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Sample records for acne drug products

  1. 21 CFR 333.350 - Labeling of acne 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 acne drug products. 333.350 Section... Acne Drug Products § 333.350 Labeling of acne 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...

  2. 21 CFR 333.350 - Labeling of acne 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 acne drug products. 333.350 Section... Acne Drug Products § 333.350 Labeling of acne 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...

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

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

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

  6. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 333 Guidance for Industry on Topical Acne Drug... availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the... ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling...

  7. [Drug therapy of acne].

    PubMed

    Ochsendorf, F R; Degitz, K

    2008-07-01

    Acne is treated according to the clinical picture and the pathophysiologically relevant mechanisms, such as seborrhea, follicular hyperkeratosis, P. acnes colonisation,and inflammation. In mild forms of acne, topical therapy is most appropriate. Comedonal acne can be treated with topical retinoids; papulopustular acne with a combination of retinoids and topical antimicrobial substances (benzoyl peroxide, antibiotics, or azelaic acid). Moderate forms or those with extrafacial involvement can be treated with oral antibiotics combined with topical retinoids or benzoyl peroxide. Acne conglobata and other severe manifestations are treated with oral isotretinoin. Women are also treated with oral contraceptives containing anti-androgenic progestins. If inflammation is prominent, initial short term treatment with oral glucocorticoids is helpful. Second-line agents include oral zinc or dapsone. Following successful treatment, topical retinoids are suitable for maintenance therapy.

  8. Emerging drugs for acne.

    PubMed

    James, Kirk A; Burkhart, Craig N; Morrell, Dean S

    2009-12-01

    Acne vulgaris is a common skin disorder that affects most individuals at some point in their lives. It may result in significant morbidity, including cutaneous scarring and psychological impairment. Current treatments include topical retinoids, benzoyl peroxide, topical and systemic antibiotics, and systemic isotretinoin. There are growing concerns of rising antibiotic resistance, significant side effects of isotretinoin therapy, and lack of safe and effective treatment for pregnant females. Recent advances in the pathogenesis of acne have led to a greater understanding of the underlying inflammatory mechanisms and the role the Propionibacterium acnes and biofilms. This has led to the development of new therapeutic targets. This article reviews emerging treatments of acne, including topical picolinic acid, topical antibiotic dapsone, systemic zinc salts, oral antibiotic lymecycline, new formulations of and synergistic combinations of benzoyl peroxide, photodynamic therapy with topical photosensitizers and potential acne vaccines.

  9. 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

    2010-03-04

    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 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.

  10. 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 ...

  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. Acne

    MedlinePlus

    ... Schedules Nutrient Shortfall Questionnaire Home Diseases and Conditions Acne Acne Condition Family HealthKids and Teens Share Acne Table of Contents1. Overview2. Causes3. Treatment4. Complications5. Questions ...

  13. 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 ...

  14. 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

  15. 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.

  16. Acne

    MedlinePlus

    ... peroxide (say: BEN-zoil peh - ROK - side) or salicylic (say: sal-uh-SIL - ick) acid in them ... it also can reduce swelling (puffiness) of pimples. Salicylic acid is another acne-fighting ingredient. It causes ...

  17. Acne

    MedlinePlus

    ... with your doctor about your treatment plan. Can birth control pills help treat acne? For women who break out mainly around their menstrual cycle, some birth control pills can help. Research shows that these pills ...

  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

    Whiting, D A

    1979-12-01

    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 17beta-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.

  20. 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

  1. [Acne and hormones].

    PubMed

    Faure, Michel

    2002-04-15

    Androgens stimulate sebum production which is necessary for the development of acne. Acne in women may thus be considered as a manifestation of cutaneous androgenization. Most of acnes may be related to an idiopathic skin hyperandrogenism due to in situ enzyme activity and androgen receptor hypersensitivity, as also noted in idiopathic hirsutism. Some acne may correspond to elevated ovarian or adrenal androgen secretion. The presence of acne in women may lead to a diagnosis of functional hyperandrogenism, either polycysticovary syndrome or nonclassical 21-hydroxylase deficiency. Plasma level assays for testosterone, delta 4 androstenedione and 17-OH progesterone and ovarian echography are necessary to determine the possibility for an ovarian or adrenal hyperandrogenism, but not to better treat acne. The goal of hormonal therapy in acne is to oppose the effects of androgens on the sebaceous gland. Hormones may be used in female acne in the absence of endocrine abnormalities. Antiandrogens (cyproterone acetate or aldactone) may be useful in severe acne, hormonal contraceptives with cyproterone acetate or non androgenic progestins in mild or common acne often in association with other anti-acneic drugs. Glucocorticoids have to be administered in acne fulminans and other forms of acute, severe, inflammatory acne, for their anti-inflammatory properties.

  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, 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...

  4. 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...

  5. 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...

  6. 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...

  7. [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.

  8. Acne vulgaris.

    PubMed

    Wilