectin, which binds peptidoglycan, resulted in a loss of 70% of the activity in a dose-response manner, whereas peanut lectin had little or no effect on the activity. Heating of the P. acnes supernatant to 65 degrees C also had no effect on the activity. Blocking of CD14, a receptor for both LPS and peptidoglycan, reduced cytokine production by > 50%, suggesting that

  4. 21 CFR 211.134 - Drug product inspection.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during...

  5. 21 CFR 211.134 - Drug product inspection.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during...

  6. 21 CFR 211.134 - Drug product inspection.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during...

  7. 21 CFR 211.134 - Drug product inspection.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... § 211.134 Drug product inspection. (a) Packaged and labeled products shall be examined during...

  8. 21 CFR 332.30 - Labeling of antiflatulent drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of antiflatulent drug products. 332.30 Section 332.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 332.30 Labeling of antiflatulent drug products....

  9. Counting on natural products for drug design

    NASA Astrophysics Data System (ADS)

    Rodrigues, Tiago; Reker, Daniel; Schneider, Petra; Schneider, Gisbert

    2016-06-01

    Natural products and their molecular frameworks have a long tradition as valuable starting points for medicinal chemistry and drug discovery. Recently, there has been a revitalization of interest in the inclusion of these chemotypes in compound collections for screening and achieving selective target modulation. Here we discuss natural-product-inspired drug discovery with a focus on recent advances in the design of synthetically tractable small molecules that mimic nature's chemistry. We highlight the potential of innovative computational tools in processing structurally complex natural products to predict their macromolecular targets and attempt to forecast the role that natural-product-derived fragments and fragment-like natural products will play in next-generation drug discovery.

  10. From new findings in acne pathogenesis to new approaches in treatment.

    PubMed

    Gollnick, H P M

    2015-06-01

    Acne is a chronic disease of the pilosebaceous unit which is most common during adolescence. Four factors are believed to play a key role in the development of acne lesions: excess sebum production, disturbed keratinization within the follicle, colonization of the pilosebaceous duct by Propionibacterium acnes, and the release of inflammatory mediators into the skin. Consequently, in order to effectively and rapidly reduce acne lesions, treatments need to address as many of these underlying factors as possible. Currently, about half of patients have poor adherence to acne treatments. To overcome this limitation, treatments need to be developed which are well tolerated by patients, and easy for them to use, handle and apply. Topical monotherapies for acne such as retinoids and antimicrobials by themselves have a restricted range of actions against the pathogenic factors of acne. Instead, the Global Alliance to Improve Outcomes in Acne Group recommends combination therapy with a topical retinoid and an antimicrobial agent as the preferred approach for almost all acne patients. The principal advantage of such combinations is that they target more of the underlying pathogenic factors of acne than individual monotherapies and this results in faster and more complete clearing of acne lesions. Fixed-dose combinations are also more convenient than applying two medications separately, which leads to improved adherence with the regimen. By normalizing desquamation, the retinoid component of these combinations allows entry of the antimicrobial agent into the pilosebaceous unit resulting in faster clearance of P. acnes. In conclusion, topical retinoid/antimicrobial fixed-dose combinations represent a rational approach for the treatment of acne. They should be considered as the cornerstone of acne management and should be used much more in the future. PMID:26059819

  11. 21 CFR 352.52 - Labeling of sunscreen drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of sunscreen drug products. 352.52... (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 352.52 Labeling of sunscreen drug products. (a) Statement of identity. The labeling of the product contains...

  12. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product containers and closures. 211.94... Components and Drug Product Containers and Closures § 211.94 Drug product containers and closures. (a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the...

  13. Dietary intervention in acne

    PubMed Central

    Melnik, Bodo

    2012-01-01

    The purpose of this paper is to highlight the endocrine signaling of Western diet, a fundamental environmental factor involved in the pathogenesis of epidemic acne. Western nutrition is characterized by high calorie uptake, high glycemic load, high fat and meat intake, as well as increased consumption of insulin- and IGF-1-level elevating dairy proteins. Metabolic signals of Western diet are sensed by the nutrient-sensitive kinase, mammalian target of rapamycin complex 1 (mTORC1), which integrates signals of cellular energy, growth factors (insulin, IGF-1) and protein-derived signals, predominantly leucine, provided in high amounts by milk proteins and meat. mTORC1 activates SREBP, the master transcription factor of lipogenesis. Leucine stimulates mTORC1-SREBP signaling and leucine is directly converted by sebocytes into fatty acids and sterols for sebaceous lipid synthesis. Over-activated mTORC1 increases androgen hormone secretion and most likely amplifies androgen-driven mTORC1 signaling of sebaceous follicles. Testosterone directly activates mTORC1. Future research should investigate the effects of isotretinoin on sebocyte mTORC1 activity. It is conceivable that isotretinoin may downregulate mTORC1 in sebocytes by upregulation of nuclear levels of FoxO1. The role of Western diet in acne can only be fully appreciated when all stimulatory inputs for maximal mTORC1 activation, i.e., glucose, insulin, IGF-1 and leucine, are adequately considered. Epidemic acne has to be recognized as an mTORC1-driven disease of civilization like obesity, type 2 diabetes, cancer and neurodegenerative diseases. These new insights into Western diet-mediated mTORC1-hyperactivity provide a rational basis for dietary intervention in acne by attenuating mTORC1 signaling by reducing (1) total energy intake, (2) hyperglycemic carbohydrates, (3) insulinotropic dairy proteins and (4) leucine-rich meat and dairy proteins. The necessary dietary changes are opposed to the evolution of

  14. [Use of organic acids in acne and skin discolorations therapy].

    PubMed

    Kapuścińska, Alicja; Nowak, Izabela

    2015-01-01

    Acne is one of the most frequent skin disorders that occurs in puberty, but often adults also have acne. The most important factors responsible for acne are elevated production of sebum by hyperactive sebaceous glands and blockage of the follicle because of hyperkeratosis [14]. The third etiopathogenic factor of acne is excessive microflora reproduction [8]. The most significant bacterium that is responsible for formation of skin lesions is Propionibacterium acnes, a rod-shaped Gram-positive and aerotolerant anaerobic bacterium. It is estimated that P. acnes is responsible for acne in approximately 80% of people aged 11 to 30 [27,40]. Even healed skin lesions can often cause skin discolorations and scar formation [51]. Exfoliating chemical substances that are commonly used in dermatology and cosmetology are organic acids. Exfoliating treatment using organic acids is called "chemical peeling" and consists of controlled application of those substances on the skin [38]. The depth of exfoliation depends on organic acid concentration, type of substance and contact time with the skin [41]. Using exfoliating agents seems to be helpful in excessive keratinization - one of several factors responsible for acne. Moreover, epidermis exfoliation is a popular method of removing skin discoloration [22]. Considering chemical structure, exfoliating substances that are most often used in cosmetology contain alpha-hydroxyacids (glycolic acid, lactic acid, mandelic acid and citric acid), beta-hydroxyacids (salicylic acid) and other organic acids, such as trichloroacetic acid and pyruvic acid [47]. In this article, a literature review of use of organic acids in acne and skin discoloration therapy is presented. PMID:25811473

  15. Pharmaceutical development of microbicide drug products.

    PubMed

    Friend, David R

    2010-12-01

    HIV infection rates in the developing world remain a serious problem. One potential approach to reduce infection rates is to use products known as microbicides, referred to herein as microbicide drug products (MDPs). These are drugs capable of, when administered topically to the vagina (or rectum), interfering with infection by one or more mechanisms. This review article covers the latest pharmaceutical developments in the area of microbicides dosage forms and delivery systems. These products are principally designed for use in the developing world and must therefore address cultural and societal issues generally unknown in the developed world. The first-generation microbicides evaluated clinically were principally polyanions. These drugs, administered intravaginally as gels, were found to be ineffective in preventing transmission of HIV from men to women. Second-generation drugs such as tenofovir, dapivirine, and UC781 are reverse transcriptase inhibitors developed as gels formulations and intravaginal rings (IVRs). Gels are considered coitally-related products while IVRs are coitally-independent systems designed to release the drug over a four-week period or possibly longer (up to 3 or 4 months). Other dosage forms under development include fast dissolving films, tablets/capsules, and possibly vaginal sponges. Dual protection systems are also under development. These systems include formulations capable of preventing HIV infection along with a second drug capable of preventing conception or other viral infections such as HSV. PMID:20017601

  16. Perimenstrual Flare of Adult Acne

    PubMed Central

    Geller, Lauren; Rosen, Jamie; Frankel, Amylynne; Goldenberg, Gary

    2014-01-01

    Background: Acne is typically regarded as an adolescent disease. A significant body of literature suggests a post-adolescent or adult form of acne. Female patients are known to experience perimenstrual acne flares, the exact prevalence of which is unknown. Objective: To establish a pattern of perimenstrual acne flare in adult women in order to better characterize the disorder. Methods: Subjects aged 18 and over were recruited during previously scheduled visits with their dermatologist at Mount Sinai Hospital in New York. An anonymous survey was distributed to women who reported their first menses at least six months earlier and had a complaint of acne within the last 30 days. Women <18 years of age and postmenopausal women were excluded from the study population. Results: Participants included women 18- to 29-years old (67%) and women 30- to 49-years old (33%). The ethnicity of respondents was Caucasian (50%), African American (20%), Latino (19%), Asian (5%), and Other (6%). The majority of participants with perimenstrual acne reported the onset of acne between the ages of 12 and 18 years. Sixty-five percent of participants reported that their acne symptoms were worse with their menses. Of those who reported perimenstrual acne symptoms, 56 percent reported worsening symptoms in the week preceding their menses, 17 percent reported worsening symptoms during their menses, three percent reported worsening symptoms after their menses, and 24 percent reported worsening symptoms throughout their cycle. Thirty-five percent of patients with perimenstrual acne reported oral contraceptive pill use. Conclusion: A significant number of adult women have perimenstrual acne symptoms. This study has proven to be useful in characterizing perimenstrual acne flare and is one of the first qualitative documentations of the presence and degree of this disorder. PMID:25161758

  17. Use of tazarotene foam for the treatment of acne vulgaris

    PubMed Central

    Gregoriou, Stamatis; Kritsotaki, Eleftheria; Katoulis, Alexandros; Rigopoulos, Dimitris

    2014-01-01

    Acne vulgaris is a common inflammatory chronic disease of the pilosebaceous unit. It often requires long-term treatment, resulting in increased demand for topical medications that are popular with patients in order to achieve long-term compliance. Tazarotene foam 0.1% is a novel formulation of tazarotene. We review efficacy and tolerability studies of the new formulation, and suggest a possible place for the product in the management of acne vulgaris. PMID:24920932

  18. Over-the-counter treatments for acne and rosacea.

    PubMed

    Rosamilia, Lorraine Larsen

    2016-06-01

    Acne and rosacea are common inflammatory processes historically classified in the same disease category, but evolving understanding of their disparate pathophysiology and exacerbating factors have generated an enormous armamentarium of therapeutic possibilities. Patients seek over-the-counter therapies first when managing cutaneous disease; therefore, this review defines ingredients considered to be effective over-the-counter acne and rosacea products, their mechanisms, and safe formulations, including botanical components, oral supplements, and other anecdotal options in this vast skin care domain. PMID:27416314

  19. Effects of bee venom against Propionibacterium acnes-induced inflammation in human keratinocytes and monocytes.

    PubMed

    Kim, Jung-Yeon; Lee, Woo-Ram; Kim, Kyung-Hyun; An, Hyun-Jin; Chang, Young-Chae; Han, Sang-Mi; Park, Yoon-Yub; Pak, Sok Cheon; Park, Kwan-Kyu

    2015-06-01

    Propionibacterium acnes (P. acnes) cause inflammatory acne and play an important role in the pathogenesis of acne by inducing inflammatory mediators. P. acnes contributes to the inflammatory responses of acne by activating inflammatory cells, keratinocytes and sebocytes to secrete pro-inflammatory cytokines such as tumor necrosis factor-α (TNF-α), interleukin (IL)-1β and IL-8. Bee venom has traditionally been used in the treatment of certain immune-related diseases. However, there has not yet been a robust trial to prove the therapeutic effect of bee venom in skin inflammation. The aim of the present study was to investigate anti-inflammatory properties of bee venom in skin inflammation induced by P. acnes using keratinocytes (HaCaT) and monocytes (THP-1). P. acnes is known to stimulate the production of pro-inflammatory cytokines such as IL-1, IL-8, IL-12 and TNF-α. In the present study, the production of interferon-γ (IFN-γ), IL-1β, IL-8 and TNF-α was increased by P. acnes treatment in HaCaT and THP-1 cells. By contrast, bee venom effectively inhibited the secretion of IFN-γ, IL-1β, IL-8 and TNF-α. Furthermore, P. acnes treatment activated the expression of IL-8 and toll-like receptor 2 (TLR2) in HaCaT cells. However, bee venom inhibited the expression of IL-8 and TLR2 in heat-killed P. acnes. Based on these results, it is concluded that bee venom has an effective anti-inflammatory activity against P. acnes in HaCaT and THP-1 cells. Therefore, we suggest that bee venom is an alternative treatment to antibiotic therapy of acne. PMID:25872535

  20. 21 CFR 341.72 - Labeling of antihistamine drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of antihistamine drug products. 341.72 Section 341.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  1. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of astringent drug products. 347.52 Section 347.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling §...

  2. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of astringent drug products. 347.52 Section 347.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling §...

  3. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of astringent drug products. 347.52 Section 347.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling §...

  4. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of astringent drug products. 347.52 Section 347.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling §...

  5. 21 CFR 341.72 - Labeling of antihistamine drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of antihistamine drug products. 341.72 Section 341.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  6. 21 CFR 341.72 - Labeling of antihistamine drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of antihistamine drug products. 341.72 Section 341.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  7. 21 CFR 341.72 - Labeling of antihistamine drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of antihistamine drug products. 341.72 Section 341.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  8. 21 CFR 341.72 - Labeling of antihistamine drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of antihistamine drug products. 341.72 Section 341.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  9. Acne mechanica in athletes.

    PubMed

    Basler, R S

    1992-08-01

    Acne mechanica is a papulopustular eruption caused by the physical factors of pressure, occlusion, friction, and heat acting upon the skin, either separately or in unison. Athletes in certain sports are at particular risk for this condition. Dermatologists, if familiar with its presentation, can play a critical role in relieving its distracting symptoms during a competitive season, and eliminating it completely at the season's end. PMID:1387355

  10. Hirsutism and acne in polycystic ovary syndrome.

    PubMed

    Archer, Johanna S; Chang, R Jeffrey

    2004-10-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality affecting reproductive age women. Population-based studies estimate a prevalence of 5-10% [Obstet Gynecol 101 (2003) 995; Aust N Z J Obstet Gynaecol 41 (2001) 202]. The clinical characteristics of PCOS include hyperandrogenism, chronic anovulation, insulin resistance and infertility. Hyperandrogenism is generally manifested as hirsutism and acne. Both these clinical symptoms are treated with similar drug therapies, including oral contraceptive pills (OCPs), topical medications or antiandrogens such as spironolactone, flutamide and finasteride, as well as topical medications. Recent studies have shown that lower doses of these medications are as efficacious as high doses and have the advantage of decreased cost and an improved side-effect profile. Although hirsutism and acne can be considered cosmetic in nature, they cause significant social embarrassment and emotional distress. Physicians should be sensitive to these issues and approach patients in a caring and sympathetic manner. PMID:15380144

  11. The role of topical dermocosmetics in acne vulgaris.

    PubMed

    Araviiskaia, E; Dréno, B

    2016-06-01

    Acne is a common chronic inflammatory disease and treatment modalities based on acne severity are well established. The role of dermocosmetics in dermatology, and in particular acne, is becoming more important as more research elucidates the mechanisms of action of products in the pathogenesis of acne. Dermocosmetics have the potential to be used as monotherapy or in combination with medical treatment. Therefore, it has become important for dermatologists to understand dermocosmetics to effectively and appropriately advise patients on their use. The objective of this review was to provide new insights into the role of traditional and novel ingredients in dermocosmetics for the treatment of acne, based on the authors' objective assessment of the published literature. The type of products discussed include: those which have a sebostatic effect, such as topical antioxidants and niacinamide; agents targeting abnormal keratinization, such as salicylic acid, lipo-hydroxy acid, alpha-hydroxy acids, retinol-based products and linoleic acid; agents targeting Propionibacterium acnes, such as lauric acid; and anti-inflammatory agents such as nicotinamide, alpha-linolenic acid and zinc salts. Despite the scientific advances in understanding these cosmetic ingredients, there still remains a lack of rigorous controlled studies in this area. PMID:26916232

  12. Tretinoin-loaded liposomal formulations: from lab to comparative clinical study in acne patients.

    PubMed

    Rahman, Salwa Abdel; Abdelmalak, Nevine Shawky; Badawi, Alia; Elbayoumy, Tahany; Sabry, Nermeen; El Ramly, Amany

    2016-05-01

    Topical tretinoin is the most commonly used retinoid for acne. However, its irritative potential on the applied area and the barrier properties of the stratum corneum limit its use. The objective of the present study was to formulate tretinoin liposomal gel to obtain a formula with lower skin irritation potential and greater clinical effect. A statistical 2(4) factorial design was adopted. Sixteen formulae prepared and were properly evaluated. A candidate formula (F13G) prepared with 0.025% tretinoin, phospholipid- cholesterol-dicetylphosphate (9:1:0.01) and incorporated in 1% carbopol gel was selected for skin irritation test. Clinical study was conducted on acne patients and compared to marketed product. All liposomes formulations were spherical in shape. The addition of cholesterol in the film hydration method significantly decreased the vesicle size, and increased the percentage of incorporation efficiency at (p < 0.05). The presence of dicetylphosphate significantly increased drug release but did not affect the percentage of incorporation efficiency and vesicle size. The results of the clinical study in acne patients revealed that F13G showed significantly higher efficacy when compared to marketed product (p < 0.05). PMID:26004128

  13. The importance of photoprotection and moisturization in treating acne vulgaris.

    PubMed

    Bowe, Whitney P; Kircik, Leon H

    2014-08-01

    Skin care products are recognized by dermatologists as critical adjunctive therapeutic modalities for patients suffering from acne vulgaris (AV). Prescribing an acne medication without reviewing a patient's skin care regimen can lead to poor compliance, intolerable side effects, and resulting patient and physician frustration. Striking that delicate balance between maintaining the skin barrier while controlling oil and shine has always been a challenge when treating this chronic inflammatory condition, and it necessitates a unique set of ingredients and formulation. Cetaphil® DermaControl™ Moisturizer SPF 30 (Galderma Laboratories, L.P., Fort Worth, Texas) is a new generation of skin care specifically designed for acne-prone skin and acne-affected skin. Both Cetaphil® DermaControl™ Foam Wash and Cetaphil DermaControl Moisturizer SPF 30 incorporate pharmacologically tested, state-of-the-art ingredients and technologies that studies have shown impart substantial benefits to AV patients. PMID:25116982

  14. The utility of benzoyl peroxide in hydrophase base (Brevoxyl) in the treatment of acne vulgaris.

    PubMed

    Weinberg, Jeffrey M

    2006-04-01

    Available for more than 5 decades, benzoyl peroxide has been a "workhorse" of acne therapy. The benefits of this agent include reduction in Propionibacterium acnes (P. acnes) with decrease in inflammatory lesions, efficacy as both "leave on" and cleanser formulations and reduced emergence of antibiotic-resistant P. acnes strains. As the effect of benzoyl peroxide on P. acnes is a direct toxic effect rather than as a "true" antibiotic, resistance to benzoyl peroxide does not occur and has never been reported. Benzoyl peroxide in hydrophase base (Brevoxyl Creamy Washes and Gels) has shown significant efficacy in the treatment of acne, with lower irritancy than other benzoyl peroxide preparations. It is felt that the low irritancy of this product is related to a unique delivery vehicle containing dimethyl isosorbide, which dissolves benzoyl peroxide crystals on the skin. Clinical studies demonstrating the efficacy and safety of benzoyl peroxide in hydrophase base will be reviewed. PMID:16673802

  15. Acne pathogenesis: history of concepts.

    PubMed

    Tilles, Gérard

    2014-01-01

    From the first reliable descriptions of acne in the early 19th century, dermatologists recognized it as a disease of the pilosebaceous follicle. Until the middle of the 20th century, they hypothesized that seborrhoea, follicular keratosis and microorganisms could be individually responsible for the acne lesions. Inflammation was only regarded as the final and inescapable step of the acne process. Although the importance of these factors has been reevaluated, recent works still regarded them as mandatory. In the 1970s, the onset of isotretinoin dramatically improved acne management. It also provided great opportunities for a better understanding of the pathogenic factors of acne. This study analyzes their genesis and development from the seminal contributions until recent advances. PMID:25228295

  16. Large-scale survey to describe acne management in Brazilian clinical practice

    PubMed Central

    Seité, Sophie; Caixeta, Clarice; Towersey, Loan

    2015-01-01

    Background Acne is a chronic disease of the pilosebaceous unit that mainly affects adolescents. It is the most common dermatological problem, affecting approximately 80% of teenagers between 12 and 18 years of age. Diagnosis is clinical and is based on the patient’s age at the time the lesions first appear, and on its polymorphism, type of lesions, and their anatomical location. The right treatment for the right patient is key to treating acne safely. The aim of this investigational survey was to evaluate how Brazilian dermatologists in private practice currently manage acne. Materials and methods Dermatologists practicing in 12 states of Brazil were asked how they manage patients with grades I, II, III, and IV acne. Each dermatologist completed a written questionnaire about patient characteristics, acne severity, and the therapy they usually prescribe for each situation. Results In total, 596 dermatologists were interviewed. Adolescents presented as the most common acneic population received by dermatologists, and the most common acne grade was grade II. The doctors could choose more than one type of treatment for each patient, and treatment choices varied according to acne severity. A great majority of dermatologists considered treatment with drugs as the first alternative for all acne grades, choosing either topical or oral presentation depending on the pathology severity. Dermocosmetics were chosen mostly as adjunctive therapy, and their inclusion in the treatment regimen decreased as acne grades increased. Conclusion This survey illustrates that Brazilian dermatologists employ complex treatment regimens to manage acne, choosing systemic drugs, particularly isotretinoin, even in some cases of grade I acne, and heavily prescribe antibiotics. Because complex regimens are harder for patients to comply with, this result notably raises the question of adherence, which is a key factor in successful treatment. PMID:26609243

  17. Midchildhood acne associated with inhaled corticosteroids: report of two cases and review of the literature.

    PubMed

    Liu, Kristina J; Antaya, Richard J

    2014-01-01

    Midchildhood acne has been attributed to a number of causes in the literature, including adrenocortical tumor, hyperandrogenemia due to hypothalamic dysfunction, and contact with greasy topical skin care products. There are only a few case reports of inhaled steroids causing acneiform eruptions, all of which occurred in adults and with symptoms suggesting that the acne resulted from systemic absorption. We present two cases of comedonal and inflammatory midchildhood acne temporally associated with the use of inhaled corticosteroids administered through face masks, implicating a causative relationship between topical steroid exposure and midchildhood acne that does not necessitate systemic absorption. PMID:23437845

  18. Evaluation and Management of Refractory Acne Vulgaris in Adolescent and Adult Men.

    PubMed

    McCarty, Morgan

    2016-04-01

    Acne vulgaris alters the normal skin physiology, impairing stratum corneum and transepidermal water loss. A male's normal skin physiologic state is different than a female's and may have implications when choosing treatment when the skin is altered in a disease state. Transepidermal water loss, pH, and sebum production are different between the sexes. Several underlying conditions present in male acne patients at several ages that may require a more in-depth evaluation. As knowledge of the pathogenesis of acne expands, the differences in skin physiology between the sexes may alter the manner in which male patients with acne medications are approached. PMID:27015780

  19. Defining Patient Centric Pharmaceutical Drug Product Design.

    PubMed

    Stegemann, Sven; Ternik, Robert L; Onder, Graziano; Khan, Mansoor A; van Riet-Nales, Diana A

    2016-09-01

    The term "patient centered," "patient centric," or "patient centricity" is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.e., assuring adequate patient adherence and the anticipate drug safety and effectiveness. Relevant pharmaceutical design aspects may e.g., involve the selection of the route of administration, the tablet size and shape, the ease of opening the package, the ability to read the user instruction, or the ability to follow the recommended (in-use) storage conditions. Currently, a harmonized definition on patient centric drug development/design has not yet been established. To stimulate scientific research and discussions and the consistent interpretation of test results, it is essential that such a definition is established. We have developed a first draft definition through various rounds of discussions within an interdisciplinary AAPS focus group of experts. This publication summarizes the outcomes and is intended to stimulate further discussions with all stakeholders towards a common definition of patient centric pharmaceutical drug product design that is useable across all disciplines involved. PMID:27317470

  20. Evaluation of Acne Quality of Life and Clinical Severity in Acne Female Adults

    PubMed Central

    Kokandi, Amal

    2010-01-01

    Acne is a common disease especially among teenagers. It has a considerable psychological impact on affected individuals. The aim of this paper was to assess if the effect of acne on acne-related quality of life is correlated to acne clinical severity. 112 university female students attending the university medical clinics with acne complaints were examined. Cardiff Acne Disability Index (CADI) was used to assess acne-related quality of life, and global acne grading system (GAGS) was used to assess clinical severity of acne. There was no correlation between acne severity (GAGS scoring system) and quality of life impairment as assessed by CADI score (r = 0.145, P = .127). Additionally, CADI score did not correlate with disease duration or age of patients. We therefore conclude that acne clinical severity alone does not affect acne-related quality of life changes. Many other factors might play a role. PMID:20706683

  1. Combined oral contraceptives for the treatment of acne: a practical guide.

    PubMed

    Arrington, Elizabeth A; Patel, Nishit S; Gerancher, Karen; Feldman, Steven R

    2012-08-01

    Many therapies exist in the arsenal of drugs available to dermatologists for the treatment of acne vulgaris. Among them, hormonal therapy stands out as a unique and highly efficacious treatment modality. Although some dermatologists may be hesitant to prescribe hormonal therapies, they can be safely and appropriately used in eligible female patients to treat acne vulgaris. Herein, current issues regarding the hormonal treatment of acne in the form of combined oral contraceptives (COCs) are presented, and a practical method for implementing this therapy is proposed. Specifically, drug selection, associated risks, benefits, monitoring, and counseling are discussed, with emphasis on the practicality of use in the clinical setting. PMID:22988652

  2. [Antibiotics, azelaic acid and benzoyl peroxide in topical acne therapy].

    PubMed

    Fluhr, Joachim W; Degitz, Klaus

    2010-03-01

    Benzoyl peroxide was introduced as a basic treatment already in acne therapy 1934. The mechanism of action is the reduction of anaerobe bacteria by strong oxidation processes. No resistancies have been ever reported. BPO is available in 2.5, 5 and 10 % formulations. Its efficacy is slightly related to the strength of concentrations, but the side effect profile with burning, erythema and desquamation is increasing with concentrations. BPO 5% mostly is efficient enough to control acne of grades I to II according to the Kligman & Plewig classification. BPO my bleach clothes and hair. It is the most costeffective topical drug in acne of grades I-II. Inflammatory acne of the papular-pustular type I-II can also be treated by topical antibiotics such as erythromycin, clindamycin, and, less frequent and today not anymore recommended tetracyclines. Mechanism of action is not alone an antibacterial but anti inflammatory effect. The efficacy and penetration of the topical antibiotics between the groups are similar. Randomized studies have shown that concentrations of 2-4% are equivalent to oral tetracycline and minocycline in mild to moderate acne. Combinatory formulations with BPO and with retinoids enhance the efficacy significantly. Topical antibiotics plus BPO show less bacterial resistancies as topical antibiotics alone. Antibiotics should therefore not be used as monotherapy. Moreover gram negative folliculitis may develop. Azelaic acid is acting as an antimicrobial and can also reduce comedones. It can also be used in pregnancy and during the lactation period. PMID:20482689

  3. 21 CFR 211.208 - Drug product salvaging.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  4. 21 CFR 211.204 - Returned drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  5. 21 CFR 211.204 - Returned drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  6. 21 CFR 211.208 - Drug product salvaging.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  7. 21 CFR 211.208 - Drug product salvaging.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  8. 21 CFR 211.204 - Returned drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  9. 21 CFR 211.204 - Returned drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  10. 21 CFR 211.208 - Drug product salvaging.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  11. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control...

  12. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control...

  13. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control...

  14. 21 CFR 211.204 - Returned drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  15. 21 CFR 211.208 - Drug product salvaging.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged...

  16. 21 CFR 211.134 - Drug product inspection.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling...

  17. 21 CFR 211.94 - Drug product containers and closures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control...

  18. 21 CFR 332.30 - Labeling of antiflatulent drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... commerce of unapproved new drugs in violation of section 505(a) of the act. (1) (Select one of the... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of antiflatulent drug products. 332.30 Section 332.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  19. Management of acne vulgaris with hormonal therapies in adult female patients.

    PubMed

    Husein-ElAhmed, Husein

    2015-01-01

    Acne vulgaris is a very common condition affecting up of 93% of adolescents. Although rare, this disease may persist in adulthood. In adult women with acne (those older than 25 years old), this condition is particularly relevant because of the refractory to conventional therapies, which makes acne a challenge for dermatologists in this group of patients. In order to its potential risk for chronicity and the involvement of visible anatomical sites such as face and upper torso, acne has been associated with a wide spectrum of psychological and social dysfunction such as depression, anxiety, suicidal ideation, somatization, and social inhibition. In particular, adult women with acne have been shown to be adversely impacted by the effect of acne on their quality of life. For the last four decades, dermatologists have used hormonal therapies for the management of acne vulgaris in adult women, which are considered a rational choice given the severity and chronicity of this condition in this group of patients. The aim of this work is to review the hormonal drugs for management of acne. PMID:25845307

  20. Antimicrobial activities of ozenoxacin against isolates of propionibacteria and staphylococci from Japanese patients with acne vulgaris.

    PubMed

    Nakajima, Akiko; Ikeda, Fumiaki; Kanayama, Shoji; Okamoto, Kazuaki; Matsumoto, Tatsumi; Ishii, Ritsuko; Fujikawa, Akira; Takei, Katsuaki; Kawashima, Makoto

    2016-08-01

    Ozenoxacin, a novel non-fluorinated topical quinolone, was assessed for in vitro antimicrobial activity against clinical isolates of propionibacteria and staphylococci according to the broth microdilution method recommended by the Clinical and Laboratory Standards Institute. The isolates used in this study were collected from Japanese patients with acne vulgaris during a period from 2012 to 2013. The MIC90s of ozenoxacin against Propionibacterium acnes (n=266), Propionibacterium granulosum (n=10), Staphylococcus aureus (n=23), Staphylococcus epidermidis (n=229) and other coagulase-negative staphylococci (n=82) were ≤0.06, ≤0.06, ≤0.06, 0.125 and ≤0.06 µg ml-1, respectively. The antimicrobial activity of ozenoxacin against the clinical isolates of propionibacteria and staphylococci was greater than that of five reference antimicrobial agents which have been used for the treatment of acne vulgaris. The MICs of ozenoxacin were correlated with those of nadifloxacin in P. acnes and S. epidermidis isolates. However, the MICs of ozenoxacin were 0.25-0.5 µg ml-1 and 0.5-8 µg ml-1 against nadifloxacin-resistant P. acnes (MIC: ≥8 µg ml-1; n=8) and S. epidermidis (MIC: ≥64 µg ml-1; n=10), respectively. These results indicated the potent antimicrobial activity against P. acnes and S. epidermidis isolates resistant to nadifloxacin. Topical ozenoxacin could represent an alternative therapeutic drug for acne vulgaris based on its potent antimicrobial activity against the isolates of propionibacteria and staphylococci from acne patients. PMID:27305898

  1. Why Do I Get Acne?

    MedlinePlus

    ... you've been exercising. Many over-the-counter lotions and creams containing salicylic acid or benzoyl peroxide ... Sometimes even though they wash properly and try lotions and oil-free makeup, people get acne anyway — ...

  2. Etanercept-induced cystic acne.

    PubMed

    Kashat, Maria; Caretti, Katherine; Kado, Jessica

    2014-07-01

    Tumor necrosis factor α antagonists are potent biologics used to treat a variety of autoimmune disorders such as rheumatoid arthritis, ankylosing spondylitis, Crohn disease, psoriasis, and psoriatic arthritis. These medications are known to have many side effects (eg, infusion reactions, cytopenia, risk for infection, heart failure); however, only a few cases of acne vulgaris have been associated with the use of these biologics, particularly infliximab and adalimumab. We report a rare case of etanercept-induced cystic acne. PMID:25101341

  3. Photodynamic therapy of acne vulgaris.

    NASA Astrophysics Data System (ADS)

    Ershova, Ekaterina Y.; Karimova, Lubov N.; Kharnas, Sergey S.; Kuzmin, Sergey G.; Loschenov, Victor B.

    2003-06-01

    Photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) was tested for the treatment of acne vulgaris. Patients with acne were treated with ALA plus red light. Ten percent water solution of ALA was applied with 1,5-2 h occlusion and then 18-45 J/cm2 630 nm light was given. Bacterial endogenous porphyrins fluorescence also was used for acne therapy. Treatment control and diagnostics was realized by fluorescence spectra and fluorescence image. Light sources and diagnostic systems were used: semiconductor laser (λ=630 nm, Pmax=1W), (LPhT-630-01-BIOSPEC); LED system for PDT and diagnostics with fluorescent imager (λ=635 nm, P=2W, p=50 mW/cm2), (UFPh-630-01-BIOSPEC); high sensitivity CCD video camera with narrow-band wavelength filter (central wavelength 630 nm); laser electronic spectrum analyzer for fluorescent diagnostics and photodynamic therapy monitoring (LESA-01-BIOSPEC). Protoporphyrin IX (PP IX) and endogenous porphyrins concentrations were measured by fluorescence at wavelength, correspondingly, 700 nm and 650 nm. It was shown that topical ALA is converted into PP IX in hair follicles, sebaceous glands and acne scars. The amount of resulting PP IX is sufficient for effective PDT. There was good clinical response and considerable clearance of acne lesion. ALA-PDT also had good cosmetic effect in treatment acne scars. PDT with ALA and red light assist in opening corked pores, destroying Propionibacterium acnes and decreasing sebum secretion. PDT treatment associated with several adverse effects: oedema and/or erytema for 3-5 days after PDT, epidermal exfoliation from 5th to 10th day and slight pigmentation during 1 month after PDT. ALA-PDT is effective for acne and can be used despite several side effects.

  4. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 320 (formerly Docket No. 00N-1484) RIN...: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA... products: Janet Norden, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

  5. Treatment of Acne in Pregnancy.

    PubMed

    Chien, Anna L; Qi, Ji; Rainer, Barbara; Sachs, Dana L; Helfrich, Yolanda R

    2016-01-01

    Acne vulgaris is a common disease of the pilosebaceous unit and affects adolescents and adults. Because high-quality guidelines regarding treatment of acne in pregnancy are scarce, management of this condition can be challenging. We describe the safety profile of common therapies and outline approaches based on available evidence. Topical azelaic acid or benzoyl peroxide can be recommended as baseline therapy. A combination of topical erythromycin or clindamycin with benzoyl peroxide is recommended for inflammatory acne. Oral erythromycin or cephalexin is generally considered safe for moderate to severe inflammatory acne when used for a few weeks. A short course of oral prednisolone may be useful for treating fulminant nodular cystic acne after the first trimester. In general, topical and oral antibiotics should not be used as monotherapy, but combined with topical benzoyl peroxide to decrease bacterial resistance. Oral retinoids are teratogenic and absolutely contraindicated for women who are pregnant or considering pregnancy. Although some complementary therapies including micronutrients and nonpharmacologic treatments seem to be well tolerated, limited data exist regarding their safety and efficacy, and they are not currently recommended during pregnancy. The risk-to-benefit ratio, efficacy, acceptability, and costs are considerations when choosing a treatment for acne in pregnancy. PMID:26957383

  6. [Dangerous drugs: products containing synthetic chemicals].

    PubMed

    Kamijo, Yoshito

    2016-02-01

    When the patients poisoned with "dangerous drugs", that is, products containing synthetic chemicals such as synthetic cannabinoids and cathinones, are transferred to the emergency facilities, the chemicals really consumed cannot be determined there. So, supportive care may be the most important strategy for treating them. For example, those with serious consciousness disturbance should be supported with ventilator after intubation. Those with remarkable excitatory CNS or sympathetic symptoms, benzodiazepines such as diazepam and midazolam, should be administered. Those with hallucination or delusion, antipsychotics such as haloperidol or risperidone should be administered. Those with rhabdomyolysis, hypermyoglobinemia and acute kidney injury, intravenous fluids and hemodialysis should be introduced. PMID:26915246

  7. Vitamin B12 modulates the transcriptome of the skin microbiota in acne pathogenesis.

    PubMed

    Kang, Dezhi; Shi, Baochen; Erfe, Marie C; Craft, Noah; Li, Huiying

    2015-06-24

    Various diseases have been linked to the human microbiota, but the underlying molecular mechanisms of the microbiota in disease pathogenesis are often poorly understood. Using acne as a disease model, we aimed to understand the molecular response of the skin microbiota to host metabolite signaling in disease pathogenesis. Metatranscriptomic analysis revealed that the transcriptional profiles of the skin microbiota separated acne patients from healthy individuals. The vitamin B12 biosynthesis pathway in the skin bacterium Propionibacterium acnes was significantly down-regulated in acne patients. We hypothesized that host vitamin B12 modulates the activities of the skin microbiota and contributes to acne pathogenesis. To test this hypothesis, we analyzed the skin microbiota in healthy subjects supplemented with vitamin B12. We found that the supplementation repressed the expression of vitamin B12 biosynthesis genes in P. acnes and altered the transcriptome of the skin microbiota. One of the 10 subjects studied developed acne 1 week after vitamin B12 supplementation. To further understand the molecular mechanism, we revealed that vitamin B12 supplementation in P. acnes cultures promoted the production of porphyrins, which have been shown to induce inflammation in acne. Our findings suggest a new bacterial pathogenesis pathway in acne and provide one molecular explanation for the long-standing clinical observation that vitamin B12 supplementation leads to acne development in a subset of individuals. Our study discovered that vitamin B12, an essential nutrient in humans, modulates the transcriptional activities of skin bacteria, and provided evidence that metabolite-mediated interactions between the host and the skin microbiota play essential roles in disease development. PMID:26109103

  8. Systemic isotretinoin therapy normalizes exaggerated TLR-2-mediated innate immune responses in acne patients

    PubMed Central

    Dispenza, Melanie C.; Wolpert, Ellen B.; Gilliland, Kathryn L.; Dai, Pingqi; Cong, Zhaoyuan; Nelson, Amanda M.; Thiboutot, Diane M.

    2012-01-01

    Retinoids are used in the treatment of inflammatory skin diseases and malignancies, but studies characterizing the in vivo actions of these drugs in humans are lacking. Isotretinoin is a pro-drug for all-trans retinoic acid that can induce long-term remissions of acne; however, its complete mechanism of action is unknown. We hypothesized that isotretinoin induces remission of acne by normalizing the innate immune response to the commensal bacterium P. acnes. Compared to normal subjects, peripheral blood monocytes from acne patients expressed significantly higher levels of TLR-2 and exhibited significantly greater induction of TLR-2 expression following P. acnes stimulation. Treatment of patients with isotretinoin significantly decreased monocyte TLR-2 expression and subsequent inflammatory cytokine response to P. acnes by one week of therapy. This effect was sustained six months following cessation of therapy, indicating that TLR-2 modulation may be involved in the durable therapeutic response to isotretinoin. This study demonstrates that isotretinoin exerts immunomodulatory effects in patients and sheds light on a potential mechanism for its long-term effects in acne. The modulation of TLR-2 expression on monocytes has important implications in other inflammatory disorders characterized by TLR-2 dysregulation. PMID:22513780

  9. Medicinal Plants for the Treatment of Acne Vulgaris: A Review of Recent Evidences

    PubMed Central

    Nasri, Hamid; Bahmani, Mahmoud; Shahinfard, Najmeh; Moradi Nafchi, Atefeh; Saberianpour, Shirin; Rafieian Kopaei, Mahmoud

    2015-01-01

    Context: Acne vulgaris affects about 85% of teenagers and may continue to adulthood. There are about two million visits to physicians per year for teenagers and the direct cost of acne treatment in the US exceeds $1 billion per year. Evidence Acquisition: A wide variety of treatment regimens exist for acne vulgaris including benzoil peroxide, retinoids, isotretinoids, keratolytic soaps, alpha hydroxy acids, azelaic acid, salicilic acid as well as hormonal, anti-androgen or antiseborrheic treatments. However, none of these methods is free of side effects and their exact role in therapy is not clear. In this paper apart from presenting the possible causes of acne vulgaris and its available drugs, recently published papers about medicinal plants used in the treatment of acne vulgaris were reviewed. Results: Consumption of alternative and complementary medicine, including medicinal plants, is increasing and is common amongst patients affected by acne and infectious skin diseases. Medicinal plants have a long history of use and have been shown to possess low side effects. These plants are a reliable source for preparation of new drugs. Conclusions: Many plants seem to have inhibitory effects on the growth of bacteria, fungi and viruses in vitro. However, there are a few clinical evidences about the effectiveness and safety of these plants in the treatment of acne and other skin infections. PMID:26862380

  10. Randomized, Double-Blind, Split-Face Study to Compare the Irritation Potential of Two Topical Acne Formulations Over a 21-Day Treatment Period.

    PubMed

    Kircik, Leon H; Bhatt, Varsha; Martin, Gina; Pillai, Radhakrishnan

    2016-02-01

    The use of fixed combinations in acne vulgaris (acne) is very common, however comparative clinical trial data are limited. Cutaneous tolerability can influence patient compliance, and concerns about skin irritation with topical acne treatments have lead to a number of comparative split-face studies.
    Recently, a new fixed combination product was introduced (clin 1.0%-BP 3.75% gel) that was shown to be effective in reducing both inflammatory and noninflammatory lesions in moderate to severe acne. Here, we assess the tolerability of clin 1.0%-BP 3.75% gel compared with adap 0.1%-BP 2.5% gel in healthy volunteers with no apparent facial redness or dryness over 21-days, using a split-face methodology.
    Especially over the first two weeks of treatment, clin 1.0%-BP 3.75% gel was more tolerable than adap 0.1%-BP 2.5% gel, with statistically significant differences in cumulative change from baseline starting as early as day 8 (dryness) and day 9 (erythema), and composite index on days 8-12 and 16. Transepidermal water loss was less with clin 1.0%-BP 3.75% gel, although the difference was not statistically significant.

    J Drugs Dermatol. 2016;15(2):178-182. PMID:26885785

  11. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... degradation products and updates the draft guidance ``ANDAs: Impurities in Drug Products'' announced in... final guidance to: (1) Update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products (thresholds and procedures) in abbreviated new...

  12. New and emerging treatments in dermatology: acne.

    PubMed

    Katsambas, A; Dessinioti, C

    2008-01-01

    Topical retinoids, benzoyl peroxide, azelaic acid, and topical and oral antibiotics remain the milestone of treatment for mild to moderate acne vulgaris. Oral isotretinoin is useful for the treatment of severe nodular acne, treatment-resistant acne, and acne with a risk of physical or psychological scarring. Hormonal treatment in female acne is useful in resistant or late-onset acne. With increasing concerns regarding teratogenicity of isotretinoin and increasing antibiotic resistance, there is a clear need for therapeutic alternatives to these long-used treatments. Research in the pathogenesis of acne has allowed for new therapies and future perspectives regarding acne to evolve. They include low-dose long-term isotretinoin regimens, insulin-sensitizing agents, 5alpha-reductase type 1 inhibitors, topical photodynamic therapy, new combination formulations, dietary interventions, and antiinflammatory agents such as lipoxygenase inhibitors. PMID:18394082

  13. Acne, cystic on the face (image)

    MedlinePlus

    The face is the most common location of acne. Here, there are 4 to 6 millimeter red ( ... scars and fistulous tract formation (connecting passages). Severe acne may have a profound psychological impact and may ...

  14. Acne, vulgaris on the back (image)

    MedlinePlus

    Acne frequently occurs on the back. Here, there are 2 to 6 millimeter wide erythematous (red) pustules ... Permanent scarring may follow a severe case of acne. Men are more often affected on their shoulders ...

  15. Acne - Multiple Languages: MedlinePlus

    MedlinePlus

    ... Supplements Videos & Tools You Are Here: Home → Multiple Languages → All Health Topics → Acne URL of this page: https://www.nlm.nih.gov/medlineplus/languages/acne.html Other topics A-Z A B ...

  16. Photopneumatic Technology in Acne Treatment and Skin Rejuvenation: Histological Assessment

    PubMed Central

    Omi, Tokuya

    2012-01-01

    Background and Aims: Recent reports indicate that a variety of light-based devices have been used for acne treatment and skin rejuvenation. A new technology combining intense pulsed light with negative pressure, photopneumatic technology, has recently attracted interest. The present study assessed acne treatment and skin rejuvenation with this novel approach Subjects and Methods: Acne, 450 nm tip. Five Japanese volunteers (1 male, 4 female; mean age 28.6 yr; skin type III) with mild to moderate/moderate active acne participated. The face was treated with 2 sessions, 2 weeks apart. Biopsies were obtained immediately after the first session and 1 week after the second session, and routinely processed for transmission electron microscopy (TEM). Rejuvenation, profusion tip with topical preparation. In 5 Japanese volunteers (3 male, 2 female; mean age 37.6 yr, skin type III), the volar aspect of both forearms was treated with the 530 nm head at P6 (around 12 J/cm2). The left arm was then treated with a pre-infused profusion tip and vacuum only. Four sessions were given, 14-day intervals. Biopsies were taken from both arms 2 weeks after the 2nd session and 3 weeks after the 4th session. One-half of each biopsy was assessed with histo-and immunohistochemistry, and the other with TEM. Results Acne trial: A combination of physical extraction of comedones, mild photothermal damage of the follicle and damage to identified bacilli was noted post-treatment, with macroscopic improvement of the skin. Rejuvenation with profusion: Significant morphological and immunohistochemical differences were seen between the control and profusion-treated arms at the first assessment. These differences became less significant at the 2nd assessment. Conclusions Macroscopically and histologically, photopneumatic technology improved acne lesions, suggesting a synergistic effect between the components of the technology. In skin rejuvenation, the profusion therapy accelerated the regenerative

  17. Fillers for the improvement in acne scars

    PubMed Central

    Wollina, Uwe; Goldman, Alberto

    2015-01-01

    Acne is a common inflammatory disease. Scarring is an unwanted end point of acne. Both atrophic and hypertrophic scar types occur. Soft-tissue augmentation aims to improve atrophic scars. In this review, we will focus on the use of dermal fillers for acne scar improvement. Therefore, various filler types are characterized, and available data on their use in acne scar improvement are analyzed. PMID:26491364

  18. 21 CFR 355.50 - Labeling of anticaries drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Section 355.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 355.50... between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for...

  19. 21 CFR 355.50 - Labeling of anticaries drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 355.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 355.50... between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for...

  20. 21 CFR 355.50 - Labeling of anticaries drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 355.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 355.50... between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for...

  1. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 357.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE... be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during,...

  2. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 357.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE... be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during,...

  3. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 357.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE... be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during,...

  4. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Section 357.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE... be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during,...

  5. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Section 357.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE... be taken alone or with milk or fruit juice. Use of a laxative is not necessary prior to, during,...

  6. Newer approaches to the treatment of acne vulgaris.

    PubMed

    Simonart, Thierry

    2012-12-01

    The multifactorial etiology of acne vulgaris makes it challenging to treat. Current treatments include topical retinoids, benzoyl peroxide, topical and systemic antibiotics, azelaic acid, and systemic isotretinoin. Adjunctive and/or emerging approaches include topical dapsone, taurine bromamine, resveratrol, chemical peels, optical treatments, as well as complementary and alternative medications. The purpose of this paper is to discuss the therapies available for acne and their latest developments, including new treatment strategies (i.e. re-evaluation of the use of oral antibiotics and avoidance of topical antibiotic monotherapy, use of subantimicrobial antibiotic dosing, use of low-dose isotretinoin, optical treatments), new formulations (microsponges, liposomes, nanoemulsions, aerosol foams), new combinations (fixed-combination products of topical retinoids and topical antibiotics [essentially clindamycin] or benzoyl peroxide), new agents (topical dapsone, taurine bromamine, resveratrol) and their rationale and likely place in treatment. Acne vaccines, topical natural antimicrobial peptides, and lauric acid represent other promising therapies. PMID:22920095

  7. Sunflower Seed and Acne Vulgaris

    PubMed Central

    Mohebbipour, Alireza; Sadeghi-Bazargani, Homayoun; Mansouri, Mona

    2015-01-01

    Background: Regardless of the overall association between diet and acne which cannot be easily ignored, there might be an association between specific nutrients and acne development or improvement. Objectives: The aim of this study was to assess the effect of dietary intake of sunflower seeds on acne severity and the pattern of acne lesions. Patients and Methods: In a randomized controlled trial, 50 patients aged 15 - 30 years old with acne vulgaris were enrolled through consecutive convenient sampling, in a dermatology clinic in Ardabil, Iran. They were randomly allocated into two trial arms. Those in the control group were asked to stop eating sunflower seeds if they did before. In the intervention group, they consumed 25 g sunflower-containing food daily for seven days. The primary outcome of interest was 10% increase/decrease in the baseline acne severity index (ASI), sustained to the end of the follow-up period on day 14. Results: The mean ASI did not change significantly through the study period in the control group, but it increased in the sunflower group from 62 at the baseline to 86.8 after two weeks (P < 0.001). The ASI mean change was 24.8 in the sunflower group compared to 4.9 in the control group (P < 0.001). The global acne grading score (GAGS) did not significantly change in any of the groups and the difference in the change of GAGS was not significant between the groups (2.4 in the sunflower group versus 1.6 in the control group). Twenty two subjects (88%) in the sunflower group versus 9 (36%) in the control group had at least 10% increment in ASI throughout the follow-up period (P < 0.001). The relative risk of developing the primary outcome in taking the sunflower seed intervention was 2.4 (95% CI: 1.4 - 4.2). The observed risk difference was 0.52 (95% CI: 0.29 - 0.75). Conclusions: Sunflower seed intake appears to aggravate acne vulgaris; however, further evidence is needed to ban sunflower seed intake in patients with acne. Considering the

  8. Acne mechanica due to an orthopedic crutch.

    PubMed

    Kang, Y C; Choi, E H; Hwang, S M; Lee, W S; Lee, S H; Ahn, S K

    1999-08-01

    Acne mechanica describes local irritation due to the skin being pressured, occluded, rubbed, squeezed, stretched, or heated. Examples of various physical traumas that provoke lesions in acne patients are given. Users of orthopedic crutches are at particular risk for such conditions. A crutch is another extrinsic factor to be added to the list of causes of acne mechanica. PMID:10467500

  9. Therapeutic Approach to Acne and Rosacea, Introduction.

    PubMed

    Graber, Emmy M

    2016-06-01

    Acne has been written about since ancient Greek times and was a recognized entity even during Cleopatra's reign. Today, acne is pervasive in most cultures and is the number two reason why patients visit a dermatologist in the United States. It is the eighth most common disease worldwide. Despite the longstanding awareness of acne and its prevalence, no perfect treatment yet exists. PMID:27416307

  10. [Acne therapy with topical benzoyl peroxide, antibiotics and azelaic acid].

    PubMed

    Worret, Wolf-Ingo; Fluhr, Joachim W

    2006-04-01

    Benzoyl peroxide (BPO) was introduced in the treatment of acne in 1934. Despite the fact that only few randomized trials have been published, BPO is considered the standard in topical acne treatment. Anaerobic bacteria are reduced by oxidative mechanisms and the induction of resistant strains is reduced. Topical formulations are available at concentrations of 2.5, 5, 10 and 20 %. The effect is dose-dependent, but the irritation increases with higher concentrations. Usually 5 % BPO is sufficient to control acne grade I-II. Due to its strong oxidative potential, patients should be advised that BPO may bleach colored and dark clothing, bedding and even hair. BPO is safe for use in pregnant and lactating females because it is degraded to benzoic acid. It is a cost-effective treatment for acne grade I-II. Patients with papulopustular acne grade I-II, particularly with marked inflammation, show satisfactory improvement with topical antibiotic treatment. The following compounds are available and effective: erythromycin, clindamycin and tetracycline (the latter being less frequently used). A review in 1990 suggested that topical tetracycline was ineffective in the treatment of acne. Along with eliminating Propionibacterium acnes, the main mechanism of topical antibiotics is their antiinflammatory effect. All three penetrate the epidermal barrier well and are similarly efficacious. Randomized trials have shown that in concentrations of 2-4 %, their effects are comparable to oral tetracycline and minocycline. Combination therapy with retinoids or benzoyl peroxide (BPO) increases efficacy. Retinoids increase penetration and reduce comedones, while topical antibiotics primarily address inflammation. One side effect of topical antibacterial treatment is an increase in drug-resistant resident skin flora with gram-negative microorganisms prevailing, which can lead to gram-negative folliculitis. All three antibiotics fluoresce under black light which may produce interesting

  11. Acne tetrad in a family.

    PubMed

    Zisova, L; Sakakushev, B

    1994-01-01

    The authors report, for the first time in Bulgarian literature, a case of acne tetrad syndrome in a family. The patients were sisters who were found to have three of the four components of the syndrome: hidradenitis suppurativa, acne conglobata, and cysta pillaris. There was no evidence or anamnestic data for perifolliculitis capitis abscedens et suffodiens. In one of the sisters the syndrome showed a more precipitate clinical picture and was combined with other skin disorders (lichen ruber planus, neurodermitis circumscripta, hirsutismus). The patients had a familial predisposition to acne and pilar cycts. The complete blood analysis, all biochemical parameters, the cytogenetic analysis and hormonal status (testosterone and estrogens) showed no deviation from normal values. The patients did not report any disturbances during their menstrual cycles. The cellular immunity in one of the sisters was depressed. The patients and their children will be closely monitored. PMID:8698287

  12. 78 FR 72838 - Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act... to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products in... facility does not compound using a bulk drug substance unless: (1) The bulk drug substance appears on...

  13. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  14. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  15. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  16. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  17. Marinopyrroles: Unique Drug Discoveries Based on Marine Natural Products.

    PubMed

    Li, Rongshi

    2016-01-01

    Natural products provide a successful supply of new chemical entities (NCEs) for drug discovery to treat human diseases. Approximately half of the NCEs are based on natural products and their derivatives. Notably, marine natural products, a largely untapped resource, have contributed to drug discovery and development with eight drugs or cosmeceuticals approved by the U.S. Food and Drug Administration and European Medicines Agency, and ten candidates undergoing clinical trials. Collaborative efforts from drug developers, biologists, organic, medicinal, and natural product chemists have elevated drug discoveries to new levels. These efforts are expected to continue to improve the efficiency of natural product-based drugs. Marinopyrroles are examined here as a case study for potential anticancer and antibiotic agents. PMID:26332654

  18. Antimicrobial and anti-inflammatory properties of nostocionone isolated from Nostoc commune Vauch and its derivatives against Propionibacterium acnes.

    PubMed

    Itoh, Tomohiro; Tsuchida, Akihiro; Muramatsu, Yuji; Ninomiya, Masayuki; Ando, Masashi; Tsukamasa, Yasuyuki; Koketsu, Mamoru

    2014-06-01

    Propionibacterium acnes is the primary pathogenic agent responsible for acne vulgaris on the skin and hair follicles. Overgrowth of this bacterium inhibits growth and promotes follicular inflammation, with an associated increase in pro-inflammatory cytokine production. P. acnes has therefore been considered the main target for the prevention and medical treatment of acne vulgaris. The aim of this study was to evaluate the in vitro anti-P. acnes and anti-inflammatory properties of 6 compounds isolated from Nostoc commune. One of these compounds, nostocionone (Nost), and one of its derivatives, NostD3 [(1E,4E)-1-(3,4-dihydroxyphenyl)-5-(2,6,6-trimethylcyclohex-1-enyl)penta-1,4-dien-3-one], significantly inhibited P. acnes growth. Furthermore, we investigated the effects of Nost and NostD3 on heat-killed (hk) P. acnes-induced inflammation in macrophages. Both Nost and NostD3 suppressed hk P. acnes-induced nitric oxide (NO) production through the suppression of inducible NO synthase expression, following inactivation of nuclear factor kappa B. Taken together, our findings suggested that both Nost and NostD3 were promising agents for the treatment of acne vulgaris, and that NostD3 showed higher efficacy than Nost. PMID:24699048

  19. Drug Discovery Prospect from Untapped Species: Indications from Approved Natural Product Drugs

    PubMed Central

    Qin, Chu; Tao, Lin; Liu, Xin; Shi, Zhe; Zhang, Cun Long; Tan, Chun Yan; Chen, Yu Zong; Jiang, Yu Yang

    2012-01-01

    Due to extensive bioprospecting efforts of the past and technology factors, there have been questions about drug discovery prospect from untapped species. We analyzed recent trends of approved drugs derived from previously untapped species, which show no sign of untapped drug-productive species being near extinction and suggest high probability of deriving new drugs from new species in existing drug-productive species families and clusters. Case histories of recently approved drugs reveal useful strategies for deriving new drugs from the scaffolds and pharmacophores of the natural product leads of these untapped species. New technologies such as cryptic gene-cluster exploration may generate novel natural products with highly anticipated potential impact on drug discovery. PMID:22808057

  20. Acne-associated syndromes: models for better understanding of acne pathogenesis.

    PubMed

    Chen, W; Obermayer-Pietsch, B; Hong, J-B; Melnik, B C; Yamasaki, O; Dessinioti, C; Ju, Q; Liakou, A I; Al-Khuzaei, S; Katsambas, A; Ring, J; Zouboulis, C C

    2011-06-01

    Acne, one of the most common skin disorders, is also a cardinal component of many systemic diseases or syndromes. Their association illustrates the nature of these diseases and is indicative of the pathogenesis of acne. Congenital adrenal hyperplasia (CAH) and seborrhoea-acne-hirsutism-androgenetic alopecia (SAHA) syndrome highlight the role of androgen steroids, while polycystic ovary (PCO) and hyperandrogenism-insulin resistance-acanthosis nigricans (HAIR-AN) syndromes indicate insulin resistance in acne. Apert syndrome with increased fibroblast growth factor receptor 2 (FGFR2) signalling results in follicular hyperkeratinization and sebaceous gland hypertrophy in acne. Synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) and pyogenic arthritis-pyoderma gangrenosum-acne (PAPA) syndromes highlight the attributes of inflammation to acne formation. Advances in the understanding of the manifestation and molecular mechanisms of these syndromes will help to clarify acne pathogenesis and develop novel therapeutic modalities. PMID:21198949

  1. Developing a drug-like natural product library.

    PubMed

    Quinn, Ronald J; Carroll, Anthony R; Pham, Ngoc B; Baron, Paul; Palframan, Meredith E; Suraweera, Lekha; Pierens, Gregory K; Muresan, Sorel

    2008-03-01

    Addressing drug-like/lead-like properties of biologically active small molecules early in a lead generation program is the current paradigm within the drug discovery community. Lipinski's "rule of five" has become the most commonly used tool to assess the relationship between structures and drug-like properties. Sixty percent of the 126 140 unique compounds in The Dictionary of Natural Products had no violations of Lipinski's "rule of five". We have isolated 814 natural products based on their expected drug-like/lead-like properties to generate a natural product library (NPL) in which 85% of the isolated compounds had no Lipinski violations. The library demonstrates the feasibility of obtaining natural products known for rich chemical diversity with the required physicochemical properties for drug discovery. The knowledge generated in creation of the library of structurally characterized pure natural products may provide opportunities to front-load lead-like property space in natural product drug discovery programs. PMID:18257534

  2. Acne as a chronic systemic disease.

    PubMed

    Zouboulis, Christos C

    2014-01-01

    Acne is the most common skin disorder. In the majority of cases, acne is a disease that changes its skin distribution and severity over time; moreover, it can be a physically (scar development) and psychologically damaging condition that lasts for years. According to its clinical characteristics, it can be defined as a chronic disease according to the World Health Organization criteria. Acne is also a cardinal component of many systemic diseases or syndromes, such as congenital adrenal hyperplasia, seborrhea-acne-hirsutism-androgenetic alopecia syndrome, polycystic ovarian syndrome, hyperandrogenism-insulin resistance-acanthosis nigricans syndrome, Apert syndrome, synovitis-acne-pustulosis-hyperostosis-osteitis syndrome, and pyogenic arthritis-pyoderma gangrenosum-acne syndrome. Recent studies on the Ache hunter gatherers of Paraguay detected the lack of acne in association with markedly lower rates of obesity, diabetes mellitus, hyperlipidemia, and cardiovascular diseases, a finding that indicates either a nutritional or a genetic background of this impressive concomitance. PMID:24767186

  3. South-East Asia study alliance guidelines on the management of acne vulgaris in South-East Asian patients.

    PubMed

    Goh, Chee Leok; Abad-Casintahan, Flordeliz; Aw, Derrick Chen Wee; Baba, Roshidah; Chan, Lee Chin; Hung, Nguyen Thanh; Kulthanan, Kanokvalai; Leong, Hoe Nam; Medina-Oblepias, Marie Socouer; Noppakun, Nopadon; Sitohang, Irma Bernadette; Sugito, Titi Lestari; Wong, Su-Ni

    2015-10-01

    The management of acne in South-East Asia is unique, as Asian skin and local variables require a clinical approach unlike that utilized in other parts of the world. There are different treatment guidelines per country in the region, and a group of leading dermatologists from these countries convened to review these guidelines, discuss current practices and recent advances, and formulate consensus guidelines to harmonize the management of acne vulgaris in the region. Emphasis has been placed on formulating recommendations to impede the development of antibiotic resistance in Propionibacterium acnes. The group adopted the Acne Consensus Conference system for grading acne severity. The group recommends that patients may be treated with topical medications including retinoids, benzoyl peroxide (BPO), salicylic acid, a combination of retinoid and BPO, or a combination of retinoids and BPO with or without antibiotics for mild acne; topical retinoid with topical BPO and a oral antibiotic for moderate acne; and oral isotretinoin if the patient fails first-line treatment (a 6- or 8-week trial of combined oral antibiotics and topical retinoids with BPO) for severe acne. Maintenance acne treatment using topical retinoids with or without BPO is recommended. To prevent the development of antibiotic resistance, topical antibiotics should not be used as monotherapy or used simultaneously with oral antibiotics. Skin care, comprised of cleansing, moisturizing and sun protection, is likewise recommended. Patient education and good communication is recommended to improve adherence, and advice should be given about the characteristics of the skin care products patients should use. PMID:26211507

  4. The P450 system and mTORC1 signalling in acne.

    PubMed

    Melnik, Bodo C

    2014-05-01

    In this issue, Hellmann-Regen et al. suggested that anti-acne effects of erythromycin and tetracyclines may be related to their inhibitory effect of cytochrome P450-mediated degradation of all-trans-retinoic acid (ATRA). We have recently proposed that all anti-acne agents function by attenuation of increased mTORC1 signalling. This commentary links the P450 system to mTORC1 regulation in acne. Drug-mediated induction of P450 activity or P450 mutants with increased catabolic activity may reduce cellular ATRA levels and FoxO1 expression, thus reducing FoxO-mediated mTORC1 inhibition. In contrast, agents blocking ATRA degradation such as erythromycin and tetracyclines may improve acne by increasing FoxO1 expression with consecutive inhibition of mTORC1 signalling. PMID:24588627

  5. The role of isotretinoin in acne therapy: why not as first-line therapy? facts and controversies.

    PubMed

    Rigopoulos, Dimitris; Larios, George; Katsambas, Andreas D

    2010-01-01

    Acne is one of the most prevalent diseases in dermatology: Millions of people worldwide experience this distressing condition. To determine the appropriate therapeutic strategy, there is a strong need for a standardized classification system of acne. The exact molecular mechanism of action of isotretinoin is not completely understood; however, oral isotretinoin targets simultaneously at all major mechanisms of acne pathogenesis. Various mass media reports about the risk of teratogenicity and depression from isotretinoin usage as well as the creation of intense prevention programs have created an obstacle to the use of the most active available drug against acne, presenting isotretinoin as a very dangerous regimen. According to recommendations of several international experts, which we share, oral isotretinoin may be prescribed not only to patients with severe disease but indications should be broadened to also include patients with less severe forms of acne, especially in cases with scarring, significant psychologic stress, or failure to respond to conventional therapy. PMID:20082946

  6. 78 FR 38053 - Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ...The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) Extended-Release Tablet products approved under new drug application (NDA) 21-610 were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to......

  7. 21 CFR 332.30 - Labeling of antiflatulent drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Labeling of antiflatulent drug products. (a) Statement of identity. The labeling of the product contains... accidental overdose, seek professional assistance or contact a poison control center immediately.”...

  8. NdYag Laser for Acne Keloidalis Nuchae

    ClinicalTrials.gov

    2013-03-27

    Acne Keloidalis Nuchae; NdYag Laser; AKN; Acne Keloidalis; AK; Dermatitis Papillaris Capillitii; Folliculitis Keloidalis Nuchae; Sycosis Nuchae; Acne Keloid; Keloidal Folliculitis; Lichen Keloidalis Nuchae; Folliculitis Nuchae Scleroticans; Sycosis Framboesiformis

  9. Concerns and Awareness of Acne Patients About Isotretinoin in Qassim Region of Saudi Arabia

    PubMed Central

    Al-Harbi, Mana

    2010-01-01

    Background: Oral Isotretinoin is the most effective choice in the treatment of severe acne, It is the most widely prescribed teratogenic drug in the USA and Canada. Due to large number of its adverse effects and the necessity of long term use, patients have difficulties in complying with the treatment and some may refuse taking the drug. Objectives: To assess knowledge, concerns and awareness of acne patients in Qassim region, Saudi Arabia, about Isotretinoin, including the factors that may affect compliance. Subjects and Method: This non-interventional cross-sectional survey was conducted through distribution of questionnaires over two months period from 8th May to 23rd July 2009 in acne patients from the Qassim region. The returned questionnaires were analyzed using SPSS version 17.0. The P <0.05 was accepted as cut-off point for statistical significance. Results: Three hundred fifty six acne patients were included in the study, 57.6% were female and 42.3% were male; 76.7% knew about Isotretinoin and its uses, the main source of information (for both genders) was the physician, followed by other acne patients. Sixty three percent of subjects knew about the adverse effects of the drug. Dryness and teratogenicity were the most well-known adverse effects and 85.9% didn't have any objection in using the drug. Adverse effects followed by duration of the treatment were the top concerned issues. Out of those who were using the drug, dryness of the lips and face were the most disturbing adverse effects. Conclusion: A majority of acne patients have the knowledge about Isotretinoin and its adverse effects. This study highlighted the importance of health education for better acceptance of this drug. Patients should be instructed about proper moisturization methods while using this drug. PMID:21475525

  10. Acne Scars: Pathogenesis, Classification and Treatment

    PubMed Central

    Fabbrocini, Gabriella; Annunziata, M. C.; D'Arco, V.; De Vita, V.; Lodi, G.; Mauriello, M. C.; Pastore, F.; Monfrecola, G.

    2010-01-01

    Acne has a prevalence of over 90% among adolescents and persists into adulthood in approximately 12%–14% of cases with psychological and social implications. Possible outcomes of the inflammatory acne lesions are acne scars which, although they can be treated in a number of ways, may have a negative psychological impact on social life and relationships. The main types of acne scars are atrophic and hypertrophic scars. The pathogenesis of acne scarring is still not fully understood, but several hypotheses have been proposed. There are numerous treatments: chemical peels, dermabrasion/microdermabrasion, laser treatment, punch techniques, dermal grafting, needling and combined therapies for atrophic scars: silicone gels, intralesional steroid therapy, cryotherapy, and surgery for hypertrophic and keloidal lesions. This paper summarizes acne scar pathogenesis, classification and treatment options. PMID:20981308

  11. Linking diet to acne metabolomics, inflammation, and comedogenesis: an update.

    PubMed

    Melnik, Bodo C

    2015-01-01

    Acne vulgaris, an epidemic inflammatory skin disease of adolescence, is closely related to Western diet. Three major food classes that promote acne are: 1) hyperglycemic carbohydrates, 2) milk and dairy products, 3) saturated fats including trans-fats and deficient ω-3 polyunsaturated fatty acids (PUFAs). Diet-induced insulin/insulin-like growth factor (IGF-1)-signaling is superimposed on elevated IGF-1 levels during puberty, thereby unmasking the impact of aberrant nutrigenomics on sebaceous gland homeostasis. Western diet provides abundant branched-chain amino acids (BCAAs), glutamine, and palmitic acid. Insulin and IGF-1 suppress the activity of the metabolic transcription factor forkhead box O1 (FoxO1). Insulin, IGF-1, BCAAs, glutamine, and palmitate activate the nutrient-sensitive kinase mechanistic target of rapamycin complex 1 (mTORC1), the key regulator of anabolism and lipogenesis. FoxO1 is a negative coregulator of androgen receptor, peroxisome proliferator-activated receptor-γ (PPARγ), liver X receptor-α, and sterol response element binding protein-1c (SREBP-1c), crucial transcription factors of sebaceous lipogenesis. mTORC1 stimulates the expression of PPARγ and SREBP-1c, promoting sebum production. SREBP-1c upregulates stearoyl-CoA- and Δ6-desaturase, enhancing the proportion of monounsaturated fatty acids in sebum triglycerides. Diet-mediated aberrations in sebum quantity (hyperseborrhea) and composition (dysseborrhea) promote Propionibacterium acnes overgrowth and biofilm formation with overexpression of the virulence factor triglyceride lipase increasing follicular levels of free palmitate and oleate. Free palmitate functions as a "danger signal," stimulating toll-like receptor-2-mediated inflammasome activation with interleukin-1β release, Th17 differentiation, and interleukin-17-mediated keratinocyte proliferation. Oleate stimulates P. acnes adhesion, keratinocyte proliferation, and comedogenesis via interleukin-1α release. Thus, diet

  12. Linking diet to acne metabolomics, inflammation, and comedogenesis: an update

    PubMed Central

    Melnik, Bodo C

    2015-01-01

    Acne vulgaris, an epidemic inflammatory skin disease of adolescence, is closely related to Western diet. Three major food classes that promote acne are: 1) hyperglycemic carbohydrates, 2) milk and dairy products, 3) saturated fats including trans-fats and deficient ω-3 polyunsaturated fatty acids (PUFAs). Diet-induced insulin/insulin-like growth factor (IGF-1)-signaling is superimposed on elevated IGF-1 levels during puberty, thereby unmasking the impact of aberrant nutrigenomics on sebaceous gland homeostasis. Western diet provides abundant branched-chain amino acids (BCAAs), glutamine, and palmitic acid. Insulin and IGF-1 suppress the activity of the metabolic transcription factor forkhead box O1 (FoxO1). Insulin, IGF-1, BCAAs, glutamine, and palmitate activate the nutrient-sensitive kinase mechanistic target of rapamycin complex 1 (mTORC1), the key regulator of anabolism and lipogenesis. FoxO1 is a negative coregulator of androgen receptor, peroxisome proliferator-activated receptor-γ (PPARγ), liver X receptor-α, and sterol response element binding protein-1c (SREBP-1c), crucial transcription factors of sebaceous lipogenesis. mTORC1 stimulates the expression of PPARγ and SREBP-1c, promoting sebum production. SREBP-1c upregulates stearoyl-CoA- and Δ6-desaturase, enhancing the proportion of monounsaturated fatty acids in sebum triglycerides. Diet-mediated aberrations in sebum quantity (hyperseborrhea) and composition (dysseborrhea) promote Propionibacterium acnes overgrowth and biofilm formation with overexpression of the virulence factor triglyceride lipase increasing follicular levels of free palmitate and oleate. Free palmitate functions as a “danger signal,” stimulating toll-like receptor-2-mediated inflammasome activation with interleukin-1β release, Th17 differentiation, and interleukin-17-mediated keratinocyte proliferation. Oleate stimulates P. acnes adhesion, keratinocyte proliferation, and comedogenesis via interleukin-1α release. Thus, diet

  13. Stressful Events and Serum Concentration of Substance P in Acne Patients

    PubMed Central

    Rokowska-Waluch, Anita; Cybulski, Marcin; Żurawski, Jakub; Kaczmarek, Mariusz; Michalak, Michał; Mojs, Ewa

    2016-01-01

    Background Psychological stress is an important factor of acne pathogenesis. Stress related production of hormones, cytokines and neuropeptides may result in the chronic course and exacerbations of the disease. Objective The aim of the study was to evaluate the relationship between acne severity, intensity of emotional stress and serum concentration of substance P (scSP), to compare the intensity of adversities, psychological stress and scSP in acne patients with healthy controls and to compare coping techniques for stress. Methods The study consisted of 80 patients. Emotional stress was analyzed with the use of social readjustment rating scale, whereas the methods of coping with stress were assessed with the coping inventory for stressful situation questionnaire. The blood concentration of substance P was analyzed by enzyme-linked immunosorbent assay method in a group of 40 patients with acne vulgaris and in control subjects. Results There was no statistically significant difference between the severity of acne and the intensity of stress. Acne patients presented a higher average scSP than the controls. No statistically significant correlation was observed between the severity of acne and scSP; however, the intensity of stress correlated with scSP in the control group. The evaluation of methods of coping with stress showed significantly higher rate for the avoidance-oriented coping among acne patients. Conclusion The number of stressful events is not a factor that determines the severity of acne. The course of the disease may depend on tolerance to stress and methods of coping with stress. PMID:27489429

  14. [New drugs for horses and production animals in 2011].

    PubMed

    Emmerich, I U

    2012-10-17

    In 2011, three newly developed active pharmaceutical ingredients for horses and food producing animals were released on the German market for veterinary drug products. Two of these new products represent different drug classes of antibiotics, the polypeptide antibiotic Bacitracin (Bacivet™) and the macrolide antibiotic Clorsulon (Levatum®). The third product represents an anticestodal antiparasitic (Tildipirosin, Zuprevo®). Furthermore, three established veterinary active pharmaceutical ingredients were modified to allow their application for additional species. Thus the nonsteroidal anti-inflammatory drug sodium salicylate is now additionally authorised for turkeys and both the macrolide antibiotic Tilmicosin and the anticoccidial drug Toltrazuril are currently available for sheep. Additionally, two veterinary drugs with a new formulation as well as a veterinary drug for horses and food producing animals with a resourceful new combination of active pharmaceutical ingredients have recently been released. PMID:23076759

  15. Football acne--an acneiform eruption.

    PubMed

    Farber, G A; Burks, J W; Hegre, A M; Brown, G R

    1977-09-01

    Football acne is a peculiar form of localized acneiform eruption of the chin that occurs in acne-prone individuals, as a result of the use of a protective chin strap under conditions of physical and emotional stress. Perhaps it is a locus minoris resistentiae phenomenon. The condition responds favorably to the removal of the chin strap and to the usual topical and systemic acne therapies. PMID:142615

  16. Acne keloidalis nuchae and tufted hair folliculitis.

    PubMed

    Luz Ramos, M; Muñoz-Pérez, M A; Pons, A; Ortega, M; Camacho, F

    1997-01-01

    Acne keloidalis nuchae is a chronic, scarring folliculitis that affects mostly black patients and is located on the back of the neck of young adults. The course is progressive and leads to hypertrophic scarring, chronic abscesses and hair loss. We discuss the relationship between acne keloidalis and tufted hair folliculitis, pointing out the possibility that tufted hair folliculitis is not a specific disease but secondary to other progressive folliculitis like folliculitis decalvans, dissecting cellulitis or acne keloidalis. PMID:9031798

  17. Acne: the role of medical nutrition therapy.

    PubMed

    Burris, Jennifer; Rietkerk, William; Woolf, Kathleen

    2013-03-01

    Acne is a common disease in Westernized nations, particularly among adolescents and young adults. Acne has substantial effects on quality of life, making treatment essential. Medical nutrition therapy as a potential treatment for acne is not new, although the literature examining diet and acne during the past 100 years is mixed. During the late 1800s and early 1900s, diet was commonly used as an adjunct treatment for acne. During the 1960s, however, the diet-acne connection fell out of favor. In recent years, dermatologists and registered dietitians have revisited the idea and become increasingly interested in the role of medical nutrition therapy in acne treatment. This article reviews the history and existing literature examining the association between diet and acne. Although the total number of studies conducted within the past 40 years is relatively small, the growing body of epidemiologic and experimental evidence suggests a relationship between diet and acne. Compared with other dietary factors, more research examines dietary glycemic load. The evidence is more convincing for high glycemic load diets, compared with other dietary factors. To date there are no randomized controlled trials investigating the relationship between frequent dairy or milk consumption and acne. Similarly, the number of research studies examining the relationship between dietary fat and/or n-3 fatty acids is sparse and the evidence is less robust. Taken together, several methodologic limitations need to be addressed, and additional research, preferably randomized controlled trials, is warranted before comprehensive evidence-based guidelines can be established. While dermatologists and registered dietitians continue to debate and research the potential relationship between diet and acne, the best dietary approach is to address each acne patient individually, carefully considering the possibility of dietary counseling. PMID:23438493

  18. Drug-device combination products: regulatory landscape and market growth.

    PubMed

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. PMID:26380388

  19. Pediatric Acne: Clinical Patterns and Pearls.

    PubMed

    Maroñas-Jiménez, Lidia; Krakowski, Andrew C

    2016-04-01

    Acne vulgaris presenting from birth to preadolescence can be confusing to diagnose and even more challenging to evaluate and manage. The differential diagnosis of acne varies by age and, in some cases (especially when it presents in midchildhood), deserves a thorough evaluation to rule out underlying systemic abnormalities. Acne management strategies, including factors affecting adherence to the treatment regimen, may be influenced by the patient's age. This article presents an overview of the clinical presentations of acne by age and our approach to evaluation and management of this common condition. PMID:27015779

  20. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of first aid antibiotic drug products. 333.150 Section 333.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE First Aid Antibiotic Drug Products §...

  1. 21 CFR 358.550 - Labeling of corn and callus remover drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of corn and callus remover drug products. 358.550 Section 358.550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Corn and Callus Remover Drug Products...

  2. Isotretinoin for acne and rosacea.

    PubMed

    Watson, Kendra D; Miest, Rachel Y; Tollefson, Megha M

    2016-06-01

    Isotretinoin is a revolutionary medicine for the treatment of acne vulgaris, with new studies showing evidence of excellent clinical outcomes in treating rosacea. After 30 years of clinical experience, new insights are being gained into dosing strategies, recurrence prevention, and dose-related side effects. Previous controversial associations with inflammatory bowel diseases and mood disorders have hampered the use of this medication in some clinical situations, with new evidence disproving these claims. The teratogenicity of this medication mandates iPLEDGE compliance with government regulations. Clinicians should be knowledgeable about this medication including its side effects, teratogenicity, and its controversies in order to adequately counsel patients, dissuade fears, and obtain the best clinical outcome when treating acne and rosacea. PMID:27416313

  3. Important controversies associated with isotretinoin therapy for acne.

    PubMed

    Wolverton, Stephen E; Harper, Julie C

    2013-04-01

    Isotretinoin is a remarkably effective drug for severe, recalcitrant acne vulgaris. Soon after the drug's release in the early 1980s, a number of important adverse effects were reported subsequently leading to a variety of medical and medicolegal controversies. Three of these controversies will be highlighted concerning the putative role of isotretinoin in (1) depression and suicide, (2) inflammatory bowel disease, and (3) iPledge and pregnancy prevention programs. It appears that a very small subset of patients receiving isotretinoin for acne are at risk for depression, which is very manageable provided there is adequate patient awareness of the possibility, maximum communication between the patient and physician, and cessation of therapy if clinically important depression occurs (after which the depression rapidly resolves in a week or less). Multiple controlled studies actually suggest a very favorable effect of isotretinoin on depression and anxiety common in the population requiring isotretinoin. With regard to inflammatory bowel disease, in just one study, only ulcerative colitis association with isotretinoin reached statistical significance. The actual incidence of this association is strikingly low. Finally, it is clear that even the most recent pregnancy prevention program (iPledge) is no more successful than prior programs; there will likely always be a small number of female patients becoming pregnant while receiving isotretinoin for acne vulgaris. PMID:23559397

  4. Natural Products as a Foundation for Drug Discovery

    PubMed Central

    Beutler, John A.

    2009-01-01

    Natural products have contributed to the development of many drugs for diverse indications. While most U.S. pharmaceutical companies have reduced or eliminated their in-house natural product groups, new paradigms and new enterprises have evolved to carry on a role for natural products in the pharmaceutical industry. Many of the reasons for the decline in popularity of natural products are being addressed by the development of new techniques for screening and production. This overview aims to inform pharmacologists of current strategies and techniques that make natural products a viable strategic choice for inclusion in drug discovery programs. PMID:20161632

  5. Advancing the Care of Post-Acne Scarring: Expert Insights Into New Treatment Options.

    PubMed

    Werschler, Wm Philip; Few, Julius W; Jacob, Carolyn I; Joseph, John H; Spencer, James M; Taub, Amy Forman

    2016-05-01

    Most patients with acne have some degree of facial scarring even after their acne resolves, extending the period of psychosocial distress. Unfortunately, management of acne scars remains challenging. Many treatments for post-acne scarring including chemical peels, skin needling, laser resurfacing, surgical repair, subcision lifting, and punch elevation lifting, are limited by moderate and unpredictable results, significant morbidity, and substantial patient investments in time and money. The most recent addition to the armamentarium is tissue augmentation with soft tissue fillers, including a recently approved polymethylmethacrylate-collagen filler. Matching individual patient needs to the appropriate treatment is crucial. While many patients with acne scars have unrealistic expectations about treatment outcomes, open, honest, and realistic dialogue regarding their treatment options and concerns can facilitate realistic expectations. This article is based on a consensus discussion by the authors, who all have experience managing post-acne scarring, as well as the content of a series of live CME-accredited symposia in connection with major dermatology meetings.

    J Drugs Dermatol. 2016;15(5):518-525. PMID:27168260

  6. Comparison effect of azithromycin gel 2% with clindamycin gel 1% in patients with acne

    PubMed Central

    Mokhtari, Fatemeh; Faghihi, Gita; Basiri, Akram; Farhadi, Sadaf; Nilforoushzadeh, Mohammadali; Behfar, Shadi

    2016-01-01

    Background: Acne vulgaris is the most common skin disease. Local and systemic antimicrobial drugs are used for its treatment. But increasing resistance of Propionibacterium acnes to antibiotics has been reported. Materials and Methods: In a double-blind clinical trial, 40 patients with mild to moderate acne vulgaris were recruited. one side of the face was treated with Clindamycin Gel 1% and the other side with Azithromycin Topical Gel 2% BID for 8 weeks and then they were assessed. Results: Average age was 21. 8 ± 7 years. 82.5% of them were female. Average number of papules, pustules and comedones was similarly reduced in both groups and, no significant difference was observed between the two groups (P > 0.05, repeated measurs ANOVA). The mean indexes of ASI and TLC also significantly decreased during treatment in both groups, no significant difference was observed between the two groups. (P > 0.05, repeated measurs ANOVA). Also, impact of both drugs on papules and pustules was 2-3 times greater than the effect on comedones. Average satisfaction score was not significant between the two groups (P = 0.6, repeated measurs ANOVA). finally, frequency distribution of complications was not significant between the two groups (P > 0.05, Fisher Exact test). Conclusion: Azithromycin gel has medical impact at least similar to Clindamycin Gel in treatment of mild to moderate acne vulgaris, and it may be consider as suitable drug for resistant acne to conventional topical therapy. PMID:27169103

  7. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for......

  8. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological... drug or human biological product is eligible for extension, the term shall be extended by the time...

  9. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological... drug or human biological product is eligible for extension, the term shall be extended by the time...

  10. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological... drug or human biological product is eligible for extension, the term shall be extended by the time...

  11. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological... drug or human biological product is eligible for extension, the term shall be extended by the time...

  12. 37 CFR 1.775 - Calculation of patent term extension for a human drug, antibiotic drug or human biological product.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... extension for a human drug, antibiotic drug or human biological product. 1.775 Section 1.775 Patents... Review § 1.775 Calculation of patent term extension for a human drug, antibiotic drug or human biological... drug or human biological product is eligible for extension, the term shall be extended by the time...

  13. [New drugs for horses and production animals in 2015].

    PubMed

    Emmerich, Ilka Ute

    2016-06-16

    In 2015, four newly developed active pharmaceutical ingredients for horses and food-producing animals were released on the German market for veterinary drug products. These were the bisphosphonate Clodronic Acid (Osphos®), the 5-hydroxytryptamine (2A) receptor antagonist Ketanserin (Vulketan®), the aminoglycoside antibiotic Paromomycin (Parofor®) and the antibiotic Thiamphenicol (TAF Spray®) from the fenicole group. With Chlorphenamine, a temporary not available active ingredient was reapproved in a new drug. Furthermore, three veterinary drugs with a new formulation as well as one product with a new strength and two products with a new combination of active pharmaceutical ingredients have been launched. PMID:27223124

  14. Dissecting the taxonomic heterogeneity within Propionibacterium acnes: proposal for Propionibacterium acnes subsp. acnes subsp. nov. and Propionibacterium acnes subsp. elongatum subsp. nov.

    PubMed

    Dekio, Itaru; Culak, Renata; Misra, Raju; Gaulton, Tom; Fang, Min; Sakamoto, Mitsuo; Ohkuma, Moriya; Oshima, Kenshiro; Hattori, Masahira; Klenk, Hans-Peter; Rajendram, Dunstan; Gharbia, Saheer E; Shah, Haroun N

    2015-12-01

    Propionibacterium acnes subsp. acnes subsp. nov. and Propionibacterium acnes subsp. elongatum subsp. nov. are described. These emanate from the three known phylotypes of P. acnes, designated types I, II and III. Electron microscopy confirmed the filamentous cell shape of type III, showing a striking difference from types I/II, which were short rods. Biochemical tests indicated that, in types I/II, either the pyruvate, l-pyrrolidonyl arylamidase or d-ribose 2 test was positive, whereas all of these were negative among type III strains. Matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) spectra, which profile mainly their ribosomal proteins, were different between these two groups. Surface-enhanced laser-desorption/ionization time-of-flight mass spectrometry (SELDI-TOF MS) spectra of all phylotypes revealed a specific protein biomarker that was overexpressed in type III strains compared with types I/II only when grown aerobically. Reference strains had high whole-genome similarity between types I (>91 %) and II (>75 %), but a considerably lower level of 72 % similarity with type III. recA and gyrB sequence dendrograms confirmed the distant relatedness of type III, indicating the presence of two distinct centres of variation within the species P. acnes. On the other hand, cellular fatty acid profiles and 16S rRNA gene sequence relatedness (>99.3 %) circumscribed the species. Thus, we propose two subspecies, Propionibacterium acnes subsp. acnes subsp. nov. for types I/II and Propionibacterium acnes subsp. elongatum subsp. nov. for type III. The type strain of Propionibacterium acnes subsp. acnes is NCTC 737T ( = ATCC 6919T = JCM 6425T = DSM 1897T = CCUG 1794T), while the type strain of Propionibacterium acnes subsp. elongatum is K124T ( = NCTC 13655T = JCM 18919T). PMID:26432704

  15. United States Food and Drug Administration Product Label Changes.

    PubMed

    Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  16. United States Food and Drug Administration Product Label Changes

    PubMed Central

    Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

    2016-01-01

    Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

  17. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., Oct. 15, 2004, the limitation of the enhanced duration claim to 24 hours (21 CFR 350.50 (b)(3) and (b... Section 350.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... states “underarm” . (2) The labeling may state “also underarm due to stress”. (3) For products...

  18. 21 CFR 350.50 - Labeling of antiperspirant drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., Oct. 15, 2004, the limitation of the enhanced duration claim to 24 hours (21 CFR 350.50 (b)(3) and (b... Section 350.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... states “underarm” . (2) The labeling may state “also underarm due to stress”. (3) For products...

  19. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Administration. New chemical entity means a drug that contains no active moiety that has been approved by FDA in...) application. (1) (2) If a drug product that contains a new chemical entity was approved after September 24... contains the same active moiety as in the new chemical entity for a period of 5 years from the date...

  20. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Administration. New chemical entity means a drug that contains no active moiety that has been approved by FDA in...) application. (1) (2) If a drug product that contains a new chemical entity was approved after September 24... contains the same active moiety as in the new chemical entity for a period of 5 years from the date...

  1. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Administration. New chemical entity means a drug that contains no active moiety that has been approved by FDA in...) application. (1) (2) If a drug product that contains a new chemical entity was approved after September 24... contains the same active moiety as in the new chemical entity for a period of 5 years from the date...

  2. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Administration. New chemical entity means a drug that contains no active moiety that has been approved by FDA in...) application. (1) (2) If a drug product that contains a new chemical entity was approved after September 24... contains the same active moiety as in the new chemical entity for a period of 5 years from the date...

  3. 21 CFR 349.50 - Labeling of ophthalmic drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of...

  4. 21 CFR 349.50 - Labeling of ophthalmic drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of...

  5. 21 CFR 349.50 - Labeling of ophthalmic drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of...

  6. 21 CFR 349.50 - Labeling of ophthalmic drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of...

  7. Tailoring individualized treatment plans for acne.

    PubMed

    Harper, Julie C

    2008-01-01

    Because acne is a complex multifactorial disorder, combination treatment may be required to target its various pathogenic factors. Combination treatments also offer the most improvement over the shortest time. Oral contraceptives (OCs) are an excellent treatment, and clinicians should consider them a first-line option as part of combination therapy in women with acne. PMID:18338655

  8. [Back pain and acne conglobata: SAPHO syndrome].

    PubMed

    Kühn, F; Fehr, S; Stoll, T

    2007-04-11

    We report on a young woman suffering from SAPHO syndrome with back pain and arthritis of the sternoclavicular joints. This inflammatory disorder of the osteoarticular system (synovitis, osteitis, and hyperostosis) is associated with severe acne or palmoplantar pustulosis. The patient was treated with pamidronate, NSAID and physiotherapy which improved the musculoskeletal symptoms completely. The acne was treated with isotretinoin. PMID:17506389

  9. ANTHOCYANIN (ACN) STABILITY IN CELL CULTURE MEDIA

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Anthocyanins (ACNs) are potential oxygen radical scavengers that have coronary vasoactive and vasoprotective properties. Cell or tissue culture systems have been used to examine the bioactivity and mechanisms of action of ACNs on the vascular system. However, due to their unique chemical structure, ...

  10. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Magnesium sulfate heptahydrate; label declaration on drug products. 201.312 Section 201.312 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products....

  11. Pharmacokinetic/pharmacodynamic studies in drug product development.

    PubMed

    Meibohm, Bernd; Derendorf, Hartmut

    2002-01-01

    In the quest of ways for rationalizing and accelerating drug product development, integrated pharmacokinetic/pharmacodynamic (PK/PD) concepts provide a highly promising tool. PK/PD modeling concepts can be applied in all stages of preclinical and clinical drug development, and their benefits are multifold. At the preclinical stage, potential applications might comprise the evaluation of in vivo potency and intrinsic activity, the identification of bio-/surrogate markers, as well as dosage form and regimen selection and optimization. At the clinical stage, analytical PK/PD applications include characterization of the dose-concentration-effect/toxicity relationship, evaluation of food, age and gender effects, drug/drug and drug/disease interactions, tolerance development, and inter- and intraindividual variability in response. Predictive PK/PD applications can also involve extrapolation from preclinical data, simulation of drug responses, as well as clinical trial forecasting. Rigorous implementation of the PK/PD concepts in drug product development provides a rationale, scientifically based framework for efficient decision making regarding the selection of potential drug candidates, for maximum information gain from the performed experiments and studies, and for conducting fewer, more focused clinical trials with improved efficiency and cost effectiveness. Thus, PK/PD concepts are believed to play a pivotal role in streamlining the drug development process of the future. PMID:11782894

  12. Hepatitis B, interferon, and acne fulminans in a young girl

    PubMed Central

    Arora, Sandeep; Malik, Ajay; Kumar, Dharmendra; Sodhi, Neha

    2016-01-01

    Acne fulminans (AF) is a very rare severe form of acne seen in young males, characterized by a sudden and explosive onset of hemorrhagic pustules and ulceration on the trunk, systemic features in the form of fever, polyarthropathy, malaise, erythema nodosum and painful osteolytic bone involvement with leukocytosis, and an elevated erythrocyte sedimentation rate. Conventional treatment of AF includes corticosteroids or immunosuppressive agents for the initial phase followed by isotretinoin. Active hepatitis B infection with a high viral load precludes the administration of any immunosuppressive drugs. We present the case of an 18-year-old girl with a history of occasional acne who presented with AF of sudden onset following administration of interferon-alpha-2a for her recently detected hepatitis B infection. Management of hepatitis B was withheld in view of her general condition. The patient was managed with low dose isotretinoin with subsidence of lesions. AF in a young female precipitated by interferon and its management with isotretinoin in the presence of active hepatitis B infection make the case unique. PMID:27057488

  13. Hepatitis B, interferon, and acne fulminans in a young girl.

    PubMed

    Arora, Sandeep; Malik, Ajay; Kumar, Dharmendra; Sodhi, Neha

    2016-01-01

    Acne fulminans (AF) is a very rare severe form of acne seen in young males, characterized by a sudden and explosive onset of hemorrhagic pustules and ulceration on the trunk, systemic features in the form of fever, polyarthropathy, malaise, erythema nodosum and painful osteolytic bone involvement with leukocytosis, and an elevated erythrocyte sedimentation rate. Conventional treatment of AF includes corticosteroids or immunosuppressive agents for the initial phase followed by isotretinoin. Active hepatitis B infection with a high viral load precludes the administration of any immunosuppressive drugs. We present the case of an 18-year-old girl with a history of occasional acne who presented with AF of sudden onset following administration of interferon-alpha-2a for her recently detected hepatitis B infection. Management of hepatitis B was withheld in view of her general condition. The patient was managed with low dose isotretinoin with subsidence of lesions. AF in a young female precipitated by interferon and its management with isotretinoin in the presence of active hepatitis B infection make the case unique. PMID:27057488

  14. Insulin resistance in severe acne vulgaris

    PubMed Central

    Cengiz, Fatma Pelin; Kemeriz, Funda

    2015-01-01

    Introduction Acne vulgaris is a pilosebaceous gland disease that usually affects people from puberty to young adulthood. It is seen especially on the face, neck, trunk and arms. Its severity differs from patient to patient and its pathogenesis is multifactorial. The main pathogenic factors of acne are high sebaceous gland secretion, follicular hyperproliferation, high androgen effects, propionibacterium acnes colonization and inflammation. Diet is always thought a probable reason for acne and many studies are done about acne and diet. Aim To determine the effect of insulin resistance in severe acne vulgaris. Material and methods Two hundred and forty-three acne vulgaris patients and 156 healthy controls were enrolled into the study. The blood levels of insulin and glucose were measured. Homeostasis Model Assessment (HOMA) Index was calculated. The values were compared with the control group. Results All of the patients were in the severe acne group according to their scores on the global acne scoring scale. While fasting blood glucose levels were not different between the groups (p > 0.05, 82.91 ±9.76 vs. 80.26 ±8.33), the fasting insulin levels were significantly higher in the patient group than in the control group (p < 0.001, 14.01 ±11.94 vs. 9.12 ±3.53). Additionally, there was a highly significant difference between the patient and control groups in terms of HOMA values (p < 0.001, 2.87 ±2.56 vs. 1.63 ±0.65). Conclusions These results suggest that insulin resistance may have a role in the pathogenesis of acne. PMID:26366152

  15. Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study

    PubMed Central

    Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

    2016-01-01

    Background Because vital details of potential pharmacokinetic drug-drug interactions are often described in free-text structured product labels, manual curation is a necessary but expensive step in the development of electronic drug-drug interaction information resources. The use of nonexperts to annotate potential drug-drug interaction (PDDI) mentions in drug product label annotation may be a means of lessening the burden of manual curation. Objective Our goal was to explore the practicality of using nonexpert participants to annotate drug-drug interaction descriptions from structured product labels. By presenting annotation tasks to both pharmacy experts and relatively naïve participants, we hoped to demonstrate the feasibility of using nonexpert annotators for drug-drug information annotation. We were also interested in exploring whether and to what extent natural language processing (NLP) preannotation helped improve task completion time, accuracy, and subjective satisfaction. Methods Two experts and 4 nonexperts were asked to annotate 208 structured product label sections under 4 conditions completed sequentially: (1) no NLP assistance, (2) preannotation of drug mentions, (3) preannotation of drug mentions and PDDIs, and (4) a repeat of the no-annotation condition. Results were evaluated within the 2 groups and relative to an existing gold standard. Participants were asked to provide reports on the time required to complete tasks and their perceptions of task difficulty. Results One of the experts and 3 of the nonexperts completed all tasks. Annotation results from the nonexpert group were relatively strong in every scenario and better than the performance of the NLP pipeline. The expert and 2 of the nonexperts were able to complete most tasks in less than 3 hours. Usability perceptions were generally positive (3.67 for expert, mean of 3.33 for nonexperts). Conclusions The results suggest that nonexpert annotation might be a feasible option for comprehensive

  16. Stability profiles of drug products extended beyond labeled expiration dates.

    PubMed

    Lyon, Robbe C; Taylor, Jeb S; Porter, Donna A; Prasanna, Hullahalli R; Hussain, Ajaz S

    2006-07-01

    The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This program probably contains the most extensive source of pharmaceutical stability data extant. This report summarizes extended stability profiles for 122 different drug products (3,005 different lots). The drug products were categorized into five groups based on incidence of initial extension failures and termination failures (extended lot eventually failed upon re-testing). Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. The SLEP data supports the assertion that many drug products, if properly stored, can be extended past the expiration date. Due to the lot-to-lot variability, the stability and quality of extended drug products can only be assured by periodic testing and systematic evaluation of each lot. PMID:16721796

  17. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on...

  18. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on...

  19. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on...

  20. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on...

  1. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on...

  2. Lessons from innovation in drug-device combination products.

    PubMed

    Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

    2012-01-01

    Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. PMID:22200650

  3. A Historical Overview of Natural Products in Drug Discovery

    PubMed Central

    Dias, Daniel A.; Urban, Sylvia; Roessner, Ute

    2012-01-01

    Historically, natural products have been used since ancient times and in folklore for the treatment of many diseases and illnesses. Classical natural product chemistry methodologies enabled a vast array of bioactive secondary metabolites from terrestrial and marine sources to be discovered. Many of these natural products have gone on to become current drug candidates. This brief review aims to highlight historically significant bioactive marine and terrestrial natural products, their use in folklore and dereplication techniques to rapidly facilitate their discovery. Furthermore a discussion of how natural product chemistry has resulted in the identification of many drug candidates; the application of advanced hyphenated spectroscopic techniques to aid in their discovery, the future of natural product chemistry and finally adopting metabolomic profiling and dereplication approaches for the comprehensive study of natural product extracts will be discussed. PMID:24957513

  4. 21 CFR 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. 1310.11 Section 1310.11 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES § 1310.11 Reinstatement of exemption for...

  5. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 556, and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole...: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing...

  6. NATURAL PRODUCTS: A CONTINUING SOURCE OF NOVEL DRUG LEADS

    PubMed Central

    Cragg, Gordon M.; Newman, David J.

    2013-01-01

    1. Background Nature has been a source of medicinal products for millennia, with many useful drugs developed from plant sources. Following discovery of the penicillins, drug discovery from microbial sources occurred and diving techniques in the 1970s opened the seas. Combinatorial chemistry (late 1980s), shifted the focus of drug discovery efforts from Nature to the laboratory bench. 2. Scope of Review This review traces natural products drug discovery, outlining important drugs from natural sources that revolutionized treatment of serious diseases. It is clear Nature will continue to be a major source of new structural leads, and effective drug development depends on multidisciplinary collaborations. 3. Major Conclusions The explosion of genetic information led not only to novel screens, but the genetic techniques permitted the implementation of combinatorial biosynthetic technology and genome mining. The knowledge gained has allowed unknown molecules to be identified. These novel bioactive structures can be optimized by using combinatorial chemistry generating new drug candidates for many diseases. 4 General Significance: The advent of genetic techniques that permitted the isolation / expression of biosynthetic cassettes from microbes may well be the new frontier for natural products lead discovery. It is now apparent that biodiversity may be much greater in those organisms. The numbers of potential species involved in the microbial world are many orders of magnitude greater than those of plants and multi-celled animals. Coupling these numbers to the number of currently unexpressed biosynthetic clusters now identified (>10 per species) the potential of microbial diversity remains essentially untapped. PMID:23428572

  7. Combination topical therapy in the treatment of acne.

    PubMed

    Del Rosso, James Q

    2006-08-01

    Many medications are available for the management of acne. The armamentarium includes topical retinoids (ie, adapalene, tazarotene, tretinoin), antimicrobial and antibacterial agents (ie, benzoyl peroxide, clindamycin, erythromycin, sulfacetamide with or without sulfur), oral antibiotics (ie, doxycycline, minocycline, tetracycline), hormonal agents (ie, oral contraceptives, spironolactone), and systemic retinoids (ie, isotretinoin). Acne usually is treated with combination therapy to address its multifactorial pathophysiology. The combination of clindamycin 1%-benzoyl peroxide 5% gel, available as a stable formulation in a single tube, is efficacious and well-tolerated. The product's excipients, glycerin and dimethicone, minimize treatment-related irritation, thereby increasing patient compliance. Clindamycin-benzoyl peroxide may be well-tolerated when applied with topical retinoids, creating a more targeted and complete treatment strategy. PMID:17966494

  8. New natural products as new leads for antibacterial drug discovery.

    PubMed

    Brown, Dean G; Lister, Troy; May-Dracka, Tricia L

    2014-01-15

    Natural products have been a rich source of antibacterial drugs for many decades, but investments in this area have declined over the past two decades. The purpose of this review article is to provide a recent survey of new natural product classes and the mechanisms by which they work. PMID:24388805

  9. A look at emerging delivery systems for topical drug products.

    PubMed

    Fireman, Sharon; Toledano, Ofer; Neimann, Karine; Loboda, Natalia; Dayan, Nava

    2011-01-01

    The introduction of new topical drugs based on new chemical entities has become a rare event. Instead, pharmaceutical companies have been focused on reformulating existing drugs resulting in an ever-growing number of topical drug products for every approved drug substance. In light of this trend, soon reformulations may not be as rewarding to their sponsors as they are today unless they offer a substantial improvement over other formulations of the same drug substance and the same indication, namely improved efficacy over existing drugs, reduced side effects, unique drug combinations, or applicability for new indications. This article reviews and compares topical drug delivery systems currently under active research that are designed to offer such advantages in the coming years. The reviewed delivery systems are: liposomes, niosomes, transferosomes, ethosomes, solid lipid nanoparticles, nanostructured lipid carriers, cyclodextrin, and sol-gel microcapsules. Among all the topical drug delivery systems currently undergoing active research, only the sol-gel microencapsulation is at clinical stages. PMID:22353154

  10. Update and future of systemic acne treatment.

    PubMed

    Zouboulis, Christos C; Piquero-Martin, Jaime

    2003-01-01

    Systemic treatment is required in patients with moderate-to-severe acne, especially when acne scars start to occur. Antibiotics with anti-inflammatory properties, such as tetracyclines (oxytetracycline, tetracycline chloride, doxycycline, minocycline and limecycline) and macrolide antibiotics (erythromycin and azithromycin) are the agents of choice for papulopustular acne, even though the emerging resistant bacterial strains are minimizing their effect, especially regarding erythromycin. Systemic antibiotics should be administered during a period of 8-12 weeks. In severe papulopustular and in nodulocystic/conglobate acne, oral isotretinoin is the treatment of choice. Hormonal treatment represents an alternative regimen in female acne, whereas it is mandatory in resistant, severe pubertal or post-adolescent forms of the disease. Compounds with anti-androgenic properties include estrogens combined with progestins, such as ethinyl estradiol with cyproterone acetate, chlormadinone acetate, desogestrel, drospirenone, levonogestrel, norethindrone acetate, norgestimate, and other anti-androgens directly blocking the androgen receptor (flutamide) or inhibiting androgen activity at various levels, corticosteroids, spironolactone, cimetidine, and ketoconazole. After 3 months of treatment control of seborrhea and acne can be obtained. Low-dose corticosteroids (prednisone, prednisolone, or dexamethasone) are indicated in patients with adrenal hyperandrogenism or acne fulminans. New developments and future trends represent low-dose long-term isotretinoin regimens, new isotretinoin formulations (micronized isotretinoin), isotretinoin metabolites, combination treatments to reduce toxicity, insulin-sensitizing agents, 5alpha-reductase type 1 inhibitors, antisense oligonucleotide molecules, and, especially, new anti-inflammatory agents, such as lipoxygenase inhibitors. PMID:12566804

  11. [Effective and safe pharmacotherapy of acne vulgaris and treatment of sun-damaged skin].

    PubMed

    Fendrich, Z; Jandová, E; Finsterlová, M

    2000-03-01

    An inevitable condition for the pharmacist is a basic knowledge of dermatological changes which are prominent in acne and solar impairment of the skin to be able to recommend in a qualified manner an effective and safe treatment to the patient. However, sufferers of the more serious forms of acne should always be referred to their general practitioner, or preferentially a dermatologist. Acne vulgaris is an androgen-induced disorder, but three major mechanisms for the development of the disease have been identified: hypertrophy of the sebaceous gland, hyperkatosis of the follicular epithelium, and proliferation of microbial flora, particularly Propionibacterium acnes. The basis of all lesions is the microcomedone which is developed into the ripe comedone. Inflammatory lesions are thought to be due to proliferation of P. acnes. In the selfmedication of common acne, benzoyl peroxide, which in a 5-10% lotion exerts antimicrobial and keratolytic properties, proved to be useful. Patients appreciate a lot its instant effect which is visible after just one day of treatment. Salicylic acid is another effective drug, which, when used on the long-term basis, has comedolytic properties; it reduces the number of microcomedones and counteracts plugging of the follicles. In addition, in healthy young women who take oral contraception, a triphasic combined oral preparations of contraceptives with newer progestins, notably with norgestimmate, which is practically free of androgenic effects, are recommended with advantage for the treatment of moderate acne vulgaris without any adverse effects. Solar impairment of the skin, the so-called solar ageing, is clinically indistinguishable from biological ageing. Changes connected with solar impairment appear mostly in the dermis, where solar elastosis develops, the skin gets drier and wrinkle formation appears. For the treatment, hydroxy acids are recommended, namely salicylic acid, which is very effective, because in combination with a

  12. Efficacy of fixed daily 20 mg of isotretinoin in moderate to severe scar prone acne

    PubMed Central

    Rasi, Abbas; Behrangi, Elham; Rohaninasab, Masoumeh; Nahad, Zahra Mehr

    2014-01-01

    Background: Despite advances in acne therapy in recent years, treatment failure is common. Isotretinoin is the only drug that affects almost all factors in acne pathogenesis, but side-effects are common at the doses reported in published studies in the literature. The aim of this study was to investigate the efficacy of low daily dose isotretinoin in moderate to severe acne patients. The secondary objective was to measure the rate of relapse 5 years after the completion of therapy. Materials and Methods: In this retrospective, noncomparative study, 146 patients with moderate to severe scare prone acne. Treatment regimen consisted of isotretinoin, fixed 20 mg daily, and duration of treatment-based on the weight of patient, until total cumulative dose of 120 mg/kg of body weight is achieved. No topical or other systemic therapy was allowed during the trial. Liver function tests (serum glutamic-oxalocetic transaminase, serum glutamate pyruvate transaminase, direct and total bilirubin), and lipid profiles (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglyceride) were evaluated for all patients, before the initiation of treatment and again after the 2nd month of treatment. All data analyzed by Microsoft Office Excel 2007; in descriptive statics frequency and SPSS.18 software. Results: At the end of treatment course, (96.4%) demonstrated complete clearing of their acne, defined as no acne or occasional isolated lesions. In 5-year follow-up, relapse accrued in 11 (7.9%) of patients. All adverse effects were mild, and discontinuation of treatment was not necessary. Conclusion: Low dose isotretinoin was found to be a safe and effective choice for patients with moderate to severe scar prone acne vulgaris. PMID:24804178

  13. The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety.

    PubMed

    Woo, J; Wolfgang, S; Batista, H

    2008-03-01

    Americans benefit from one of the safest drug supplies and one of the highest standards of consumer protection in the world. Over the past decade, though, a general trend toward globalization of the supply chains for finished pharmaceutical products and active pharmaceutical ingredients has created new challenges for the Food and Drug Administration (FDA) in ensuring the safety and quality of the drug supply. Explosive growth in pharmaceutical manufacturing for the US market is particularly evident in the developing regions of Asia. Manufacturing sites in China and India now comprise approximately 40% of all FDA-registered foreign sites, having increased from 30% in 2002. (In 2001, when legislation first went into effect requiring registration of all foreign drug manufacturing sites, 140 registered sites in China listed 797 drug items for potential importation; as of 1 October 2007, that number had grown to 815 registered sites and well over 3,000 listed items.) In total in 2006, the United States received >145,000 line entries of imported drug products from >160 countries, up from only 1,300 line entries in 2000. FDA regulatory oversight resources (e.g., those allocated to inspection and testing of imports) are being challenged to keep up with the explosive growth of imported drugs. (In 2006, the FDA performed inspections at 212 foreign drug firms. This number has remained relatively consistent over the past 6 years, starting at 249 in 2001 and ranging from 190 to 260 on an annual basis.) PMID:18253142

  14. Cell culture media impact on drug product solution stability.

    PubMed

    Purdie, Jennifer L; Kowle, Ronald L; Langland, Amie L; Patel, Chetan N; Ouyang, Anli; Olson, Donald J

    2016-07-01

    To enable subcutaneous administration of monoclonal antibodies, drug product solutions are often needed at high concentrations. A significant risk associated with high drug product concentrations is an increase in aggregate level over the shelf-life dating period. While much work has been done to understand the impact of drug product formulation on aggregation, there is limited understanding of the link between cell culture process conditions and soluble aggregate growth in drug product. During cell culture process development, soluble aggregates are often measured at harvest using cell-free material purified by Protein A chromatography. In the work reported here, cell culture media components were evaluated with respect to their impact on aggregate levels in high concentration solution drug product during accelerated stability studies. Two components, cysteine and ferric ammonium citrate, were found to impact aggregate growth rates in our current media (version 1) leading to the development of new chemically defined media and concentrated feed formulations. The new version of media and associated concentrated feeds (version 2) were evaluated across four cell lines producing recombinant IgG4 monoclonal antibodies and a bispecific antibody. In all four cell lines, the version 2 media reduced aggregate growth over the course of a 12 week accelerated stability study compared with the version 1 media, although the degree to which aggregate growth decreased was cell line dependent. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:998-1008, 2016. PMID:27111574

  15. [Roaccutan in the therapy of severe manifestations of acne vulgaris and rosacea].

    PubMed

    Gromova, S A; Samgin, M A; Kolesnikov, Iu Iu

    1989-01-01

    Roakkutan was used in the treatment of 49 patients with severe acne vulgaris and 8 patients with rosacea. The treatment was highly effective. The primary and maintenance daily doses of the drug are suggested and the terms of therapy defined. PMID:2534455

  16. Light and laser therapy for acne: sham or science? facts and controversies.

    PubMed

    Webster, Guy F

    2010-01-01

    It has long been known that light is helpful in acne. Teens recognize that summer sun diminishes pimples, and wise pharmaceutical companies (which is limiting) know that a drug trial ending in sunny months will have an elevated placebo response. PMID:20082947

  17. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product...

  18. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product...

  19. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product...

  20. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product...

  1. New Perspectives on Antiacne Plant Drugs: Contribution to Modern Therapeutics

    PubMed Central

    Yadav, Narayan Prasad

    2014-01-01

    Acne is a common but serious skin disease, which affects approximately 80% adolescents and young adults in 11–30 age group. 42.5% of men and 50.9% of women continue to suffer from this disease into their twenties. Bacterial resistance is now at the alarming stage due to the irrational use of antibiotics. Hence, search for new lead molecule/bioactive and rational delivery of the existing drug (for better therapeutic effect) to the site of action is the need of the hour. Plants and plant-derived products have been an integral part of health care system since time immemorial. Therefore, plants that are currently used for the treatment of acne and those with a high potential are summarized in the present review. Most active plant extracts, namely, P. granatum, M. alba, A. anomala, and M. aquifolium exhibit minimum inhibitory concentration (MIC) in the range of 4–50 µg/mL against P. acnes, while aromatic oils of C. obovoides, C. natsudaidai, C. japonica, and C. nardus possess MICs 0.005–0.6 μL/mL and phytomolecules such as rhodomyrtone, pulsaquinone, hydropulsaquinone, honokiol, magnolol, xanthohumol lupulones, chebulagic acid and rhinacanthin-C show MIC in the range of 0.5–12.5 μg/mL. Novel drug delivery strategies of important plant leads in the treatment of acne have also been discussed. PMID:25147793

  2. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... EMISSION TOMOGRAPHY DRUGS Records § 212.110 How must I maintain records of my production of PET drugs? (a) Record availability. Records must be maintained at the PET drug production facility or another...

  3. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... EMISSION TOMOGRAPHY DRUGS Records § 212.110 How must I maintain records of my production of PET drugs? (a) Record availability. Records must be maintained at the PET drug production facility or another...

  4. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... EMISSION TOMOGRAPHY DRUGS Records § 212.110 How must I maintain records of my production of PET drugs? (a) Record availability. Records must be maintained at the PET drug production facility or another...

  5. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Magnesium sulfate heptahydrate; label declaration on drug products. 201.312 Section 201.312 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Specific Labeling Requirements for Specific Drug Products § 201.312 Magnesium...

  6. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... EMISSION TOMOGRAPHY DRUGS Records § 212.110 How must I maintain records of my production of PET drugs? (a) Record availability. Records must be maintained at the PET drug production facility or another...

  7. 21 CFR 348.50 - Labeling of external analgesic drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of external analgesic drug products. 348.50 Section 348.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN...

  8. Marine Natural Products: A Way to New Drugs

    PubMed Central

    2009-01-01

    The investigation of marine natural products (low molecular weight bioregulators) is a rapidly developing scientific field at the intersection of biology and chemistry. Investigations aimed at detecting, identifying, and understanding the structure of marine natural products have led to the discovery of 20,000 new substances, including those characterized by an extremely high physiological activity. Some results and prospects of works aimed at creating new drugs on the basis of marine natural products are discussed herein. PMID:22649599

  9. Hormonal treatment of acne vulgaris: an update

    PubMed Central

    Elsaie, Mohamed L

    2016-01-01

    Acne vulgaris is a common skin condition associated with multiple factors. Although mostly presenting alone, it can likewise present with features of hyperandrogenism and hormonal discrepancies. Of note, hormonal therapies are indicated in severe, resistant-to-treatment cases and in those with monthly flare-ups and when standard therapeutic options are inappropriate. This article serves as an update to hormonal pathogenesis of acne, discusses the basics of endocrinal evaluation for patients with suspected hormonal acne, and provides an overview of the current hormonal treatment options in women. PMID:27621661

  10. Hormonal treatment of acne vulgaris: an update.

    PubMed

    Elsaie, Mohamed L

    2016-01-01

    Acne vulgaris is a common skin condition associated with multiple factors. Although mostly presenting alone, it can likewise present with features of hyperandrogenism and hormonal discrepancies. Of note, hormonal therapies are indicated in severe, resistant-to-treatment cases and in those with monthly flare-ups and when standard therapeutic options are inappropriate. This article serves as an update to hormonal pathogenesis of acne, discusses the basics of endocrinal evaluation for patients with suspected hormonal acne, and provides an overview of the current hormonal treatment options in women. PMID:27621661

  11. Neglected aspects in the management of acne.

    PubMed

    Gordon, B

    1985-01-01

    Acne is the result of excessive grease on the skin. The successful treatment of acne depends essentially on the degreasing of the skin to an extent which produces peeling, which is the observable index of adequate treatment. The use of antibiotics is supplementary to degreasing and peeling. Degreasing is best achieved by thrice daily washing with Neutrogena acne cleansing soap, followed by the application of a benzoyl peroxide preparation of a suitable strength. If necessary, further degreasing can be achieved by cleansing with isopropyl alcohol after washing with the Neutrogena soap. PMID:2941579

  12. Physical modalities for treating acne and rosacea.

    PubMed

    Jalian, H Ray; Levin, Yakir; Wanner, Molly

    2016-06-01

    Physical modalities provide an important adjunct to medical treatment of acne and rosacea. In patients who cannot tolerate or fail medical treatments, physical modalities offer an alternative approach. For cases of acne scarring, phymatous changes of rosacea, and rosacea-associated telangiectasia, physical modalities such as laser and light treatments represent the treatment of choice. We will review the use of laser and light treatments, photodynamic therapy, and other physical modalities such as targeted therapies for the treatment of acne and rosacea. PMID:27416315

  13. Overcome Cancer Cell Drug Resistance Using Natural Products

    PubMed Central

    Wang, Pu; Yang, Hua Li; Yang, Ying Juan; Wang, Lan; Lee, Shao Chin

    2015-01-01

    Chemotherapy is one of the major treatment methods for cancer. However, failure in chemotherapy is not uncommon, mainly due to dose-limiting toxicity associated with drug resistance. Management of drug resistance is important towards successful chemotherapy. There are many reports in the Chinese literature that natural products can overcome cancer cell drug resistance, which deserve sharing with scientific and industrial communities. We summarized the reports into four categories: (1) in vitro studies using cell line models; (2) serum pharmacology; (3) in vivo studies using animal models; and (4) clinical studies. Fourteen single compounds were reported to have antidrug resistance activity for the first time. In vitro, compounds were able to overcome drug resistance at nontoxic or subtoxic concentrations, in a dose-dependent manner, by inhibiting drug transporters, cell detoxification capacity, or cell apoptosis sensitivity. Studies in vivo showed that single compounds, herbal extract, and formulas had potent antidrug resistance activities. Importantly, many single compounds, herbal extracts, and formulas have been used clinically to treat various diseases including cancer. The review provides comprehensive data on use of natural compounds to overcome cancer cell drug resistance in China, which may facilitate the therapeutic development of natural products for clinical management of cancer drug resistance. PMID:26421052

  14. Meeting the Challenges of Acne Treatment in Asian Patients: A Review of the Role of Dermocosmetics as Adjunctive Therapy.

    PubMed

    Goh, Chee Leok; Noppakun, Nopadon; Micali, Giuseppe; Azizan, Noor Zalmy; Boonchai, Waranya; Chan, Yung; Cheong, Wai Kwong; Chiu, Pin Chi; Etnawati, Kristiana; Gulmatico-Flores, Zharlah; Foong, Henry; Kubba, Raj; Paz-Lao, Purita; Lee, Yin Yin; Loo, Steven; Modi, Farida; Nguyen, Trong Hao; Pham, Thi Lan; Shih, Yi Hsien; Sitohang, Irma Bernadette; Wong, Su Ni

    2016-01-01

    Conventional acne treatment presents several challenges such as intolerable side effects and antibiotic resistance. Dermocosmetic products may be used to reduce these unwanted effects. Dermocosmetics include skin cleansers, topical sebum-controllers, skin antimicrobial/anti-inflammatory agents, moisturizers, sunscreens, and camouflage products. Appropriate use of these products may help augment the benefit of acne treatment, minimize side effects, and reduce the need for topical antibiotics. In Asia, there is currently limited scientific data on the application and recommendations for dermocosmetic use in acne vulgaris (AV). This article reviews the evidence on dermocosmetics for AV and provides practice recommendations as discussed during the 4(th) Asia-Pacific Acne Leaders' Summit held in Bangkok, Thailand, on 7 and 8 February 2015. Through a premeeting survey, a series of plenary lectures, a stepwise program of discussion sessions, and Medline article review, the Expert Panel set forth relevant recommendations on the role of dermocosmetics as adjunct for treating AV in Asian patients. PMID:27398008

  15. Meeting the Challenges of Acne Treatment in Asian Patients: A Review of the Role of Dermocosmetics as Adjunctive Therapy

    PubMed Central

    Goh, Chee Leok; Noppakun, Nopadon; Micali, Giuseppe; Azizan, Noor Zalmy; Boonchai, Waranya; Chan, Yung; Cheong, Wai Kwong; Chiu, Pin Chi; Etnawati, Kristiana; Gulmatico-Flores, Zharlah; Foong, Henry; Kubba, Raj; Paz-Lao, Purita; Lee, Yin Yin; Loo, Steven; Modi, Farida; Nguyen, Trong Hao; Pham, Thi Lan; Shih, Yi Hsien; Sitohang, Irma Bernadette; Wong, Su Ni

    2016-01-01

    Conventional acne treatment presents several challenges such as intolerable side effects and antibiotic resistance. Dermocosmetic products may be used to reduce these unwanted effects. Dermocosmetics include skin cleansers, topical sebum-controllers, skin antimicrobial/anti-inflammatory agents, moisturizers, sunscreens, and camouflage products. Appropriate use of these products may help augment the benefit of acne treatment, minimize side effects, and reduce the need for topical antibiotics. In Asia, there is currently limited scientific data on the application and recommendations for dermocosmetic use in acne vulgaris (AV). This article reviews the evidence on dermocosmetics for AV and provides practice recommendations as discussed during the 4th Asia-Pacific Acne Leaders' Summit held in Bangkok, Thailand, on 7 and 8 February 2015. Through a premeeting survey, a series of plenary lectures, a stepwise program of discussion sessions, and Medline article review, the Expert Panel set forth relevant recommendations on the role of dermocosmetics as adjunct for treating AV in Asian patients. PMID:27398008

  16. Antimicrobiol susceptibility of Propinibacterium acnes and related microbial species.

    PubMed

    Hoeffler, U; Ko, H L; Pulverer, G

    1976-09-01

    The minimal inhibitory concentrations of 32 antimicrobial agents were established for 73 strains of Propionibacterium acnes and four related species (P. granulosum, P. avidum, Corynebacterium minutissimum, and C. parvum). Most strains showed good susceptibility to those agents usually considered active against gram-positive organisms. With the exception of C. minutissimum, the strains tested revealed more or less identical susceptibility ranges. The lowest minimal inhibitory concentrations were observed with benzylpenicillin, ampicillin, cephalothin, rifampin, erythromycin, clindamycin, and minocycline. C. minutissimum was more susceptible to gentamicin, sisomicin, tobramycin, and fusidic acid but more resistant to most other drugs than were the other species examined. PMID:984781

  17. Microfluidics-assisted in vitro drug screening and carrier production

    PubMed Central

    Tsui, Jonathan H.; Lee, Woohyuk; Pun, Suzie H.; Kim, Jungkyu; Kim, Deok-Ho

    2013-01-01

    Microfluidic platforms provide several unique advantages for drug development. In the production of drug carriers, physical properties such as size and shape, and chemical properties such as drug composition and pharmacokinetic parameters, can be modified simply and effectively by tuning the flow rate and geometries. Large numbers of carriers can then be fabricated with minimal effort and with little to no batch-to-batch variation. Additionally, cell or tissue culture models in microfluidic systems can be used as in vitro drug screening tools. Compared to in vivo animal models, microfluidic drug screening platforms allow for high-throughput and reproducible screening at a significantly lower cost, and when combined with current advances in tissue engineering, are also capable of mimicking native tissues. In this review, various microfluidic platforms for drug and gene carrier fabrication are reviewed to provide guidelines for designing appropriate carriers. In vitro microfluidic drug screening platforms designed for high-throughput analysis and replication of in vivo conditions are also reviewed to highlight future directions for drug research and development. PMID:23856409

  18. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling...

  19. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling...

  20. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling...

  1. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling...

  2. Suppression of Propionibacterium acnes-Induced Dermatitis by a Traditional Japanese Medicine, Jumihaidokuto, Modifying Macrophage Functions

    PubMed Central

    Sekiguchi, Kyoji; Koseki, Junichi; Tsuchiya, Kazuaki; Matsubara, Yosuke; Iizuka, Seiichi; Imamura, Sachiko; Matsumoto, Takashi; Watanabe, Junko; Kaneko, Atsushi; Aiba, Setsuya; Yamasaki, Kenshi

    2015-01-01

    Purpose. Macrophages serve as sweepers of microbes and inflammation-derived wastes and regulators of inflammation. Some traditional Japanese medicines are reported to have adjuvant effects by modifying macrophages. Our aim was to characterize the actions of jumihaidokuto (JHT) for treatment of skin inflammations including acne vulgaris, in which Propionibacterium acnes has pathogenic roles. Methods. Dermatitis was induced in rat ears by intradermal injection of P. acnes. JHT or prednisolone (PDN) was given orally, and ear thickness and histology were evaluated. The effects of constituents and metabolites of JHT on monocytes were tested by cell-based assays using the human monocytic THP-1 cell. Results. JHT and PDN suppressed the ear thickness induced by P. acnes injection. Histological examinations revealed that JHT, but not PDN, promoted macrophage accumulation at 24 h after the injection. PDN suppressed the macrophage chemokine MCP-1 in the inflamed ears, while JHT did not affect it. The JHT constituents liquiritigenin and isoliquiritin increased expression of CD86 (type-1 macrophage marker) and CD192 (MCP-1 receptor) and enhanced phagocytosis by THP-1. Conclusions. JHT suppressed dermatitis, probably by enhancing type-1 macrophage functions, with an action different from PDN. JHT may be a beneficial drug in treatment of skin inflammation induced by P. acnes. PMID:26495013

  3. Complementary therapies for acne vulgaris

    PubMed Central

    Cao, Huijuan; Yang, Guoyan; Wang, Yuyi; Liu, Jian Ping; Smith, Caroline A; Luo, Hui; Liu, Yueming

    2015-01-01

    Background Acne is a chronic skin disease characterised by inflamed spots and blackheads on the face, neck, back, and chest. Cysts and scarring can also occur, especially in more severe disease. People with acne often turn to complementary and alternative medicine (CAM), such as herbal medicine, acupuncture, and dietary modifications, because of their concerns about the adverse effects of conventional medicines. However, evidence for CAM therapies has not been systematically assessed. Objectives To assess the effects and safety of any complementary therapies in people with acne vulgaris. Search methods We searched the following databases from inception up to 22 January 2014: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 1), MEDLINE (from 1946), Embase (from 1974), PsycINFO (from 1806), AMED (from 1985), CINAHL (from 1981), Scopus (from 1966), and a number of other databases listed in the Methods section of the review. The Cochrane CAM Field Specialised Register was searched up to May 2014. We also searched five trials registers and checked the reference lists of articles for further references to relevant trials. Selection criteria We included parallel-group randomised controlled trials (or the first phase data of randomised cross-over trials) of any kind of CAM, compared with no treatment, placebo, or other active therapies, in people with a diagnosis of acne vulgaris. Data collection and analysis Three authors collected data from each included trial and evaluated the methodological quality independently. They resolved disagreements by discussion and, as needed, arbitration by another author. Main results We included 35 studies, with a total of 3227 participants. We evaluated the majority as having unclear risk of selection, attrition, reporting, detection, and other biases. Because of the clinical heterogeneity between trials and the incomplete data reporting, we could only include four

  4. [Trade-offs in oral drug product development].

    PubMed

    Kondo, Hiromu; Sako, Kazuhiro

    2015-01-01

    Drug products are developed to meet multiple targets, thereby increasing their value. Pharmaceutical scientists encounter several trade-offs during the development of novel oral formulations. These trade-offs are generated by their desire to supply the highest possible quality products under the prevailing conditions of limited time and cost, and feasible options. When there are two incompatible factors, it is sometimes difficult to dismiss one element. This is because a quality target product profile (QTPP) is critical for each product being developed, and all elements should basically be satisfied with the criteria. Therefore, technological innovation becomes important to overcome the trade-offs. This article introduces examples of such innovations which have been successful in doing this, as well as some encountered in the oral formulation development and in the selection of proper dosage forms. Based on these examples, points to be considered in order to produce the drug product are thoroughly discussed. PMID:25747218

  5. Activity-guided purification identifies lupeol, a pentacyclic triterpene, as a therapeutic agent multiple pathogenic factors of acne.

    PubMed

    Kwon, Hyuck Hoon; Yoon, Ji Young; Park, Seon Yong; Min, Seonguk; Kim, Yong-il; Park, Ji Yong; Lee, Yun-Sang; Thiboutot, Diane M; Suh, Dae Hun

    2015-06-01

    Acne vulgaris is a nearly universal cutaneous disease characterized by multifactorial pathogenic processes. Because current acne medications have various side effects, investigating new pharmacologically active molecules is important for treating acne. As natural products generally provide various classes of relatively safe compounds with medicinal potentials, we performed activity-guided purification after a series of screenings from the extracts of five medicinal plants to explore alternative acne medications. Lupeol, a pentacyclic triterpene, from the hexane extract of Solanum melongena L. (SM) was identified after instrumental analysis. Lupeol targeted most of the major pathogenic features of acne with desired physicochemical traits. It strongly suppressed lipogenesis by modulating the IGF-1R/phosphatidylinositide 3 kinase (PI3K)/Akt/sterol response element-binding protein-1 (SREBP-1) signaling pathway in SEB-1 sebocytes, and reduced inflammation by suppressing the NF-κB pathway in SEB-1 sebocytes and HaCaT keratinocytes. Lupeol exhibited a marginal effect on cell viability and may have modulated dyskeratosis of the epidermis. Subsequently, histopathological analysis of human patients' acne tissues after applying lupeol for 4 weeks demonstrated that lupeol markedly attenuated the levels of both the number of infiltrated cells and major pathogenic proteins examined in vitro around comedones or sebaceous glands, providing solid evidence for suggested therapeutic mechanisms. These results demonstrate the clinical feasibility of applying lupeol for the treatment of acne. PMID:25647437

  6. Topical taurine bromamine, a new candidate in the treatment of moderate inflammatory acne vulgaris: a pilot study.

    PubMed

    Marcinkiewicz, Janusz; Wojas-Pelc, Anna; Walczewska, Maria; Lipko-Godlewska, Sylwia; Jachowicz, Renata; Maciejewska, Aldona; Białecka, Anna; Kasprowicz, Andrzej

    2008-01-01

    Taurine bromamine (TauBr), the product of taurine and hypobromous acid (HOBr), exerts anti-inflammatory and antibacterial properties. Recently we have shown that Propionibacterium acnes, a potential pathogenic agent of acne, is extremely sensitive to TauBr. As topical antibiotics are associated with the emergence of resistant bacteria, TauBr seems to be a good candidate for topical therapy for acne vulgaris. In our double blind investigation, the efficacy and safety of 3.5 mM TauBr cream was evaluated. 1% Clindamycin gel (Clindacin T), one of the most common topical agents in the treatment of acne vulgaris, was used as a control. Forty patients with mild to moderate inflammatory facial acne vulgaris were randomly treated with either TauBr or clindamycin for 6 weeks, twice-a-day. More than 80% of the patients markedly improved with both treatments, without any adverse effects observed. Both TauBr and clindamycin produced a significant reduction in inflammatory skin lesion counts (papules/ pustules). After 6 weeks, comparable reductions of acne lesions, 65% and 68%, were observed in the TauBr and clindamycin groups, respectively. In conclusion, these data support our concept that TauBr can be used as a topical agent in the treatment of acne vulgaris, especially in patients who have already developed antibiotic resistance. PMID:18573718

  7. Making the case for early treatment of acne.

    PubMed

    Zaenglein, Andrea L

    2010-01-01

    Early acne can be defined as the occurrence of acne at its onset, primarily in preteens, or as acne at its earliest severity (ie, mild to moderate). Although the majority of patients with acne are treated by dermatologists, most, particularly mild to moderate cases, could be successfully managed by primary care physicians. Therefore, it is important for physicians to understand the benefits of treating all types of acne, not just the most severe. Awareness of the emotional impact of acne, particularly in adolescence, as well as recognition of possible scarring are important considerations. To achieve optimal results, physicians should be familiar with classification and severity grading of acne. Also, in-depth knowledge of available acne medications will streamline and optimize treatment regimens. Recognizing, treating, and monitoring the progress of early acne may lead to quicker, better clinical outcomes and improved quality of life. PMID:19738184

  8. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products marketed as over-the-counter (OTC) daytime sedatives. 310.519 Section 310.519 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.519 Drug products...

  9. 21 CFR 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products marketed as over-the-counter (OTC) daytime sedatives. 310.519 Section 310.519 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.519 Drug products...

  10. Recreational drug discovery: natural products as lead structures for the synthesis of smart drugs.

    PubMed

    Appendino, Giovanni; Minassi, Alberto; Taglialatela-Scafati, Orazio

    2014-07-01

    Covering: up to December 2013. Over the past decade, there has been a growing transition in recreational drugs from natural materials (marijuana, hashish, opium), natural products (morphine, cocaine), or their simple derivatives (heroin), to synthetic agents more potent than their natural prototypes, which are sometimes less harmful in the short term, or that combine properties from different classes of recreational prototypes. These agents have been named smart drugs, and have become popular both for personal consumption and for collective intoxication at rave parties. The reasons for this transition are varied, but are mainly regulatory and commercial. New analogues of known illegal intoxicants are invisible to most forensic detection techniques, while the alleged natural status and the lack of avert acute toxicity make them appealing to a wide range of users. On the other hand, the advent of the internet has made possible the quick dispersal of information among users and the on-line purchase of these agents and/or the precursors for their synthesis. Unlike their natural products chemotypes (ephedrine, mescaline, cathinone, psilocybin, THC), most new drugs of abuse are largely unfamiliar to the organic chemistry community as well as to health care providers. To raise awareness of the growing plague of smart drugs we have surveyed, in a medicinal chemistry fashion, their development from natural products leads, their current methods of production, and the role that clandestine home laboratories and underground chemists have played in the surge of popularity of these drugs. PMID:24823967

  11. Should dermatologists prescribe hormonal contraceptives for acne?

    PubMed

    Harper, Julie C

    2009-01-01

    ABSTRACT One of the primary factors contributing to the development of acne vulgaris is excess sebum. Sebaceous glands and sebum excretion are regulated, at least in part, by androgen hormones. Acne treatments that block this androgen effect include spironolactone and combination oral contraceptives (COC). Three COC are now FDA approved to treat moderate acne. Dermatologists must become experts at prescribing these hormonal contraceptives. Likewise, it is vital to be aware of contraindications to hormonal contraceptive therapy. Proper patient selection relies on an appropriate medical history and an assessment of blood pressure. A pelvic exam and/or Papanicolaou smear are not required prior to initiating therapy with a COC. It is important to counsel patients about potential adverse effects of COC pills and to establish appropriate expectations concerning acne improvement. PMID:19845722

  12. What's new in acne and rosacea?

    PubMed

    Keri, Jonette

    2016-06-01

    Acne and rosacea are common conditions seen every day by dermatologists. This review will discuss the most recent therapeutic options for patients with these conditions. Specifically, for acne, there will be a discussion of the use of isotretinoin at higher cumulative doses as well as a new formulation of isotretinoin, isotretinoin-lidose. Adult women with acne represent a growing population of patients who present for treatment of acne; the use of hormonal therapies as well as topical dapsone gel will be reviewed for these patients. For rosacea patients, the new topical agents - brimonidine gel and ivermectin cream - will be reviewed, with a discussion on possible rebound phenomenon from brimonidine. Finally, future treatments in the pipeline will be discussed. PMID:27416316

  13. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Bromfenac sodium: All drug products containing bromfenac sodium. Butamben: All parenteral drug products... more of diethylstilbestrol per unit dose. Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate. Dipyrone: All drug products containing dipyrone. Encainide hydrochloride: All...

  14. Light-based therapies in acne treatment

    PubMed Central

    Pei, Susan; Inamadar, Arun C.; Adya, Keshavmurthy A.; Tsoukas, Maria M.

    2015-01-01

    The use of light and laser in the treatment of acne is increasing as these modalities are safe, effective, and associated with no or minimal complications when used appropriately. These light and laser sources are also being used in combination with pharmacological and/or physical measures to synergize their effects and optimize the therapeutic outcome. This review focuses on optical devices used in treating acne and serves to delineate the current application of various methods, including their utility and efficacy. PMID:26009707

  15. 21 CFR 344.52 - Labeling of ear drying aid drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of ear drying aid drug products. 344.52... Labeling of ear drying aid drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.”...

  16. 21 CFR 344.52 - Labeling of ear drying aid drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of ear drying aid drug products. 344.52... Labeling of ear drying aid drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.”...

  17. 21 CFR 344.52 - Labeling of ear drying aid drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of ear drying aid drug products. 344.52... Labeling of ear drying aid drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.”...

  18. 21 CFR 344.52 - Labeling of ear drying aid drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of ear drying aid drug products. 344.52... Labeling of ear drying aid drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.”...

  19. 21 CFR 344.52 - Labeling of ear drying aid drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of ear drying aid drug products. 344.52... Labeling of ear drying aid drug products. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.”...

  20. Utility and importance of animal data in drug product labels.

    PubMed

    Baldrick, Paul

    2014-08-01

    Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. PMID:24928564

  1. [Current situation and issues for analyzing illegal drug products].

    PubMed

    Hasegawa, Takashi; Takahashi, Kazunaga; Saijo, Masaaki; Fukiwake, Tomohide; Motoki, Yuji

    2013-01-01

    Thirty-two psychotropic substances (31 compounds and one plant) have been controlled as designated substances (Shitei-yakubutsu) in Japan by the Pharmaceutical Affairs Law since April 2007. Although the trafficking of these drugs has decreased because of this regulation, new designer drugs (synthetic cannabinoids and cathinones) have appeared, one after the other. As of October 2011, 40 compounds had been newly added to this category. Analytical methods have become more complicated due to this increase in the number of designated substances. Moreover, many reference substances for such designated substances and other new designer drugs are not commercially available. For the reasons stated above, a lot of time and effort is required to analyze the illegal drug products available on the market. PMID:23292013

  2. Acne

    MedlinePlus

    ... suggest you also try an over-the-counter lotion or cream. These medicines may make your skin ... work, your doctor may prescribe a cream or lotion with benzoyl peroxide, resorcinol, salicylic acid, or sulfur. ...

  3. Acne

    MedlinePlus

    ... are available in many forms, such as gels, lotions, creams, soaps, or pads. In some people, OTC ... topical medicines, prescription topical medicines come as creams, lotions, solutions, gels, or pads. Your doctor will consider ...

  4. Microneedling Therapy for Atrophic Acne Scars

    PubMed Central

    Barakat, Manal; Awad, Sherif; Medhat, Walid; El-Fakahany, Hasan; Farag, Hanna

    2015-01-01

    Objective: Treatment of acne scarring is always a challenge. Microneedling therapy or percutaneous collagen induction is a new addition to the treatment modalities for such scars and has been reported to be simple and effective in atrophic acne scar treatment. The aim of this study is to evaluate the clinical effect and objectively quantify the histological changes of acne scarring in response to skin microneedling. Design: A prospective clinical study. Participants: Ten patients with different types of atrophic acne scars were subjected to three months of skin microneedling treatment (six sessions at two-week intervals). Measurements: Patients were photographed, and skin biopsies were obtained at baseline as well as one and three months from the start of treatment. Histometry for epidermal thickness and quantitative evaluation of total elastin; newly synthesized tropoelastin; collagen types I, III, and VII; and newly synthesized collagen were performed for all biopsies. Results: Compared to the baseline, patients’ evaluations revealed noticeable clinical improvement in atrophic post-acne scars in response to skin microneedling. There was a statistically significant increase (p<0.05) in the mean of collagen types I, III, and VII and newly synthesized collagen, while total elastin was significantly decreased (p<0.05) after the end of treatment. Conclusions: Multiple minimally invasive sessions of skin microneedling are an effective treatment for post-acne atrophic scars as it stimulates the repair processes with the advantage of being a relatively risk-free, in-office procedure with minimal patient recovery time. PMID:26203319

  5. Effective Treatments of Atrophic Acne Scars

    PubMed Central

    Zhou, Bingrong

    2015-01-01

    Atrophic scarring is often an unfortunate and permanent complication of acne vulgaris. It has high prevalence, significant impact on quality of life, and therapeutic challenge for dermatologists. The treatment of atrophic acne scars varies depending on the types of acne scars and the limitations of the treatment modalities in their ability to improve scars. Therefore, many options are available for the treatment of acne scarring, including chemical peeling, dermabrasion, laser treatment, punch techniques, fat transplantation, other tissue augmenting agents, needling, subcision, and combined therapy. Various modalities have been used to treat scars, but limited efficacy and problematic side effects have restricted their application. In order to optimally treat a patient’s scar, we need to consider which treatment offers the most satisfactory result. There are also promising procedures in the future, such as stem cell therapy. In this article, the authors review the different treatment options of atrophic acne scars. This may be useful for selecting the best therapeutic strategy, whether it be single or combined therapy, in the treatment of atrophic acne scars while reducing or avoiding the side effects and complications. PMID:26029333

  6. Imaging inflammatory acne: lesion detection and tracking

    NASA Astrophysics Data System (ADS)

    Cula, Gabriela O.; Bargo, Paulo R.; Kollias, Nikiforos

    2010-02-01

    It is known that effectiveness of acne treatment increases when the lesions are detected earlier, before they could progress into mature wound-like lesions, which lead to scarring and discoloration. However, little is known about the evolution of acne from early signs until after the lesion heals. In this work we computationally characterize the evolution of inflammatory acne lesions, based on analyzing cross-polarized images that document acne-prone facial skin over time. Taking skin images over time, and being able to follow skin features in these images present serious challenges, due to change in the appearance of skin, difficulty in repositioning the subject, involuntary movement such as breathing. A computational technique for automatic detection of lesions by separating the background normal skin from the acne lesions, based on fitting Gaussian distributions to the intensity histograms, is presented. In order to track and quantify the evolution of lesions, in terms of the degree of progress or regress, we designed a study to capture facial skin images from an acne-prone young individual, followed over the course of 3 different time points. Based on the behavior of the lesions between two consecutive time points, the automatically detected lesions are classified in four categories: new lesions, resolved lesions (i.e. lesions that disappear completely), lesions that are progressing, and lesions that are regressing (i.e. lesions in the process of healing). The classification our methods achieve correlates well with visual inspection of a trained human grader.

  7. Marine natural products: a new wave of drugs?

    PubMed Central

    Montaser, Rana; Luesch, Hendrik

    2011-01-01

    The largely unexplored marine world that presumably harbors the most biodiversity may be the vastest resource to discover novel ‘validated’ structures with novel modes of action that cover biologically relevant chemical space. Several challenges, including the supply problem and target identification, need to be met for successful drug development of these often complex molecules; however, approaches are available to overcome the hurdles. Advances in technologies such as sampling strategies, nanoscale NMR for structure determination, total chemical synthesis, fermentation and biotechnology are all crucial to the success of marine natural products as drug leads. We illustrate the high degree of innovation in the field of marine natural products, which in our view will lead to a new wave of drugs that flow into the market and pharmacies in the future. PMID:21882941

  8. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... Federal Register of April 13, 2012 (77 FR 22327), FDA published the notice of availability for a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry on New Animal Drugs and New Animal... entitled ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated...

  9. 75 FR 55676 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol; Lincomycin.... ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

  10. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study

    PubMed Central

    Mirošević Skvrce, Nikica; Macolić Šarinić, Viola; Mucalo, Iva; Krnić, Darko; Božina, Nada; Tomić, Siniša

    2011-01-01

    Aim To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence. Methods In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. Results HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drug-drug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n = 4) was significantly higher (P < 0.001) than among the remaining reports (580 out of 1982; n = 2, respectively). Actual drug-drug interactions most frequently involved nervous system agents (34.0%), and interactions caused by antiplatelet, anticoagulant, and non-steroidal anti-inflammatory drugs were in most cases serious. In only 12 out of 94 reports, actual drug-drug interactions were recognized by the reporter. Conclusion The study confirmed that the Spontaneous Reporting Database was a valuable resource for detecting actual drug-drug interactions. Also, it identified drugs leading to serious adverse drug reactions and deaths, thus indicating the areas which should be in the focus of health care education. PMID:21990078

  11. Propionibacterium acnes Recovered from Atherosclerotic Human Carotid Arteries Undergoes Biofilm Dispersion and Releases Lipolytic and Proteolytic Enzymes in Response to Norepinephrine Challenge In Vitro.

    PubMed

    Lanter, Bernard B; Davies, David G

    2015-10-01

    In the present study, human atherosclerotic carotid arteries were examined following endarterectomy for the presence of the Gram-positive bacterium Propionibacterium acnes and its potential association with biofilm structures within the arterial wall. The P. acnes 16S rRNA gene was detectable in 4 of 15 carotid artery samples, and viable P. acnes was one among 10 different bacterial species recoverable in culture. Fluorescence in situ hybridization analysis of 5 additional atherosclerotic carotid arteries demonstrated biofilm bacteria within all samples, with P. acnes detectable in 4 samples. We also demonstrated that laboratory-grown cultures of P. acnes biofilms were susceptible to induction of a biofilm dispersion response when challenged with physiologically relevant levels of norepinephrine in the presence of iron-bound transferrin or with free iron. The production and release of lipolytic and proteolytic extracellular enzymes by P. acnes were shown to increase in iron-induced dispersed biofilms, and these dispersion-induced P. acnes VP1 biofilms showed increased expression of mRNAs for the triacylglycerol lipases PPA2105 and PPA1796 and the hyaluronate lyase PPA380 compared to that in untreated biofilms. These results demonstrate that P. acnes can infect the carotid arteries of humans with atherosclerosis as a component of multispecies biofilms and that dispersion is inducible for this organism, at least in vitro, with physiologically relevant levels of norepinephrine resulting in the production and release of degradative enzymes. PMID:26216428

  12. Propionibacterium acnes Recovered from Atherosclerotic Human Carotid Arteries Undergoes Biofilm Dispersion and Releases Lipolytic and Proteolytic Enzymes in Response to Norepinephrine Challenge In Vitro

    PubMed Central

    Lanter, Bernard B.

    2015-01-01

    In the present study, human atherosclerotic carotid arteries were examined following endarterectomy for the presence of the Gram-positive bacterium Propionibacterium acnes and its potential association with biofilm structures within the arterial wall. The P. acnes 16S rRNA gene was detectable in 4 of 15 carotid artery samples, and viable P. acnes was one among 10 different bacterial species recoverable in culture. Fluorescence in situ hybridization analysis of 5 additional atherosclerotic carotid arteries demonstrated biofilm bacteria within all samples, with P. acnes detectable in 4 samples. We also demonstrated that laboratory-grown cultures of P. acnes biofilms were susceptible to induction of a biofilm dispersion response when challenged with physiologically relevant levels of norepinephrine in the presence of iron-bound transferrin or with free iron. The production and release of lipolytic and proteolytic extracellular enzymes by P. acnes were shown to increase in iron-induced dispersed biofilms, and these dispersion-induced P. acnes VP1 biofilms showed increased expression of mRNAs for the triacylglycerol lipases PPA2105 and PPA1796 and the hyaluronate lyase PPA380 compared to that in untreated biofilms. These results demonstrate that P. acnes can infect the carotid arteries of humans with atherosclerosis as a component of multispecies biofilms and that dispersion is inducible for this organism, at least in vitro, with physiologically relevant levels of norepinephrine resulting in the production and release of degradative enzymes. PMID:26216428

  13. 21 CFR 355.55 - Principal display panel of all fluoride rinse drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Principal display panel of all fluoride rinse drug products. 355.55 Section 355.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 355.55 Principal display panel of all fluoride rinse drug products. In addition to the statement...

  14. 21 CFR 355.55 - Principal display panel of all fluoride rinse drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Principal display panel of all fluoride rinse drug products. 355.55 Section 355.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 355.55 Principal display panel of all fluoride rinse drug products. In addition to the statement...

  15. 21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice...

  16. 21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice...

  17. 21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice...

  18. 21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice...

  19. 21 CFR 355.55 - Principal display panel of all fluoride rinse drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Principal display panel of all fluoride rinse drug products. 355.55 Section 355.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 355.55 Principal display panel of all fluoride rinse drug products. In addition to the statement...

  20. 21 CFR 355.55 - Principal display panel of all fluoride rinse drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Principal display panel of all fluoride rinse drug products. 355.55 Section 355.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 355.55 Principal display panel of all fluoride rinse drug products. In addition to the statement...

  1. 21 CFR 355.55 - Principal display panel of all fluoride rinse drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Principal display panel of all fluoride rinse drug products. 355.55 Section 355.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 355.55 Principal display panel of all fluoride rinse drug products. In addition to the statement...

  2. 21 CFR 352.50 - Principal display panel of all sunscreen drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Principal display panel of all sunscreen drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 352.50 Principal display panel of all sunscreen drug products. In addition to the statement...

  3. 21 CFR 352.50 - Principal display panel of all sunscreen drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Principal display panel of all sunscreen drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 352.50 Principal display panel of all sunscreen drug products. In addition to the statement...

  4. 21 CFR 352.50 - Principal display panel of all sunscreen drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Principal display panel of all sunscreen drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 352.50 Principal display panel of all sunscreen drug products. In addition to the statement...

  5. 21 CFR 352.50 - Principal display panel of all sunscreen drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Principal display panel of all sunscreen drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 352.50 Principal display panel of all sunscreen drug products. In addition to the statement...

  6. 21 CFR 352.50 - Principal display panel of all sunscreen drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Principal display panel of all sunscreen drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 352.50 Principal display panel of all sunscreen drug products. In addition to the statement...

  7. 21 CFR 355.70 - Testing procedures for fluoride dentifrice drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Testing procedures for fluoride dentifrice drug... SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Testing Procedures § 355.70 Testing procedures for fluoride dentifrice drug products. (a) A fluoride dentifrice...

  8. Solid Lipid Nanoparticles Loaded with Retinoic Acid and Lauric Acid as an Alternative for Topical Treatment of Acne Vulgaris.

    PubMed

    Silva, Elton Luiz; Carneiro, Guilherme; De Araújo, Lidiane Advíncula; Trindade, Mariana de Jesus Vaz; Yoshida, Maria Irene; Oréfice, Rodrigo Lambert; Farias, Luis de Macêdo; De Carvalho, Maria Auxiliadora Roque; Dos Santos, Simone Gonçalves; Goulart, Gisele Assis Castro; Alves, Ricardo José; Ferreira, Lucas Antônio Miranda

    2015-01-01

    Topical therapy is the first choice for the treatment of mild to moderate acne and all-trans retinoic acid is one of the most used drugs. The combination of retinoids and antimicrobials is an innovative approach for acne therapy. Recently, lauric acid, a saturated fatty acid, has shown strong antimicrobial activity against Propionibacterium acnes. However, topical application of retinoic acid is followed by high incidence of side-effects, including erythema and irritation. Solid lipid nanoparticles represent an alternative to overcome these side-effects. This work aims to develop solid lipid nanoparticles loaded with retinoic acid and lauric acid and evaluate their antibacterial activity. The influence of lipophilic stearylamine on the characteristics of solid lipid nanoparticles was investigated. Solid lipid nanoparticles were characterized for size, zeta potential, encapsulation efficiency, differential scanning calorimetry and X-ray diffraction. The in vitro inhibitory activity of retinoic acid-lauric acid-loaded solid lipid nanoparticles was evaluated against Propionibacterium acnes, Staphylococcus aureus and Staphylococcus epidermidis. High encapsulation efficiency was obtained at initial time (94 ± 7% and 100 ± 4% for retinoic acid and lauric acid, respectively) and it was demonstrated that lauric acid-loaded-solid lipid nanoparticles provided the incorporation of retinoic acid. However, the presence of stearylamine is necessary to ensure stability of encapsulation. Moreover, retinoic acid-lauric acid-loaded solid lipid nanoparticles showed growth inhibitory activity against Staphylococcus epidermidis, Propionibacterium acnes and Staphylococcus aureus, representing an interesting alternative for the topical therapy of acne vulgaris. PMID:26328443

  9. Drug information service for drug product procurement in the Veterans Affairs health-care system: preliminary experience.

    PubMed

    Haynes, L M; Patterson, A A; Wade, S U

    1992-03-01

    The preliminary experience of the drug information service of the Department of Veterans Affairs (VA) central office is described. The drug information service assists the drug and pharmaceutical product management section of the pharmacy service for the VA central office. The purpose of the drug information service is to promote efficacious drug therapy while meeting cost containment goals for pharmaceutical products. The pharmacist coordinator of this service has experience in both patient care and drug information service. The drug information service is involved in the following activities: (1) making recommendations for contract bidding on therapeutically equivalent products, (2) identifying prescription duplication within the system, (3) reporting product defects, (4) planning drug procurement in unique situations, such as during war, (5) developing gender-specific therapy, (6) evaluating the appropriateness of brand-name-only purchasing of certain products, (7) evaluating new drug products, (8) compiling national drug-use data, and (9) projecting drug price increases. The VA drug information service has diverse responsibilities meant to optimize drug therapy and reduce pharmacy costs in the VA health-care system. PMID:1598933

  10. Randomised controlled trial of topical kanuka honey for the treatment of acne

    PubMed Central

    Semprini, Alex; Corin, Andrew; Sheahan, Davitt; Tofield, Christopher; Helm, Colin; Montgomery, Barney; Fingleton, James; Weatherall, Mark; Beasley, Richard

    2016-01-01

    Objective To investigate the efficacy of Honevo, a topical 90% medical-grade kanuka honey, and 10% glycerine (honey product) as a treatment for facial acne. Design Randomised controlled trial with single blind assessment of primary outcome variable. Setting Outpatient primary care from 3 New Zealand localities. Participants Of 136 participants aged between 16 and 40 years with a diagnosis of acne and baseline Investigator's Global Assessment (IGA) for acne score of ≥2.68, participants were randomised to each treatment arm. Interventions All participants applied Protex, a triclocarban-based antibacterial soap twice daily for 12 weeks. Participants randomised to the honey product treatment arm applied this directly after washing off the antibacterial soap, twice daily for 12 weeks. Outcome measures The primary outcome was ≥2 point decrease in IGA score from baseline at 12 weeks. Secondary outcomes included mean lesion counts and changes in subject-rated acne improvement and severity at weeks 4 and 12, and withdrawals for worsening acne. Results 4/53 (7.6%) participants in the honey product group and 1/53 (1.9%) of participants in the control group had a ≥ 2 improvement in IGA score at week 12, compared with baseline, OR (95% CI) for improvement 4.2 (0.5 to 39.3), p=0.17. There were 15 and 14 participants who withdrew from the honey product group and control group, respectively. Conclusions This randomised controlled trial did not find evidence that addition of medical-grade kanuka honey in combination with 10% glycerine to standard antibacterial soap treatment is more effective than the use of antibacterial soap alone in the treatment of acne. Trial registration number ACTRN12614000003673; Results. PMID:26832428

  11. 21 CFR 314.162 - Removal of a drug product from the list.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Removal of a drug product from the list. 314.162 Section 314.162 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on...

  12. Comparison of clinical efficacies of sodium ascorbyl phosphate, retinol and their combination in acne treatment.

    PubMed

    Ruamrak, C; Lourith, N; Natakankitkul, S

    2009-02-01

    Acne vulgaris impairs the appearance of an individual and causes psychological irritation. Inflammatory acne lesion is caused by multifactor incorporates in each step of acne pathogenesis. In an attempt to archive inflammatory lesion treatment with the promise of prevention of acne vulgaris, randomized and double-blind studies on the comparison of the efficacies of topical formulations containing 5% sodium ascorbyl phosphate (SAP) and 0.2% retinol, separately as well as in combination application, were conducted. The resulting data showed that SAP reduced the inflammatory lesion by 20.14% and 48.82% within 4 and 8 weeks respectively. Application of the formulation containing retinol slightly improved the treatment efficacy as the lesion reduced by 21.79% and 49.50% after 4 and 8 weeks respectively. The combination treatment significantly reduced the inflammatory lesion by 29.28% after 4 weeks and 63.10% after 8 weeks of application. The most effective treatment was by using the combination of 5% SAP and 0.2% retinol, which incorporated the synergistic effects on lipid peroxidation and sebaceous gland function in addition to the enhancement of SAP permeability by the desquamation of stratum corneum influenced by retinol, keratin plug removal and anti-inflammatory effect of retinol. This study promises for the development of cosmetic products to overcome aesthetic and psychological problems caused by acne vulgaris. PMID:19134126

  13. Inhibition of Propionibacterium acnes-induced mediators of inflammation by Indian herbs.

    PubMed

    Jain, A; Basal, E

    2003-01-01

    Propionibacterium acnes, an anaerobic pathogen, plays an important role in the pathogenesis of acne by inducing certain inflammatory mediators. These mediators include reactive oxygen species (ROS) and pro-inflammatory cytokines. In the present study, ROS, interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-alpha) were used as the major criteria for the evaluation of anti-inflammatory activity. To prove the anti-inflammatory effects of herbs, polymorphonuclear leukocytes (PMNL) and monocytes were treated with culture supernatant of P. acnes in the presence or absence of herbs. It was found that Rubia cordifolia, Curcuma longa, Hemidesmus indicus, and Azadirachta indica caused a statistically significant suppression of ROS from PMNL. Sphaeranthus indicus caused a smaller, still significant suppression of ROS. Aloe vera had no effect on ROS production. In the case of proinflammatory cytokine-induced monocytes, maximum suppression was shown by Azadirachta indica and Sphaeranthus indicus, followed by Hemidesmus indicus, Rubia cordifolia, and Curcuma longa. Aloe vera showed insignificant inhibitory activity. Thus, these herbs shows anti-inflammatory activity by suppressing the capacity of P. acnes-induced ROS and pro-inflammatory cytokines, the two important inflammatory mediators in acne pathogenesis. PMID:12622461

  14. Correlation between the Severity and Type of Acne Lesions with Serum Zinc Levels in Patients with Acne Vulgaris

    PubMed Central

    Rostami Mogaddam, Majid; Safavi Ardabili, Nastaran; Soflaee, Maedeh

    2014-01-01

    Acne vulgaris is the most common cutaneous disorder affecting adolescents and young adults. Some studies have reported an association between serum zinc levels and acne vulgaris. We aimed to evaluate the serum zinc level in patients with acne vulgaris and compare it with healthy controls. One hundred patients with acne vulgaris and 100 healthy controls were referred to our clinic. Acne severity was classified according to Global Acne Grading System (GAGS). Atomic absorption spectrophotometry was used to measure serum zinc levels. Mean serum level of zinc in acne patients and controls was 81.31 ± 17.63 μg/dl and 82.63 ± 17.49 μg/dl, respectively. Although the mean serum zinc level was lower in acne group, it was not statistically significant (P = 0.598). There was a correlation between serum zinc levels with severity and type of acne lesions. The results of our study suggest that zinc levels may be related to the severity and type of acne lesions in patients with acne vulgaris. Relative decrease of serum zinc level in acne patients suggests a role for zinc in the pathogenesis of acne vulgaris. PMID:25157359

  15. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Magnesium sulfate heptahydrate; label...

  16. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Magnesium sulfate heptahydrate; label...

  17. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Magnesium sulfate heptahydrate; label...

  18. 21 CFR 310.518 - Drug products containing iron or iron salts.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Drug products containing iron or iron salts. 310... Drug products containing iron or iron salts. Drug products containing elemental iron or iron salts as...) that contains iron or iron salts for use as an iron source shall bear the following statement:...

  19. 21 CFR 310.518 - Drug products containing iron or iron salts.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Drug products containing iron or iron salts. 310... Drug products containing iron or iron salts. Drug products containing elemental iron or iron salts as...) that contains iron or iron salts for use as an iron source shall bear the following statement:...

  20. 21 CFR 310.518 - Drug products containing iron or iron salts.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Drug products containing iron or iron salts. 310... Drug products containing iron or iron salts. Drug products containing elemental iron or iron salts as...) that contains iron or iron salts for use as an iron source shall bear the following statement:...

  1. 21 CFR 310.518 - Drug products containing iron or iron salts.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Drug products containing iron or iron salts. 310... Drug products containing iron or iron salts. Drug products containing elemental iron or iron salts as...) that contains iron or iron salts for use as an iron source shall bear the following statement:...

  2. 21 CFR 310.518 - Drug products containing iron or iron salts.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products containing iron or iron salts. 310... Drug products containing iron or iron salts. Drug products containing elemental iron or iron salts as...) that contains iron or iron salts for use as an iron source shall bear the following statement:...

  3. 77 FR 47397 - Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-08

    ... HUMAN SERVICES Food and Drug Administration Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the Food and Drug Administration's Pediatric Subcommittee of the Oncologic... nominations. SUMMARY: The Food and Drug Administration's (FDA) Office of Hematology and Oncology...

  4. Consequences of psychological distress in adolescents with acne.

    PubMed

    Misery, Laurent

    2011-02-01

    Acne may cause psychological distress that is associated with many psychiatric disorders. In this issue, Halvorsen et al. report suicidal ideation, mental health problems, and affective isolation to be relatively frequent in adolescents with acne. This report suggests that adverse events that have been attributed to therapies for acne, including suicidal ideation and depression, may reflect the burden of substantial acne rather than the effect of medications. PMID:21228811

  5. Liposomal Drug Products: A Quality by Design Approach

    NASA Astrophysics Data System (ADS)

    Xu, Xiaoming

    Quality by Design (QbD) principles has been applied to the development of two liposomal formulations, containing a hydrophilic small molecule therapeutic (Tenofovir) and a protein therapeutic (superoxide dismutase). The goal of the research is to provide critical information on 1) how to reduce the preparation variability in liposome formulations, and 2) how to increase drug encapsulation inside liposomes to reduce manufacturing cost. Most notably, an improved liposome preparation method was developed which increased the encapsulation efficiency of hydrophilic molecules. In particular, this method allows for very high encapsulation efficiency. For example, encapsulation efficiencies of up to 50% have been achieved, whereas previously only 20% or less have been reported. Another significant outcome from this research is a first principle mathematical model to predict the encapsulation efficiency of hydrophilic drugs in unilamellar liposomes. This mathematical model will be useful in: formulation development to rapidly achieve optimized formulations; comparison of drug encapsulation efficiencies of liposomes prepared using different methods; and assisting in the development of suitable process analytical technologies to achieve real-time monitoring and control of drug encapsulation during manufacturing. A novel two-stage reverse dialysis in vitro release testing method has also been developed for passively targeted liposomes, which uses the first stage to mimic the circulation of liposomes in the body and the second stage to imitate the drug release process at the target. The developed in vitro release testing method can be used to distinguish formulations with varied compositions for quality control testing purposes. This developed method may pave the way to the development of more biorelevant quality control testing methods for liposomal drug products in the future. The QbD case studies performed in this research are examples of how this approach can be used to

  6. Photodynamic-induced inactivation of Propionibacterium acnes

    NASA Astrophysics Data System (ADS)

    Koenig, Karsten; Teschke, M.; Eick, Stephen G.; Pfister, W.; Meyer, Herbert; Halbhuber, Karl-Juergen

    1998-05-01

    We report on photodynamically induced inactivation of the skin bacterium Propionibacterium acnes (P. acnes) using endogenous as well as exogenous photosensitizers and red light sources. P. acnes is involved in the pathogenesis of the skin disease acne vulgaris. The skin bacterium is able to synthesize the metal-free fluorescent porphyrins protoporphyrin IX (PP) and coproporphyrin (CP) as shown by in situ spectrally-resolved detection of natural autofluorescence of human skin and bacteria colonies. These naturally occurring intracellular porphyrins act as efficient endogenous photosensitizers. Inactivation of P. acnes suspensions was achieved by irradiation with He-Ne laser light in the red spectral region (632.8 nm). We monitored the photodynamically-induced death of single bacteria using a fluorescent viability kit in combination with confocal laser scanning microscopy. In addition, the photo-induced inactivation was calculated by CFU (colony forming units) determination. We found 633 nm-induced inactivation (60 mW, 0.12 cm2 exposure area, 1 hour irradiation) of 72% in the case of non-incubated bacteria based on the destructive effect of singlet oxygen produced by red light excited endogenous porphyrins and subsequent energy transfer to molecular oxygen. In order to achieve a nearly complete inactivation within one exposure procedure, the exogenous photosensitizer Methylene Blue (Mb) was added. Far red exposure of Mb-labeled bacteria using a krypton ion laser at 647 nm and 676 nm resulted in 99% inactivation.

  7. A study on the characterization of Propionibacterium acnes isolated from ocular clinical specimens

    PubMed Central

    Sowmiya, Murali; Malathi, Jambulingam; Swarnali, Sen; Priya, Jeyavel Padma; Therese, Kulandai Lily; Madhavan, Hajib N.

    2015-01-01

    Background & objectives: There are only a few reports available on characterization of Propionibacterium acnes isolated from various ocular clinical specimens. We undertook this study to evaluate the role of P. acnes in ocular infections and biofilm production, and also do the phylogenetic analysis of the bacilli. Methods: One hundred isolates of P. acnes collected prospectively from ocular clinical specimens at a tertiary care eye hospital between January 2010 and December 2011, were studied for their association with various ocular disease conditions. The isolates were also subjected to genotyping and phylogenetic analysis, and were also tested for their ability to produce biofilms. Results: Among preoperative conjunctival swabs, P. acnes was a probably significant pathogen in one case; a possibly significant pathogen in two cases. In other clinical conditions, 13 per cent isolates were probably significant pathogens and 38 per cent as possibly significant pathogens. The analysis of 16S rRNA gene revealed four different phylogenies whereas analysis of recA gene showed two phylogenies confirming that recA gene was more reliable than 16S rRNA with less sequence variation. Results of polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) had 100 per cent concordance with phylogenetic results. No association was seen between P. acnes subtypes and biofilm production. Interpretation & conclusions: RecA gene phylogenetic studies revealed two different phylogenies. RFLP technique was found to be cost-effective with high sensitivity and specificity in phylogenetic analysis. No association between P. acnes subtypes and pathogenetic ability was observed. Biofilm producing isolates showed increased antibiotic resistance compared with non-biofilm producing isolates. PMID:26609036

  8. Fraxelated radiofrequency device for acne scars

    NASA Astrophysics Data System (ADS)

    Rao, Babar K.; Khokher, Sairah

    2012-09-01

    Acne scars can be improved with various treatments such as topical creams, chemical peels, dermal fillers, microdermabrasion, laser, and radiofrequency devices. Some of these treatments especially lasers and deep chemical peels can have significant side effects such as post inflammatory hyperpigmentation in darker skin types. Fraxelated RF Laser devices have been reported to have lower incidence of side effects in all skin phototypes. Nine patients between ages 18 and 35 of various skin phototypes were selected from a private practice and treated with a RF fraxelated device (E-matrix) for acne scars. Outcomes were measured by physician observation, subjective feedback received by patients, and comparison of before and after photographs. In this small group of patients with various skin phototypes, fraxelated radiofrequency device improved acne scars with minimal side effects and downtime.

  9. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of nighttime sleep-aid drug products. 338.50 Section 338.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime...

  10. 21 CFR 347.50 - Labeling of skin protectant drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of skin protectant drug products. 347.50 Section 347.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347.50 Labeling of skin protectant...

  11. Status report from the American Acne & Rosacea Society on medical management of acne in adult women, part 2: topical therapies.

    PubMed

    Del Rosso, James Q; Harper, Julie C; Graber, Emmy M; Thiboutot, Diane; Silverberg, Nanette B; Eichenfield, Lawrence F

    2015-11-01

    In part 1 of this 3-part series, an overview of the epidemiology, visible patterns, and important considerations for clinical and laboratory evaluation of acne vulgaris (AV) in adult women was provided. Proper selection and integration of skin care products is important in the management of AV in this patient population. Part 2 of this series includes a discussion of over-the-counter and prescription topical therapies for adult women with AV. A summary of key randomized controlled trials also is provided. Further well-designed studies are needed, as data on the use of topical agents in this subpopulation are limited. PMID:26682555

  12. New regulations for oral contraceptive prescription in France in 2013: what is the impact on adult female acne?

    PubMed

    Leclerc-Mercier, Stéphanie; Buisson, Virginie; Dreno, Brigitte

    2016-08-01

    In 2012, a young French woman lodged a complaint against a pharmaceutical company having suffered a cerebral stroke. The French health authority recommended all prescribers of hormonal contraception (HCP) to favour second-generation HCP. To evaluate the consequences of these recommendations on female acne. A prospective multicentre study using a standardised questionnaire completed by 1,724 women. The mean age was 26.57 years; 58.7% of the women had changed their HCP during the last 12 months. The initial ratio of first or second/third or fourth-generation drugs was 5.5%/82.9% which changed after the recommendations to 70.6%/29.4%. Among the patients who switched from third or fourth to first or second-generation drugs, 83.9% considered that their acne had worsened (p<0.0001). In those patients who received a local acne treatment, 72.1% had additional systemic treatment. This study confirms the important rise in prescriptions of first or second-generation HCP. This switch has resulted in a significant increase in acne, requiring treatment for the large majority of patients, thus confirming the role of a hormonal factor in female acne. PMID:27312707

  13. The validation of analytical methods for drug substances and drug products in UK pharmaceutical laboratories.

    PubMed

    Clarke, G S

    1994-05-01

    Results of a survey on method validation of analytical procedures used in the testing of drug substances and finished products, of most major research based pharmaceutical companies with laboratories in the UK, are presented. The results indicate that although method validation shows an essential similarity in different laboratories (in particular, chromatographic assay methods are validated in a similar manner in most laboratories), there is much diversity in the detailed application of validation parameters. Testing procedures for drug substances are broadly similar to finished products. Many laboratories validate methods at clinical trial stage to the same extent and detail as at the marketing authorization application (MAA)/new drug application (NDA) submission stage, however, only a small minority of laboratories apply the same criteria to methodology at pre-clinical trial stage. Extensive details of method validation parameters are included in the summary tables of this survey, together with details of the median response given for the validation of the most extensively applied methods. These median response details could be useful in suggesting a harmonized approach to method validation as applied by UK pharmaceutical laboratories. These guidelines would extend beyond the recommendations made to date by regulatory authorities and pharmacopoeias in that minimum requirements for each method validation parameter, e.g. number of replicates, range and tolerance, could be harmonized, both between laboratories and also in Product Licence submissions. PMID:7948185

  14. Therapeutic considerations for severe nodular acne.

    PubMed

    Newman, Marissa D; Bowe, Whitney P; Heughebaert, Carol; Shalita, Alan R

    2011-02-01

    Severe nodular acne, defined as grade 4 or 5 acne on the Investigator's Static Global Assessment scale, is a skin condition characterized by intense erythema, inflammation, nodules, cysts, and scarring. Both the well known risk of physical scarring and the more recent recognition that acne can be a chronic, psychologically distressing disease with significant adverse effects on a patient's quality of life, have prompted earlier, more aggressive treatment with more effective medications, in the hope of preventing progression to more severe, nodular forms of the disease. Oral antibacterials, primarily tetracyclines, have long been the first-line therapy for severe nodular acne, which frequently remained refractory to therapy. However, concerns of antibacterial adverse effects, patient adherence, and antimicrobial resistance prompted the search for alternate therapies and combinations thereof in order to target the multifactorial pathogenesis of the disease. Isotretinoin, an oral retinoid introduced in 1982, has since become the gold standard therapy in severe acne and has revolutionized its treatment. Several adjunctive agents exist. Oral antibacterials are indicated as an alternative for patients with severe acne who cannot tolerate oral retinoids, or for whom a contraindication exists. In order to prevent bacterial resistance, antibacterials should always be used in combination with benzoyl peroxide, a nonantibiotic antimicrobial agent with anti-inflammatory activity. Topical retinoids are often added to this regimen. In women, hormonal agents, which include oral contraceptives, spironolactone, and oral corticosteroids, and, in Europe, cyproterone acetate, may be used as monotherapy or concomitantly with isotretinoin. For rapid treatment of inflammatory nodules, intralesional corticosteroids are effective. These treatment modalities have been studied, refined, and combined in novel ways in order to target the multifactorial pathogenesis of the disease, and in this

  15. Addressing Free Radical Oxidation in Acne Vulgaris

    PubMed Central

    Criscito, Maressa C.; Schlesinger, Todd E.; Verdicchio, Robert; Szoke, Ernest

    2016-01-01

    Objective: Comparatively little attention has been paid to the role of free radical oxidation in acne vulgaris. Here, using the traditional abnormalities cited for acne, the authors address the role of free radical oxidation throughout the pathogenesis by detailing the chemistry that may contribute to clinical changes. To probe the effects of free radical oxidation and test an antioxidant, they conducted a preliminary study of topically applied vitamin E. Methods: Seventeen patients with mild-to-moderate acne vulgaris were evaluated over an eight-week period in two private dermatology practices in this open-label study. All patients enrolled were on the same baseline regimen of salicylic acid and benzoyl peroxide. This regimen was then supplemented with topical vitamin E in sunflower seed oil. Results: At the end of the eight-week period, all patients demonstrated clinical improvement, as indicated by a reduction in the number of lesions and global mean difference. A statistically significant reduction was noted as early as Week 2. Enrolled patients also expressed a positive experience due to good tolerability and easy application. Conclusion: Although the exact pathogenesis of acne vulgaris remains unknown, the presence of excessive reactive oxygen species can be implicated in each of the major abnormalities involved. This presence, along with the positive results of the authors’ preliminary study, demonstrates the need for more exploration on the use of topical antioxidants in limiting free radical oxidation in the acne model. This paper is designed to stimulate academic discussion regarding a new way of thinking about the disease state of acne. PMID:26962389

  16. Colloidal carriers of isotretinoin for topical acne treatment: skin uptake, ATR-FTIR and in vitro cytotoxicity studies.

    PubMed

    Gürbüz, Aslı; Özhan, Gül; Güngör, Sevgi; Erdal, M Sedef

    2015-09-01

    Acne vulgaris is the chronical, multifactorial and complex disease of the pilosebaceous unit in the skin. The main goal of the topical therapy in acne is to target the drug to epidermal and deep dermal regions by minimizing systemic absorption . Isotretinoin, a retinoic acid derivative, is the most effective drug in acne pathogenesis. Because systemic treatment may cause many side effects, topical isotretinoin treatment is an option in the management of acne. However, due to its high lipophilic character, isotretinoin tends to accumulate in the upper stratum corneum, thus its penetration into the lower layers is limited, which restricts the efficiency of topical treatment. Microemulsions are fluid, isotropic, colloidal drug carriers that have been widely studied as drug delivery systems. The percutaneous transport of active agents can be enhanced by microemulsions when compared with their conventional formulations. The purpose of this study was to evaluate microemulsions as alternative topical carriers for isotretinoin with an objective to improve its skin uptake. After in vitro permeation studies, the dermal penetration of isotretinoin from microemulsions was investigated by tape stripping procedure. Confocal laser scanning microscopy provided insight about the localization of the drug in the skin. The interaction between the microemulsion components and stratum corneum lipids is studied by ATR-FTIR spectroscopy. The relative safety of the microemulsions was assessed in mouse embryonic fibroblasts using MTT viability test. The results indicate that microemulsion-based novel colloidal carriers have a potential for enhanced skin delivery and localization of isotretinoin. PMID:25903443

  17. Drugs for solid cancer: the productivity crisis prompts a rethink

    PubMed Central

    Rösel, Daniel; Brábek, Jan; Veselý, Pavel; Fernandes, Michael

    2013-01-01

    Despite remarkable progress in cancer-drug discovery, the delivery of novel, safe, and sustainably effective products to the clinic has stalled. Using Src as a model, we examine key steps in drug development. The preclinical evidence on the relationship between Src and solid cancer is in sharp contrast with the modest anticancer effect noted in conventional clinical trials. Here, we consider Src inhibitors as an example of a promising drug class directed to invasion and metastasis and identify roadblocks in translation. We question the assumption that a drug-induced tumor shrinkage in preclinical and clinical studies predicts a successful outcome. Our analysis indicates that the key areas requiring attention are related, and include preclinical models (in vitro and mouse models), meaningful clinical trial end points, and an appreciation of the role of metastasis in morbidity and mortality. Current regulations do not reflect the natural history of the disease, and may be unrelated to the key complications: local invasion, metastasis, and the development of resistance. Alignment of preclinical and clinical studies and regulations based on mechanistic trial end points and platforms may help in overcoming these roadblocks. Viewed kaleidoscopically, most elements necessary and sufficient for a novel translational paradigm are in place. PMID:23836990

  18. Severe teenage acne and risk of endometriosis

    PubMed Central

    Xie, Jing; Kvaskoff, Marina; Li, Yunhui; Zhang, Mingfeng; Qureshi, Abrar A.; Missmer, Stacey A.; Han, Jiali

    2014-01-01

    STUDY QUESTION Is there a relationship between severe teenage acne and endometriosis? SUMMARY ANSWER Endometriosis is positively associated with severe teenage acne. WHAT IS KNOWN ALREADY No studies have specifically explored a possible association between severe acne in adolescence and risk of endometriosis. STUDY DESIGN, SIZE, DURATION This prospective cohort study used data collected from 88 623 female nurses from September 1989 to June 2009 as part of the Nurses' Health Study II (NHS II) cohort. PARTICIPANTS/MATERIALS, SETTING, METHODS Regression models were used to calculate hazard ratios (HRs) and confidence intervals (CIs) for endometriosis among women with and without severe teenage acne. Multivariate models were adjusted for established risk factors of endometriosis. MAIN RESULTS AND THE ROLE OF CHANCE A total of 4 382 laparoscopically confirmed endometriosis cases were documented during 1 132 272 woman-years of follow-up. Compared with women without a history of severe teenage acne, women who had severe teenage acne had a 20% increased risk of endometriosis (HR = 1.20, 95% CI: 1.08–1.32). The association was not affected by adjusting for use of tetracycline or isotretinoin. LIMITATIONS AND REASONS FOR CAUTION The HR is likely to be underestimated since we only included endometriosis cases confirmed by laparoscopy. Although geographically diverse, the NHS II cohort is primarily Caucasian, which may limit generalization to more ethnically diverse populations. WIDER IMPLICATIONS OF THE STUDY The results of this study suggest that severe teenage acne is associated with an increased risk of endometriosis. As a visible and non-invasive clinical indicator, severe teenage acne may be useful for early detection of endometriosis. We bring this counter-intuitive association to the attention of clinicians for the benefit of the patient and an early diagnosis of endometriosis. STUDY FUNDING/COMPETING INTEREST This study was funded by research grant CA176726 from the

  19. Acne Inversa: Evaluating Antimicrobial Peptides and Proteins

    PubMed Central

    Sand, Michael; Skrygan, Marina; Kreuter, Alexander; Altmeyer, Peter; Gambichler, Thilo

    2012-01-01

    Background Acne inversa is a chronic, suppurative relapsing inflammatory skin disease that primarily affects the axillae, perineum and inframammary regions. Evidence suggests that the innate immune system is involved in the pathogenesis of acne inversa. Objective To investigate the role of the innate immune system in acne inversa. Methods Skin biopsies were obtained from inflammatory skin lesions (n=17) and from non-lesional skin (intraindividual control, n=17) of patients with acne inversa. Additional skin lesions were taken from patients with chronic venous leg ulcers (interindividual control, n=5). Quantitative real-time reverse transcription-polymerase chain reaction was used to determine the mRNA levels of antimicrobial peptides and proteins (AMPs), including human β-defensin (hBD)-1, hBD-2 and hBD-3, LL-37 (cathelicidin) and Ribonuclease 7 (RNase 7). mRNA levels were also determined for inflammatory and anti-inflammatory cytokines, including tumor necrosis factor-alpha (TNF-α), matrix metalloproteinase-1 (MMP1), interleukin (IL)-1β, IL-6, IL-8 and IL-10. Results The mRNA levels of hBD-2, LL-37, IL-1β, IL-6, IL-8, IL-10 and MMP1 were significantly higher in acne inversa lesions compared to non-lesional skin (p<0.05). A significant positive correlation expression was observed between hBD-2 mRNA expression and LL-37 (ρ=0.53, p=0.03), and between hBD-2 and RNAse 7 (ρ=0.68, p=0.006). When compared to the chronic venous leg ulcer lesions, acne inversa lesions showed a significantly higher expression of RNase 7 mRNA, while IL-1 β, IL-6, IL-8, TNF-α and MMP1 mRNA expression was significantly higher in the chronic venous leg ulcer lesions (p<0.05). Conclusion The AMP, cytokine milieu and tissue proteases in acne inversa lesions differ significantly from non-lesional skin and chronic venous leg ulcers. The positively correlating up-regulation of AMPs in acne inversa indicates an important role of the innate immune system in the pathogenesis of this disorder

  20. Bilateral sequential Propionibacterium acnes exogenous endophthalmitis.

    PubMed

    Saffra, Norman; Moriarty, Emily; Milman, Tatyana

    2016-12-01

    A 68-year-old man underwent uncomplicated sequential cataract extractions performed more than a year apart. He presented 6 months after the second surgery with persistent intraocular inflammation in both eyes. Cultures from both eyes grew Propionibacterium acnes and he responded well to treatment. Suspicion for delayed-onset post-operative endophthalmitis must remain high in uveitis cases that fail to resolve with anti-inflammatory treatments. The authors believe this is the first reported case of bilateral sequential P. acnes exogenous endophthalmitis. PMID:27220771

  1. 21 CFR 20.2 - Production of records by Food and Drug Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... records by Food and Drug Administration employees. (a) Any request for records of the Food and...

  2. 21 CFR 211.89 - Rejected components, drug product containers, and closures.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED...

  3. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... of PET drugs? (a) Record availability. Records must be maintained at the PET drug production facility... loss, and readily available for review and copying by FDA employees. (c) Record retention period....

  4. 21 CFR 314.92 - Drug products for which abbreviated applications may be submitted.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... offered for sale by its manufacturer, a person who wishes to submit an abbreviated new drug application... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Drug products for which abbreviated applications may be submitted. 314.92 Section 314.92 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT...

  5. 21 CFR 211.89 - Rejected components, drug product containers, and closures.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED...

  6. 21 CFR 211.89 - Rejected components, drug product containers, and closures.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED...

  7. 21 CFR 211.89 - Rejected components, drug product containers, and closures.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED...

  8. 21 CFR 211.89 - Rejected components, drug product containers, and closures.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED...

  9. 21 CFR 358.350 - Labeling of ingrown toenail relief drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... 358.350 Section 358.350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN... and the skin meet. Smooth ring down firmly. apply enough gel product to fill the slot in the...

  10. 21 CFR 357.152 - Package inserts for anthelmintic drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Package inserts for anthelmintic drug products... SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER...

  11. Computer-Aided Drug Design of Bioactive Natural Products.

    PubMed

    Prachayasittikul, Veda; Worachartcheewan, Apilak; Shoombuatong, Watshara; Songtawee, Napat; Simeon, Saw; Prachayasittikul, Virapong; Nantasenamat, Chanin

    2015-01-01

    Natural products have been an integral part of sustaining civilizations because of their medicinal properties. Past discoveries of bioactive natural products have relied on serendipity, and these compounds serve as inspiration for the generation of analogs with desired physicochemical properties. Bioactive natural products with therapeutic potential are abundantly available in nature and some of them are beyond exploration by conventional methods. The effectiveness of computational approaches as versatile tools for facilitating drug discovery and development has been recognized for decades, without exception, in the case of natural products. In the post-genomic era, scientists are bombarded with data produced by advanced technologies. Thus, rendering these data into knowledge that is interpretable and meaningful becomes an essential issue. In this regard, computational approaches utilize the existing data to generate knowledge that provides valuable understanding for addressing current problems and guiding the further research and development of new natural-derived drugs. Furthermore, several medicinal plants have been continuously used in many traditional medicine systems since antiquity throughout the world, and their mechanisms have not yet been elucidated. Therefore, the utilization of computational approaches and advanced synthetic techniques would yield great benefit to improving the world's health population and well-being. PMID:25961523

  12. Efficacy of local application of an Unani formulation in acne vulgaris

    PubMed Central

    Sultana, Shabiya; Zulkifle, Mohd.; Ansari, Abdul Haseeb; Shahnawaz

    2015-01-01

    Background and Objectives: Buthūr-i-Labaniyya (Acne vulgaris) is affecting up to 80% of adolescents and many adults at different stages of life. It is one of the commonest skin disorders which appears on cheeks and nose as white eruptions that seems like solidified milk drops. These eruptions are treated by drugs having properties of tajfīf wa taḥlīl (desiccant and resolving), as mentioned by Ibne Sina. Daood Antaki in his book Tazkira Oolulalbab recommends the local application of a paste of Shonīz (nigella sativa), Naushādar (ammonium chloride) and Būra Armani mixed with Sirka (vinegar) for effective treatment of Acne vulgaris. Methods: The study was observational self comparison before and after treatment, conducted in the OPD of the hospital which is part of the National Institute of Unani Medicine, Bangalore. The duration of study was one year. 40 Female patients with combination of comedones, papules, pustules and nodules were recruited for this purpose. The test drug, Shonīz, Būra Armani, Naushadar powder, mixed with sirka were applied locally for one month with taqlīl-i-ghidhā tadābīr (low calorie index diet). All subjects were assessed on the basis of changes in subjective and objective parameters. Results: The response of test drugs was statistically highly significant (P < 0.01) by using ANOVA repeated measure test, there was also relief in subjective parameters. Subjects reported a reduction of 82.6%, 80.9%, 66.6% in tenderness, itching and irritation respectively. Interpretation and Conclusion: The present study reveals that the test drug formulation is safe and effective in treating Acne vulgaris if used along with low calorie index diet. No side effects of drugs were reported, therefore the trial formulation can be recommended to manage Acne vulgaris of mild to severe degree as a therapy. PMID:26865747

  13. Biotechnological aspects of the production of the anticancer drug podophyllotoxin.

    PubMed

    Farkya, Sunita; Bisaria, V S; Srivastava, A K

    2004-10-01

    The natural lignan podophyllotoxin, a dimerized product of two phenylpropanoid moieties which occurs in a few plant species, is a pharmacologically important compound for its anticancer activities. It is used as a precursor for the chemical synthesis of the anticancer drugs etoposide, teniposide and etopophose. The availability of this lignan is becoming increasingly limited because of the scarce occurrence of its natural sources and also because synthetic approaches for its production are still commercially unacceptable. Biotechnological production using cell culture may be considered as an alternative source. Selection of the best performing cell line, its maintenance and stabilization are necessary prerequisites for its production in bioreactors and subsequent scale-up of the cultivation process to the industrial level. Scale-up of growth and product yield depends on a multitude of factors, such as growth medium, physicochemical conditions, seed inoculum, type of reactor and processing conditions. The composition of the growth medium, elicitors and precursors, etc. can markedly influence the production. Optimum levels of parameters that facilitate high growth and product response in cell suspensions of Podophyllum hexandrum have already been determined by statistical design. P. hexandrum cells have successfully been cultivated in a 3-l stirred-tank bioreactor under low shear conditions in batch and fed-batch modes of operation. The batch kinetic data were used to identify the mathematical model which was then used to develop nutrient-feeding strategies for fed-batch cultivation to prolong the productive log phase of cultivation. An improvement in the production of podophyllotoxin to 48.8 mg l(-1) in a cell culture of P. hexandrum was achieved, with a corresponding volumetric productivity of 0.80 mg l(-1) day(-1), when the reactor was operated in continuous cell-retention mode. Efforts are being made to further enhance its production levels by the development of

  14. Fluorescence guided evaluation of photodynamic therapy as acne treatment

    NASA Astrophysics Data System (ADS)

    Ericson, Marica B.; Horfelt, Camilla; Cheng, Elaine; Larsson, Frida; Larko, Olle; Wennberg, Ann-Marie

    2005-08-01

    Photodynamic therapy (PDT) is an attractive alternative treatment for patients with acne because of its efficiency and few side effects. Propionibacterium acnes (P.acnes) are bacteria present in the skin, which produce endogenous porphyrins that act as photosensitisers. In addition, application of aminolaevulinic acid or its methyl ester (mALA) results in increased accumulation of porphyrins in the pilosebaceous units. This makes it possible to treat acne with PDT. This initial study investigates the possibility of fluorescence imaging as assessment tool in adjunct to PDT of patients with acne. Twenty-four patients with acne on the cheeks have been treated with PDT with and without mALA. Fluorescence images have been obtained before and after treatment. The clinical acne score was assessed as base line before PDT, and at every follow up visit. Additionally the amount of P.acnes was determined. The clinical evaluation showed a general improvement of acne, even though no difference between treatment with and without mALA was observed. By performing texture analysis and multivariate data analsysis on the fluorescence images, the extracted texture features were found to correlate with the corresponding clinical assessment (67%) and amount of P.acnes (72%). The analysis showed that features describing the highly fluorescent pores could be related to the clinical assessment. This result suggests that fluorescence imaging can be used as an objective assessment of acne, but further improvement of the technique is possible, for example by including colour images.

  15. Propionibacterium acnes as a cause of lung abscess in a cardiac transplant recipient.

    PubMed

    Veitch, David; Abioye, Abu; Morris-Jones, Stephen; McGregor, Alastair

    2015-01-01

    A 29-year-old man was admitted with fevers, cough, left-sided chest pain and lethargy for 1 week. He had a cardiac transplant 10 years prior and was on immunosuppressive drugs. He was found to have a pulmonary lesion and went on to develop a lung abscess. Propionibacterium acnes was identified on matrix-assisted laser desorption ionisation mass spectrometry-time of flight and 16s rRNA gene sequencing after drainage. He was curatively treated with co-trimoxazole and co-amoxiclav. He divulged a longstanding history of seborrhoeic dermatitis with frequent flares leading to large volumes of squames collecting on his bed sheets. We hypothesise this was a possible route of entry: inhalation of the Propionibacterium. This case highlights how a common commensal bacterium, P. acnes, was able to cause pathology in an immunosuppressed patient. This is the only case of a patient with transplantation developing a P. acnes pulmonary infection and the only case of P. acnes causing these clinical features to be reported in the literature. PMID:26677153

  16. Characterization of a new acne vulgaris treatment device combining light and thermal treatment methods

    PubMed Central

    Joo, Yeail; Kang, Heesung; Choi, Eung Ho; Nelson, J. Stuart; Jung, Byungjo

    2012-01-01

    Background/purpose Conventional treatment methods for acne vulgaris have various side effects such as the development of bacterial resistance, phototoxicity, vertigo, gastro-intestinal problems, and drug eruptions. To minimize such side effects, light and thermal methods have been alternately suggested. This study characterized a new acne vulgaris treatment device (AVTD) that combines both light and thermal methods and evaluated its clinical efficacy. Methods We characterized the thermal and light properties of the AVTD itself and evaluated its thermal characteristics in ex vivo porcine skin samples. The Arrhenius equation was used to calculate the skin thermal injury coefficient to confirm the skin safety of the AVTD. Finally, the clinical efficacy of the AVDT was evaluated by analyzing cross-polarization and erythema index images, which were obtained from 13 volunteers undergoing treatment with the AVTD. Results The temperature of the AVTD itself was maintained at 49.1 °C on the tip and 39.7 °C in the porcine skin samples. The peak intensity of the light-emitting diode (LED) light was observed at 468 nm. The skin safety of the AVTD was confirmed and 84.2% of the volunteers presented positive treatment results. Conclusion The treatment of acne using the AVTD resulted in a high treatment rate in a clinical study, minimizing side effects. On the basis of these results, we can be sure that the AVTD may be effectively used for the treatment of acne vulgaris. PMID:21585558

  17. Acne in the adult female patient: a practical approach.

    PubMed

    Kamangar, Faranak; Shinkai, Kanade

    2012-10-01

    Acne vulgaris is a common reason why adult women present to dermatologists and can be a clinical challenge to treat. It may also be an important sign of an underlying endocrine disease such as Polycystic Ovary Syndrome (PCOS). Although standard acne therapies can be successfully used to treat acne in adult female patients, hormonal treatment is a safe and effective therapeutic option that may provide an opportunity to better target acne in this population, even when other systemic therapies have failed. In this article, a practical approach to the adult female patient with acne will be reviewed to enhance the dermatologist's ability to use hormonal acne therapies and to better identify and evaluate patients with acne in the setting of a possible endocrine disorder. PMID:22994662

  18. Alexithymia and Acne Vulgaris: A Case Control Study

    PubMed Central

    Baykir, Murat; Ateş, Gülfem; Ekşioğlu, Meral

    2011-01-01

    Objective To assess relationship between alexithymia and acne vulgaris in young people. Methods A hundred and eleven subjects between 15 and 25 years of age referred to out-patient clinic of dermatology with acne and 78 subjects applied to family physician for complaints other than acne were included in patient and control groups of the study, respectively. A questionnaire to determine demographic characteristics, an acne classification to determine severity of acne and Toronto Alexithymic Scale (TAS) to assess alexithymia were used. Results The mean scores of TAS were 52.7±10.8 and 51.7±10.7 in patient and control groups, respectively. Alexitymia was determined in 23.4% of the subjects in acne group and in 24.4% of control group. No significant differences were found between groups in terms of alexithymia, intermediate alexitymia and three-factors of TAS. Conclusion Alexithymia does not appear to be related to acne vulgaris. PMID:22216042

  19. Significance of diet in treated and untreated acne vulgaris.

    PubMed

    Kucharska, Alicja; Szmurło, Agnieszka; Sińska, Beata

    2016-04-01

    The relationship between diet and acne is highly controversial. Several studies during the last decade have led dermatologists to reflect on a potential link between diet and acne. This article presents the latest findings on a potential impact that diet can have on pathogenesis of acne vulgaris. The association between diet and acne can no longer be dismissed. Compelling evidence shows that high glycemic load diets may exacerbate acne. Dairy ingestion appears to be weakly associated with acne and the roles of omega-3 fatty acids, dietary fiber, antioxidants, vitamin A, zinc and iodine remain to be elucidated. The question of what the impact of diet is on the course of acne vulgaris still remains unclear. PMID:27279815

  20. Significance of diet in treated and untreated acne vulgaris

    PubMed Central

    Szmurło, Agnieszka; Sińska, Beata

    2016-01-01

    The relationship between diet and acne is highly controversial. Several studies during the last decade have led dermatologists to reflect on a potential link between diet and acne. This article presents the latest findings on a potential impact that diet can have on pathogenesis of acne vulgaris. The association between diet and acne can no longer be dismissed. Compelling evidence shows that high glycemic load diets may exacerbate acne. Dairy ingestion appears to be weakly associated with acne and the roles of omega-3 fatty acids, dietary fiber, antioxidants, vitamin A, zinc and iodine remain to be elucidated. The question of what the impact of diet is on the course of acne vulgaris still remains unclear. PMID:27279815

  1. [Instrumental analysis of medicinal plants and their drug products].

    PubMed

    Petri, G; Lemberkovics, E

    1994-05-01

    The experiences obtained during the development of gas chromatographic and other (GC, TLC and infrared spectrophotometric) methods for the 7th edition of the Hungarian Pharmacopoeia for essential oils and drugs containing essential oils are summarized with emphasis on the selection of suitable internal standard for the gas chromatographic assays. The qualitative and quantitative estimation of bitter compounds and polyphenoles e.g. flavonoids and procyanidines by means of ultraviolet and infrared spectrophotometry and HPLC is also described. Some HPLC methods for the determination of anthocyan and carotinoid derivatives are also presented. These are not yet included in the pharmacopoeia but are successfully used for the analytical investigation of commercially available medicinal plants and drug products made thereof. PMID:7942042

  2. Towards integrated drug substance and drug product design for an active pharmaceutical ingredient using particle engineering.

    PubMed

    Kougoulos, Eleftherios; Smales, Ian; Verrier, Hugh M

    2011-03-01

    A novel experimental approach describing the integration of drug substance and drug production design using particle engineering techniques such as sonocrystallization, high shear wet milling (HSWM) and dry impact (hammer) milling were used to manufacture samples of an active pharmaceutical ingredient (API) with diverse particle size and size distributions. The API instability was addressed using particle engineering and through judicious selection of excipients to reduce degradation reactions. API produced using a conventional batch cooling crystallization process resulted in content uniformity issues. Hammer milling increased fine particle formation resulting in reduced content uniformity and increased degradation compared to sonocrystallized and HSWM API in the formulation. To ensure at least a 2-year shelf life based on predictions using an Accelerated Stability Assessment Program, this API should have a D [v, 0.1] of 55 μm and a D [v, 0.5] of 140 μm. The particle size of the chief excipient in the drug product formulation needed to be close to that of the API to avoid content uniformity and stability issues but large enough to reduce lactam formation. The novel methodology described here has potential for application to other APIs. PMID:21246419

  3. Make-up improves the quality of life of acne patients without aggravating acne eruptions during treatments.

    PubMed

    Hayashi, Nobukazu; Imori, Mizuho; Yanagisawa, Midori; Seto, Yoko; Nagata, Osamu; Kawashima, Makoto

    2005-01-01

    Boehncke et al. suggested that decorative cosmetics can improve the quality of life (QOL) of skin diseases. But dermatologists sometimes discourage female acne patients from applying make-up since decorative cosmetics are considered one of the aggravating factors for acne eruptions. The purpose of this study is to assess whether make-up application interferes with acne treatments and how QOL changes when the make-up items are designed for acne patients and used in order to disguise acne eruptions. Eighteen female acne patients were trained by a make-up artist and advised to apply acne-designed basic and decorative cosmetics for 2 to 4 weeks while their acne was appropriately treated. The acne-severity and QOL of patients were assessed before and after the study. The results revealed that the number of acne eruptions decreased even though patients were applying make-up. The QOL scores of Skindex-16, GHQ30 and anxiety state index greatly improved. Our results suggest that dermatologists should encourage acne patients to utilize appropriate make-up to improve their QOL. PMID:16048760

  4. Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation.

    PubMed

    Babiskin, Andrew H; Zhang, Xinyuan

    2015-09-01

    Amphetamine (AMP) salts-based extended-release (ER) drug products are widely used for the treatment of attention deficit hyperactivity disorder. We developed physiologically based absorption models for mixed AMP salts ER capsules and dextroamphetamine sulfate ER capsules to address specific questions raised during generic drug postmarketing surveillance and bioequivalence (BE) guidance development. The models were verified against several data sets. Virtual BE simulations were conducted to assess BE in various populations other than normal healthy subjects where BE studies are generally conducted for approval. The models were also used to predict pharmacokinetics (PK) for hypothetical formulations having dissolution profiles falling within specification after the development of in vitro-in vivo relation. Finally, we demonstrated how to use the models to test sensitivity of PK metrics to the changes in formulation variables. PMID:25973928

  5. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.

    PubMed

    Choi, Stephanie H; Lionberger, Robert A

    2016-07-01

    For ophthalmic drug products, the determination of bioequivalence can be challenging, as drug concentrations at the site of action cannot always be measured. The FDA has recommended a variety of studies that can be used to demonstrate bioequivalence for different ophthalmic drug products. Product-specific bioequivalence recommendations for 28 ophthalmic products have been posted on FDA's website as of May 2016, outlining the specific tests which should be performed to demonstrate bioequivalence. The type of study that can be used to demonstrate bioequivalence depends on the drug product's active pharmaceutical ingredient(s), dosage form, indication, site of action, mechanism of action, and scientific understanding of drug release/drug availability and drug product characteristics. This article outlines the FDA's current guidance on studies to demonstrate bioequivalence through clinical endpoint studies, pharmacokinetic studies, and in vitro studies for generic ophthalmic drug products. PMID:27184578

  6. Hormonal correlates of acne and hirsutism.

    PubMed

    Lucky, A W

    1995-01-16

    Acne is a multifactorial disorder reflecting the role of infection, abnormal keratinization and immunologic reaction, as well as hormonal influences, on the pilosebaceous unit. Clinical studies have correlated elevated levels of androgens, originating in both the adrenal glands and ovaries, with acne. These include total and free testosterone, delta 4-androstenedione, dehydroepiandrosterone and its sulfate, and low levels of sex hormone binding globulin. The pathogenesis of acne initiation in childhood has been linked to rising serum levels of dehydroepiandrosterone sulfate. Hirsutism has been more directly correlated with increased levels of serum androgens, notably free testosterone. Underlying causes of elevated androgens in both disorders include very rare tumors, partial or late-onset forms of congenital adrenal hyperplasia, developmental adrenal abnormalities and, most commonly, polycystic ovary syndrome. Early acne treatment may include topical benzoyl peroxide, antibiotics, and tretinoin. More severe disease can be treated systemically (with antibiotics and/or isotretinoin). Very-low-dose corticosteroids can be used to eliminate the adrenal component of hyperandrogenism. Oral contraceptives, especially those that contain low-androgenic progestins, can reduce excessive androgens from any source and specifically suppress the ovary in polycystic ovary syndrome. Gonadotropin-releasing hormone agonists, with or without estrogen supplementation, and systemic or topical antiandrogens may play a more important role in the future. PMID:7825645

  7. Topical and oral antibiotics for acne vulgaris.

    PubMed

    Del Rosso, James Q

    2016-06-01

    Antibiotics, both oral and topical, have been an integral component of the management of acne vulgaris (AV) for approximately 6 decades. Originally thought to be effective for AV due to their ability to inhibit proliferation of Propionibacterium acnes, it is now believed that at least some antibiotics also exert anti-inflammatory effects that provide additional therapeutic benefit. To add, an increase in strains of P acnes and other exposed bacteria that are less sensitive to antibiotics used to treat AV have emerged, with resistance directly correlated geographically with the magnitude of antibiotic use. Although antibiotics still remain part of the therapeutic armamentarium for AV treatment, current recommendations support the following when used to treat AV: 1) monotherapy use should be avoided; 2) use benzoyl peroxide concomitantly to reduce emergence of resistant P acnes strains; 3) oral antibiotics should be used in combination with a topical regimen for moderate-to-severe inflammatory AV; and 4) use oral antibiotics over a limited duration to achieve control of inflammatory AV with an exit plan in place to discontinue their use as soon as possible. When selecting an oral antibiotic to treat AV, potential adverse effects are important to consider. PMID:27416309

  8. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING Compounded Drug Products § 216.24 Drug...

  9. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING Compounded Drug Products § 216.24 Drug...

  10. 78 FR 57397 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Announcement of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash Products; Announcement of Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

  11. ICG laser therapy of acne vulgaris

    NASA Astrophysics Data System (ADS)

    Tuchin, Valery V.; Altshuler, Gregory B.; Genina, Elina A.; Bashkatov, Alexey N.; Simonenko, Georgy V.; Odoevskaya, Olga D.; Yaroslavsky, Ilya V.

    2004-07-01

    The near-infrared (NIR) laser radiation due to its high penetration depth is widely used in phototherapy. In application to skin appendages a high selectivity of laser treatment is needed to prevent light action on surrounding tissues. Indocyanine Green (ICG) dye may provide a high selectivity of treatment due to effective ICG uploading by a target and its narrow band of considerable absorption just at the wavelength of the NIR diode laser. The goal of this study is to demonstrate the efficacy of the NIR diode laser phototherapy in combination with topical application of ICG suggested for soft and thermal treatment of acne vulgaris. 28 volunteers with facile or back-located acne were enrolled. Skin sites of subjects were stained by ICG and irradiated by NIR laser-diode light (803 or 809 nm). Untreated, only stained and only light irradiated skin areas served as controls. For soft acne treatment, the low-intensity (803 nm, 10 - 50 mW/cm2, 5-10 min) or the medium-intensity (809 nm, 150 - 190 mW/cm2, 15 min) protocols were used. The single and multiple (up to 8-9) treatments were provided. The individual acne lesions were photothermally treated at 18 W/cm2 (803 nm, 0.5 sec) without skin surface cooling or at 200 W/cm2 (809 nm, 0.5 sec) with cooling. The results of the observations during 1-2 months after the completion of the treatment have shown that only in the case of the multiple-wise treatment a combined action of ICG and NIR irradiation reduces inflammation and improves skin state during a month without any side effects. At high power densities (up to 200 W/cm2) ICG stained acne inflammatory elements were destructed for light exposures of 0.5 sec. Based on the concept that hair follicle, especially sebaceous gland, can be intensively and selectively stained by ICG due to dye diffusion through pilosebaceous canal and its fast uptake by living microorganisms, by vital keratinocytes of epithelium of the canal and sebaceous duct, and by rapidly proliferating

  12. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled...

  13. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled...

  14. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled...

  15. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled...

  16. Excipients and additives: hidden hazards in drug products and in product substitution.

    PubMed Central

    Napke, E; Stevens, D G

    1984-01-01

    The excipients and additives in drug formulations have been described as inert because they do not have an active role in the prevention or treatment of particular ailments. This has led to the misconception among physicians, pharmacists, drug manufacturers and the public that excipients are harmless and unworthy of mention. In fact, pharmacists are allowed to substitute drug formulations, without regard to the excipients, as long as they ensure that the active ingredients in the substitute are the same as those in the formulation prescribed. The inappropriateness of the term inert is becoming increasingly apparent as evidence of adverse reactions--some fatal--to excipients mounts. The likelihood that some "active" constituents, particularly erythromycin, have been blamed for such reactions deserves to be investigated. The public deserves to be better protected. For example, the United States has legislation requiring complete labelling of all food, drugs and cosmetics that incorporate more than one ingredient, no matter how innocuous the constituents are believed to be. In Canada, drug manufacturers are not even required to share this information with physicians or pharmacists when they introduce a new drug or reformulate a product already being marketed, nor are pharmacists required to disclose the contents of formulations that they prepare in the absence of commercially available products. PMID:6498699

  17. Antibiotics, Acne, and Staphylococcus aureus Colonization

    PubMed Central

    Fanelli, Matthew; Kupperman, Eli; Lautenbach, Ebbing; Edelstein, Paul H.; Margolis, David J.

    2011-01-01

    Objectives To determine the frequency of Staphylococcus aureus colonization among patients with acne and to compare the susceptibility patterns between the patients who are using antibiotics and those who are not using antibiotics. Design Survey (cross-sectional) study of patients treated for acne. Setting Dermatology outpatient office practice Participants The study included 83 patients who were undergoing treatment and evaluation for acne. Main Outcome Measure Colonization of the nose or throat with S aureus. Results A total of 36 of the 83 participants (43%) were colonized with S aureus. Two of the 36 patients (6%) had methicillin-resistant S aureus; 20 (56%) had S aureus solely in their throat; 9 (25%) had S aureus solely in their nose; and 7 (19%) had S aureus in both their nose and their throat. When patients with acne who were antibiotic users were compared with nonusers, the prevalence odds ratio for the colonization of S aureus was 0.16 (95% confidence interval [CI], 0.08–1.37) after 1 to 2 months of exposure and increased to 0.52 (95% CI, 0.12–2.17) after 2 months of exposure (P =.31). Many of the S aureus isolates were resistant to treatment with clindamycin and erythromycin (40% and 44%, respectively), particularly the nasal isolates. Very few showed resistance rates (<10%) to treatment with tetracycline antibiotics. Conclusion Unlike current dogma about the long-term use of antimicrobial agents, the prolonged use of tetracycline antibiotics commonly used to treat acne lowered the prevalence of colonization by S aureus and did not increase resistance to the tetracycline antibiotics. PMID:21482860

  18. Deciphering the Intracellular Fate of Propionibacterium acnes in Macrophages

    PubMed Central

    Fischer, Natalie; Mak, Tim N.; Shinohara, Debika Biswal; Sfanos, Karen S.; Meyer, Thomas F.

    2013-01-01

    Propionibacterium acnes is a Gram-positive bacterium that colonizes various niches of the human body, particularly the sebaceous follicles of the skin. Over the last years a role of this common skin bacterium as an opportunistic pathogen has been explored. Persistence of P. acnes in host tissue has been associated with chronic inflammation and disease development, for example, in prostate pathologies. This study investigated the intracellular fate of P. acnes in macrophages after phagocytosis. In a mouse model of P. acnes-induced chronic prostatic inflammation, the bacterium could be detected in prostate-infiltrating macrophages at 2 weeks postinfection. Further studies performed in the human macrophage cell line THP-1 revealed intracellular survival and persistence of P. acnes but no intracellular replication or escape from the host cell. Confocal analyses of phagosome acidification and maturation were performed. Acidification of P. acnes-containing phagosomes was observed at 6 h postinfection but then lost again, indicative of cytosolic escape of P. acnes or intraphagosomal pH neutralization. No colocalization with the lysosomal markers LAMP1 and cathepsin D was observed, implying that the P. acnes-containing phagosome does not fuse with lysosomes. Our findings give first insights into the intracellular fate of P. acnes; its persistency is likely to be important for the development of P. acnes-associated inflammatory diseases. PMID:23862148

  19. Acne Etiology and Treatments in Traditional Persian Medicine

    PubMed Central

    Shirbeigi, Leila; Oveidzadeh, Laleh; Jafari, Zahra; Fard, Monireh Sadat Motahari

    2016-01-01

    Background: Traditional Persian medicine (TPM) is based on humors theory. Temperament or mizaj is the result of a combination of four fundamental humors called blood, phlegm, yellow bile, and black bile. Like any other diseases, acne is the result of humoral imbalance. Acne is a highly prevalent dermatological problem, which has both physical and psychological effects on patients. The aim of this study was to determine the etiology of acne formation and natural remedies from the perspective of Persian scientists. Methods: The etiology and treatment of acne were collected and analyzed from selected TPM medical textbooks. Some selected plants in these books were assessed in tabular format and their anti-acne activities were compared with modern medicine’s databases. Results: In the acne treatment, considering six essential schemes for health, diet and herbal remedies as well as manipulation are recommended. Although the mentioned herbs in acne treatment have antibacterial, anti-inflammatory, and antioxidant effects; however, some have special proven effects on the acne formation process. There is also a strong relationship between the digestive system and skin. This paper was rendered to show ancient Persian scholar’s viewpoints on acne and its treatment. Conclusion: Some reported remedies might be beneficial towards further studies on acne treatment. PMID:26722141

  20. Natural Product-Derived Drugs for the Treatment of Inflammatory Bowel Diseases

    PubMed Central

    2014-01-01

    Natural products have been used as drugs for millennia, and the therapeutic potential of natural products has been studied for more than a century. Since the mid-1880s, approximately 60% of drugs have originated from natural products. Recently, the importance of using natural products has increased, as has interest in discovering efficient new drugs. Natural drugs are desirable for the treatment of inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease. This review discusses the discovery and development of drugs derived from natural products for the treatment of inflammatory bowel diseases. PMID:25349576

  1. 21 CFR 358.550 - Labeling of corn and callus remover drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 16 CFR 1500.3(b)(10). (ii) “Keep away from fire or flame.” (3) For any product formulated in a... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug...

  2. 21 CFR 358.550 - Labeling of corn and callus remover drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 16 CFR 1500.3(b)(10). (ii) “Keep away from fire or flame.” (3) For any product formulated in a... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug...

  3. 21 CFR 358.550 - Labeling of corn and callus remover drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 16 CFR 1500.3(b)(10). (ii) “Keep away from fire or flame.” (3) For any product formulated in a... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug...

  4. Analysis of Complete Genomes of Propionibacterium acnes Reveals a Novel Plasmid and Increased Pseudogenes in an Acne Associated Strain

    PubMed Central

    Fitz-Gibbon, Sorel; Tomida, Shuta; Li, Huiying

    2013-01-01

    The human skin harbors a diverse community of bacteria, including the Gram-positive, anaerobic bacterium Propionibacterium acnes. P. acnes has historically been linked to the pathogenesis of acne vulgaris, a common skin disease affecting over 80% of all adolescents in the US. To gain insight into potential P. acnes pathogenic mechanisms, we previously sequenced the complete genome of a P. acnes strain HL096PA1 that is highly associated with acne. In this study, we compared its genome to the first published complete genome KPA171202. HL096PA1 harbors a linear plasmid, pIMPLE-HL096PA1. This is the first described P. acnes plasmid. We also observed a five-fold increase of pseudogenes in HL096PA1, several of which encode proteins in carbohydrate transport and metabolism. In addition, our analysis revealed a few island-like genomic regions that are unique to HL096PA1 and a large genomic inversion spanning the ribosomal operons. Together, these findings offer a basis for understanding P. acnes virulent properties, host adaptation mechanisms, and its potential role in acne pathogenesis at the strain level. Furthermore, the plasmid identified in HL096PA1 may potentially provide a new opportunity for P. acnes genetic manipulation and targeted therapy against specific disease-associated strains. PMID:23762865

  5. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... because of minor variations in formulation. To assure the effectiveness of an antiperspirant, the Food...

  6. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... because of minor variations in formulation. To assure the effectiveness of an antiperspirant, the Food...

  7. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... because of minor variations in formulation. To assure the effectiveness of an antiperspirant, the Food...

  8. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... because of minor variations in formulation. To assure the effectiveness of an antiperspirant, the Food...

  9. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... because of minor variations in formulation. To assure the effectiveness of an antiperspirant, the Food...

  10. 21 CFR 310.528 - Drug products containing active ingredients offered over-the-counter (OTC) for use as an...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean... such drug products. Androgens (e.g., testosterone and methyltestosterone) and estrogens are...

  11. Identifying acne treatment uncertainties via a James Lind Alliance Priority Setting Partnership

    PubMed Central

    Layton, Alison; Eady, E Anne; Peat, Maggie; Whitehouse, Heather; Levell, Nick; Ridd, Matthew; Cowdell, Fiona; Patel, Mahenda; Andrews, Stephen; Oxnard, Christine; Fenton, Mark; Firkins, Lester

    2015-01-01

    Objectives The Acne Priority Setting Partnership (PSP) was set up to identify and rank treatment uncertainties by bringing together people with acne, and professionals providing care within and beyond the National Health Service (NHS). Setting The UK with international participation. Participants Teenagers and adults with acne, parents, partners, nurses, clinicians, pharmacists, private practitioners. Methods Treatment uncertainties were collected via separate online harvesting surveys, embedded within the PSP website, for patients and professionals. A wide variety of approaches were used to promote the surveys to stakeholder groups with a particular emphasis on teenagers and young adults. Survey submissions were collated using keywords and verified as uncertainties by appraising existing evidence. The 30 most popular themes were ranked via weighted scores from an online vote. At a priority setting workshop, patients and professionals discussed the 18 highest-scoring questions from the vote, and reached consensus on the top 10. Results In the harvesting survey, 2310 people, including 652 professionals and 1456 patients (58% aged 24 y or younger), made submissions containing at least one research question. After checking for relevance and rephrasing, a total of 6255 questions were collated into themes. Valid votes ranking the 30 most common themes were obtained from 2807 participants. The top 10 uncertainties prioritised at the workshop were largely focused on management strategies, optimum use of common prescription medications and the role of non-drug based interventions. More female than male patients took part in the harvesting surveys and vote. A wider range of uncertainties were provided by patients compared to professionals. Conclusions Engaging teenagers and young adults in priority setting is achievable using a variety of promotional methods. The top 10 uncertainties reveal an extensive knowledge gap about widely used interventions and the relative merits

  12. Hand-Held Instrument Fights Acne, Tops Over-the-Counter Market

    NASA Technical Reports Server (NTRS)

    2007-01-01

    Tyrell Inc., a Houston-based medical technologies company, was able to access engineering support in redesigning a heating element for a hand-held acne-fighting device through SATOP, NASA's Space Alliance Technology Outreach Program. SATOP put Tyrell in contact with The Boeing Company, which assessed the design and made several major contributions. The product, named Zeno, is now the highest selling over-the-counter medical device for the treatment of acne, and in 2006, Zeno was named the "SATOP Texas, Success Story of the Year." Zeno employs proprietary ClearPoint technology to provide relief of mild to moderate inflammatory acne by delivering a precisely controlled low-level dosage of heat to the blemish, causing the bacteria at the root of more than 90 percent of acne to self-destruct. Within its first year on the market, Zeno was cited by various publications for several awards, including Allure's 2005 "Best of Beauty," Marie Claire's "10 Best Gadgets for Girls," and Popular Science's 2005 "Best of What's New." A variation of the Zeno for use in treating herpetic lesions such as cold sores, by killing the virus that causes them, is currently undergoing FDA trials.

  13. Acne: risk indicator for increased body mass index and insulin resistance.

    PubMed

    Melnik, Bodo C; John, Swen Malte; Plewig, Gerd

    2013-11-01

    Acne appears to represent a visible indicator disease of over-activated mTORC1 signalling, an unfavour-able metabolic deviation on the road to serious common Western diseases of civilisation associated with increased body mass index and insulin resistance. Exaggerated mTORC1 signalling by Western diet explains the association of acne with increased body mass index, insulin resistance, and early onset of menarche. Both, a high glycaemic load and increased consumption of milk and milk products, staples of Western diet, aggravate mammalian target of rapamycin complex 1 signalling. This review of the literature summarises present evidence for an association between acne, increased body mass index, insulin resistance and Western diet. By dietary intervention with a Palaeolithic-type diet, the dermatologist has the chance to attenuate patients' increased mTORC1 signalling by reducing glycaemic load and milk consumption, which may not only improve acne but may delay the march to more serious mTORC1-driven diseases of civilisation. PMID:23975508

  14. Treating acne with oral contraceptives: use of lower doses.

    PubMed

    Huber, Johannes; Walch, Katharina

    2006-01-01

    Oral contraceptives (OCs) have been shown to effectively treat acne. Clinical trials of various doses of ethinyl estradiol (EE) combined with progestins such as levonorgestrel, desogestrel, norgestimate, gestodene, cyproterone acetate and drospirenone in monophasic, triphasic and combiphasic formulations used to treat acne in women are reviewed here. Open-label and comparative studies beginning in the 1980s were the first to demonstrate objective and subjective reductions in the incidence of acne, severity of existing acne and seborrhea. Placebo-controlled trials have corroborated these findings with a trend toward effective acne treatment with declining doses of EE. Significant reductions in total, inflammatory and noninflammatory lesions compared with placebo have been demonstrated with an OC containing the low dose of 20 microg of EE. Collectively, these findings support the use of low-dose OCs for the treatment of acne. PMID:16371290

  15. Formulation and evaluation of herbal anti-acne moisturizer.

    PubMed

    Rasheed, Arun; Shama, Shaik Neelufar; Joy, Jyothi Mulanjananiyil; Reddy, Bobbu Sravya; Roja, Chirra

    2012-10-01

    The moisture content present in human skin makes it look young and the use of moisturizer results in fastening the moisture with a surface film of oil. Acne vulgaris is one of the most commonly seen diseases among the youth. The present study is focused on the use of herbs as moisturizer for acne treatment. The anti-acne moisturizer was formulated from herbal crude extracts and investigated the physico-chemical parameters as well as antibacterial activity of the formulation. The study revealed that ethanol extract of Andrographis paniculata, Glycyrrhiza glabra, Ocimum sanctum, Azadiracta indica and Green tea possessed the potential for inhibiting acne. It was observed that the optimal formula of anti-acne moisturizer was satisfactorily effective to control acne inducing bacteria i.e., Staphylococcus epidermis and Propionibacterium. The physico-chemical parameters of the formulation were also optimal with no signs of irritation. PMID:23010007

  16. A global perspective on the epidemiology of acne.

    PubMed

    Tan, J K L; Bhate, K

    2015-07-01

    Acne is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide. Epidemiological studies have demonstrated that acne is most common in postpubescent teens, with boys most frequently affected, particularly with more severe forms of the disease. This paper aims to provide an update on the epidemiology of acne worldwide. Recent general and institutional studies from around the world have shown that the prevalence of acne is broadly consistent globally (with the exception of specific populations, which are discussed). However, this review highlights that there is a wide range of disparate outcome measures being applied in epidemiology studies, and we emphasize the need to develop a widely accepted, credible, standard assessment scale to address this in the future. In addition we discuss special populations, such as those devoid of acne, as well as the impact of potential determinants of acne on disease epidemiology. PMID:25597339

  17. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This guidance outlines FDA's current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of......

  18. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  19. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  20. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  1. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  2. 37 CFR 1.778 - Calculation of patent term extension for an animal drug product.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... period for an animal drug will be determined by the Secretary of Health and Human Services. Under 35 U.S... extension for an animal drug product. 1.778 Section 1.778 Patents, Trademarks, and Copyrights UNITED STATES... patent term extension for an animal drug product. (a) If a determination is made pursuant to § 1.750...

  3. 78 FR 27405 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory...

  4. 78 FR 29142 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee... be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory...

  5. 21 CFR 330.3 - Imprinting of solid oral dosage form drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Imprinting of solid oral dosage form drug products... AS SAFE AND EFFECTIVE AND NOT MISBRANDED General Provisions § 330.3 Imprinting of solid oral dosage form drug products. A requirement to imprint an identification code on solid oral dosage form...

  6. 21 CFR 330.3 - Imprinting of solid oral dosage form drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Imprinting of solid oral dosage form drug products... AS SAFE AND EFFECTIVE AND NOT MISBRANDED General Provisions § 330.3 Imprinting of solid oral dosage form drug products. A requirement to imprint an identification code on solid oral dosage form...

  7. 21 CFR 330.3 - Imprinting of solid oral dosage form drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Imprinting of solid oral dosage form drug products... AS SAFE AND EFFECTIVE AND NOT MISBRANDED General Provisions § 330.3 Imprinting of solid oral dosage form drug products. A requirement to imprint an identification code on solid oral dosage form...

  8. 21 CFR 330.3 - Imprinting of solid oral dosage form drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Imprinting of solid oral dosage form drug products... AS SAFE AND EFFECTIVE AND NOT MISBRANDED General Provisions § 330.3 Imprinting of solid oral dosage form drug products. A requirement to imprint an identification code on solid oral dosage form...

  9. 21 CFR 330.3 - Imprinting of solid oral dosage form drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Imprinting of solid oral dosage form drug products... AS SAFE AND EFFECTIVE AND NOT MISBRANDED General Provisions § 330.3 Imprinting of solid oral dosage form drug products. A requirement to imprint an identification code on solid oral dosage form...

  10. 78 FR 17933 - Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ...) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness...) has determined that the three drug products listed in this document were not withdrawn from ] sale for... or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons...

  11. Prediction of in vivo drug performance using in vitro dissolution coupled with STELLA: a study with selected drug products.

    PubMed

    Chakraborty, Sumon; Yadav, Lokesh; Aggarwal, Deepika

    2015-01-01

    Prediction of the in vivo performance of the drug product from the in vitro studies is the major challenging job for the pharmaceutical industries. From the current regulatory perspective, biorelevant dissolution media should now be considered as quality control media in order to avoid the risk associated. Physiological based pharmacokinetic models (PBPK) coupled with biorelevant dissolution medium is widely used in simulation and prediction of the plasma drug concentration and in vivo drug performance. The present investigation deals with the evaluation of biorelevant dissolution media as well as in vivo drug performance by PBPK modelling using STELLA® simulation software. The PBPK model was developed using STELLA® using dissolution kinetics, solubility, standard gastrointestinal parameters and post-absorptive disposition parameters. The drug product selected for the present study includes Linezolid film-coated immediate-release tablets (Zyvox), Tacrolimus prolonged-release capsules (Advagraf), Valganciclovir tablets (Valcyte) and Mesalamine controlled-release capsules (Pentasa) each belonging to different biopharmaceutics classification system (BCS). The simulated plasma drug concentration was analyzed and pharmacokinetic parameters were calculated and compared with the reported values. The result from the present investigation indicates that STELLA® when coupled with biorelevant dissolution media can predict the in vivo performance of the drug product with prediction error less than 20% irrespective of the dosage form (immediate release versus modified release) and BCS Classification. Thus, STELLA® can be used for in vivo drug prediction which will be helpful in generic drug development. PMID:25494535

  12. A Honey Trap for the Treatment of Acne: Manipulating the Follicular Microenvironment to Control Propionibacterium acnes

    PubMed Central

    Eady, E. Anne; Layton, Alison M.; Cove, Jonathan H.

    2013-01-01

    Today, as 40 years ago, we still rely on a limited number of antibiotics and benzoyl peroxide to treat inflammatory acne. An alternative way of suppressing the growth of Propionibacterium acnes is to target the environment in which it thrives. We conjecture that P. acnes colonises a relatively “extreme” habitat especially in relation to the availability of water and possibly related factors such as ionic strength and osmolarity. We hypothesise that the limiting “nutrient” within pilosebaceous follicles is water since native sebum as secreted by the sebaceous gland contains none. An aqueous component must be available within colonised follicles, and water may be a major factor determining which follicles can sustain microbial populations. One way of preventing microbial growth is to reduce the water activity (aw) of this component with a biocompatible solute of very high water solubility. For the method to work effectively, the solute must be small, easily diffusible, and minimally soluble in sebaceous lipids. Xylose and sucrose, which fulfil these criteria, are nonfermentable by P. acnes and have been used to reduce water activity and hence bacterial colonisation of wounds. A new follicularly targeted topical treatment for acne based on this approach should be well tolerated and highly effective. PMID:23762853

  13. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug... Moines, IA 50322. BANMINTH Premix (pyrantel tartrate). Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin... Five NADAs by Truow Nutrition, Inc. NADA No. product 21 CFR section affected (sponsor drug...

  14. Identification of antimycotic drugs transformation products upon UV exposure.

    PubMed

    Casado, Jorge; Rodríguez, Isaac; Ramil, María; Cela, Rafael

    2015-05-30

    The reactivity of three imidazolic, environmental persistent antimycotic drugs (clotrimazole, CTZ; ketoconazole, KTZ; and miconazole, MCZ) upon exposure to ultraviolet (UV) radiation is discussed. First, precursor compounds were immobilized in a silicone support which was further exposed to UV light at two different wavelengths: 254 and 365 nm. After solvent desorption, degradation kinetics of the precursor pharmaceuticals, identification of the arising transformation products (TPs) and evaluation of their time-course were investigated by liquid chromatography (LC) with quadrupole time-of-flight (QTOF) mass spectrometry (MS) detection. The three antimycotics displayed similar stabilities when exposed to 254 nm light; however, CTZ was significantly more stable than MCZ and KTZ when irradiated with the 365 nm lamp. TPs identified in silicone supports resulted from de-chlorination, cleavage, intra-molecular cyclization and hydroxylation reactions. Many of these species were also detected when exposing other solid matrices, such as sand and agricultural soil, previously spiked with target compounds, to UV light. The 50% estimated lethal concentration, calculated using the 48-h Daphnia magna test, for the two main TPs of CTZ and MCZ, at both wavelengths, were lower than those corresponding to the precursor drugs. PMID:25710817

  15. Etiopathogenesis and Therapeutic Approach to Adult Onset Acne

    PubMed Central

    Kaur, Sarabjit; Verma, Poonam; Sangwan, Ankita; Dayal, Surabhi; Jain, Vijay Kumar

    2016-01-01

    Acne vulgaris is usually considered as a skin disorder that primarily affects adolescents reaching a peak at the age of 14–17 years in females and 16–19 years in males. However, recent epidemiologic studies have shown that a significant number of female patients aged >25 years experience acne. As it is regarded as a disease of teenagers, adults are more apprehensive and experience social anxiety. Hence, adult onset acne has become a matter of concern. PMID:27512185

  16. In vitro LED and laser light photoinactivation of Propionibacterium acnes

    NASA Astrophysics Data System (ADS)

    Tuchina, Elena S.; Tuchin, Valery V.

    2008-06-01

    Acne is a genetic, hormonal disease characterized by overproduction of oil by the sebaceous glands, plugging of the sebaceous glands to form micro- and macro- comedons and, finally, action of skin bacteria on oil trapped underneath the skin to red inflammatory cystic lesions. It was shown, that Propionibacterium acnes, the bacteria responsible for acne, was rather subjected to action of red and infrared radiation. The effect of the given radiation amplified at this bacteria by various solutions of photosensitizes.

  17. Etiopathogenesis and Therapeutic Approach to Adult Onset Acne.

    PubMed

    Kaur, Sarabjit; Verma, Poonam; Sangwan, Ankita; Dayal, Surabhi; Jain, Vijay Kumar

    2016-01-01

    Acne vulgaris is usually considered as a skin disorder that primarily affects adolescents reaching a peak at the age of 14-17 years in females and 16-19 years in males. However, recent epidemiologic studies have shown that a significant number of female patients aged >25 years experience acne. As it is regarded as a disease of teenagers, adults are more apprehensive and experience social anxiety. Hence, adult onset acne has become a matter of concern. PMID:27512185

  18. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  19. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  20. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  1. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  2. 21 CFR 201.56 - Requirements on content and format of labeling for human prescription drug and biological products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Requirements on content and format of labeling for human prescription drug and biological products. 201.56 Section 201.56 Food and Drugs FOOD AND DRUG... human prescription drug and biological products. (a) General requirements. Prescription drug...

  3. The use of hormonal agents in the treatment of acne.

    PubMed

    Hassoun, Lauren A; Chahal, Dev S; Sivamani, Raja K; Larsen, Larissa N

    2016-06-01

    Hormones and androgens play an important role in the pathogenesis of acne. Multiple hormonal modulators are now available for the treatment of acne. The efficacies and side effects of currently available hormonal agents are reviewed here including the use of oral contraceptives, spironolactone, flutamide, cyproterone acetate, finasteride, and cortexolone 17α-propionate. Hormonal therapies are an efficacious treatment option for acne among females. With the growing need to reduce antibiotic exposures, hormonal therapies should be more widely studied and incorporated into acne treatment strategies. PMID:27416311

  4. Repair of acne scars with Dermicol-P35.

    PubMed

    Smith, Kevin C

    2009-01-01

    Acne vulgaris is a prevalent skin condition that can cause disfiguring residual scarring. While the complete removal of acne scars is unlikely, several treatments exist that can improve the appearance of acne scars. Dermal fillers offer a simple, nonsurgical corrective procedure that can provide improved skin texture. Dermicol-P35 (Evolence [Ortho Dermatologics, Skillman, NJ]) is a new, highly purified, ribose cross-linked, porcine collagen-based dermal filler that has demonstrated low immunogenicity and results that persist for at least 12 months. This article presents the aesthetic results of a male patient treated with Dermicol-P35 for severe facial acne scars. PMID:19577176

  5. Use of lipidomics to investigate sebum dysfunction in juvenile acne.

    PubMed

    Camera, Emanuela; Ludovici, Matteo; Tortorella, Sara; Sinagra, Jo-Linda; Capitanio, Bruno; Goracci, Laura; Picardo, Mauro

    2016-06-01

    Acne is a multifactorial skin disorder frequently observed during adolescence with different grades of severity. Multiple factors centering on sebum secretion are implicated in acne pathogenesis. Despite the recognized role of sebum, its compositional complexity and limited analytical approaches have hampered investigation of alterations specifically associated with acne. To examine the profiles of lipid distribution in acne sebum, 61 adolescents (29 males and 32 females) were enrolled in this study. Seventeen subjects presented no apparent clinical signs of acne. The 44 affected individuals were clinically classified as mild (13 individuals), moderate (19 individuals), and severe (12 individuals) acne. Sebum was sampled from the forehead with Sebutape(TM) adhesive patches. Profiles of neutral lipids were acquired with rapid-resolution reversed-phase/HPLC-TOF/MS in positive ion mode. Univariate and multivariate statistical analyses led to the identification of lipid species with significantly different levels between healthy and acne sebum. The majority of differentiating lipid species were diacylglycerols (DGs), followed by fatty acyls, sterols, and prenols. Overall, the data indicated an association between the clinical grading of acne and sebaceous lipid fingerprints and highlighted DGs as more abundant in sebum from adolescents affected with acne. PMID:27127078

  6. Physical Modalities (Devices) in the Management of Acne.

    PubMed

    Nestor, Mark S; Swenson, Nicole; Macri, Angela

    2016-04-01

    Treatment options for acne vulgaris are enhanced by laser and light therapy. Both visible and laser light are effective treatments for acne. Visible light and many lasers target Propionibacterium acnes porphyrins while others act as anti-inflammatory mediators or reduce sebaceous gland activity. Compared with topical and systemic therapies, laser and light therapies have few if any side effects and appear to be safe during pregnancy. If patients prefer at home light treatments, several devices are currently available and have been shown to have efficacy. Ultimately, combining laser and light with topical therapy may well become the mainstay of acne treatment. PMID:27015782

  7. Acne is not associated with yet-uncultured bacteria.

    PubMed

    Bek-Thomsen, M; Lomholt, H B; Kilian, M

    2008-10-01

    Current clinical and microbiological information on acne fails to demonstrate a clear association between particular species, including Propionibacterium acnes, and disease, and the disease continues to be a considerable problem. To test if acne is associated with hitherto uncultured bacteria residing in diseased skin follicles, sequencing and phylogenetic analysis of approximately 5,700 amplified and cloned 16S rRNA genes were used to determine the microbial diversity in follicles from acne patients and healthy individuals and from the superficial skin of acne patients. Follicles from healthy skin were exclusively colonized by P. acnes, whereas the follicular microbiota of acne patients included, in addition, Staphylococcus epidermidis and minor proportions of other species. In comparison, samples from superficial skin showed a complex microbiota represented by 12 to 16 bacterial species. The findings of the study exclude the possibility that acne is associated with yet-uncultured bacteria and shows that healthy skin follicles constitute a remarkably exclusive habitat allowing colonization only by P. acnes. PMID:18716234

  8. Role of insulin resistance and diet in acne.

    PubMed

    Kumari, Rashmi; Thappa, Devinder Mohan

    2013-01-01

    There is increasing evidence in support of the interplay of growth hormone (GH), insulin, and insulin-like growth factor-1 (IGF-1) signaling during puberty, which have a causal role in pathogenesis of acne by influencing adrenal and gonadal androgen metabolism. Milk consumption and hyperglycemic diets can induce insulin and IGF-1-mediated PI3K ⁄ Akt-activation inducing sebaceous lipogenesis, sebocyte, and keratinocyte proliferation, which can aggravate acne. Occurence of acne as part of various syndromes also provides evidence in favor of correlation between IGF-1 and acne. PMID:23619434

  9. Diet and acne update: carbohydrates emerge as the main culprit.

    PubMed

    Mahmood, Shereen N; Bowe, Whitney P

    2014-04-01

    The prevalence of adult acne in the US appears to be increasing over the last few decades. But what's behind the rise: is it nature or nurture? We are well aware that genetics can strongly influence a patient's risk of developing acne. However, significant changes in germline genetic variants are unlikely to have occurred over the last 20 years. Consequently, we are forced to examine environmental variables, including diet. This review article presents the most updated evidence supporting a link between refined carbohydrates and acne. Based on the data summarized here, dermatologists should encourage their acne patients to minimize their intake of high glycemic index foods. PMID:24719062

  10. Comorbidities of hidradenitis suppurativa (acne inversa)

    PubMed Central

    Fimmel, Sabine

    2010-01-01

    Comorbidities of hidradenitis suppurativa (acne inversa) were reviewed by extracting original and review publications included in MEDLINE, EMBASE and COCHRANE libraries using the terms “hidradenitis,” “Verneuil” and “acne inversa.” Follicular occlusion disorders, inflammatory bowel diseases, especially Crohn disease, spondylarthropathy, other hyperergic diseases, genetic keratin disorders associated with follicular occlusion and squamous cell carcinoma were the most common hidradenitis suppurativa comorbid diseases. A first classification of these major comorbidities and their possible genetic background reveals a list of chromosome loci and genes, which could be hidradenitis suppurativa candidates. Most of these diseases belong to the group of autoinflammatory disorders, where th17 cell cytokines seem to play a central role. PMID:21547142

  11. Acne inversa: difficulties in diagnostics and therapy

    PubMed Central

    Hadasik, Karolina; Brzezińska-Wcisło, Ligia

    2015-01-01

    Acne inversa (hidradenitis suppurativa) is a potentially severe and chronic inflammatory disease with a significant negative influence on the quality of life. Usually, lesions are located in the areas of skin folds and it is characterized by the presence of painful nodules and fistulas with a tendency to tissue fibrosis. Currently, it is suggested that follicular occlusion by infundibular hyperkeratosis plays a crucial role in pathogenesis and an occupation of apocrine sweat glands is a secondary phenomenon. Most often, it refers to men after puberty. This article tries to present the latest theory concerning the etiology of inverted acne and methods of its treatment. It also describes the most common errors in diagnostic and therapeutic procedures, which are mainly connected with repeated and long antibiotic therapy and not radical surgical treatment. PMID:26366155

  12. Spironolactone for 
Adult Female Acne.

    PubMed

    Friedman, Adam J

    2015-10-01

    Many cases of acne are hormonal in nature, meaning that 
they occur in adolescent girls and women and are aggravated 
by hormonal fluctuations such as those that occur during the menstrual cycle or in the setting of underlying hormonal imbalances as seen in polycystic ovary syndrome. For these patients, antihormonal therapy such as spironolactone is a valid and efficacious option. Herein, initiation and utilization of this medication is reviewed. PMID:27141564

  13. A Family Physician's Approach to Acne

    PubMed Central

    Turgeon, Eugene

    1981-01-01

    Because of the potential for permanent physical and psychological sequelae, acne vulgaris should be regarded as a true disease—not the “normal” physiologic response one might infer from its near universal prevalence in adolescence. Effective therapy reduces pilosebaceous unit obstruction, minimizes secondary inflammation, and lessens the chance of significant scarring. This article reviews current therapeutic modalities, and suggests a sequence for implementation of specific agents. ImagesFig. 1Fig. 2Fig. 3Fig. 4Fig. 5 PMID:21289790

  14. Acne - Multiple Languages: MedlinePlus

    MedlinePlus

    ... this page, please enable JavaScript. Chinese - Traditional (繁體中文) Korean (한국어) Spanish (español) Vietnamese (Tiếng Việt) Chinese - Traditional ( ... Institute of Arthritis and Musculoskeletal and Skin Diseases Korean (한국어) What Is Acne? English 여드름이란 무엇인가? - 한국어 ( ...

  15. 21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... What controls and acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for...

  16. 21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... control the distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped...

  17. 21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality,...

  18. 21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET...

  19. 21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET...

  20. 21 CFR 212.90 - What actions must I take to control the distribution of PET drug products?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... distribution of PET drug products? 212.90 Section 212.90 Food and Drugs FOOD AND DRUG ADMINISTRATION... distribution of PET drug products? (a) Written distribution procedures. You must establish, maintain, and follow written procedures for the control of distribution of PET drug products shipped from the PET...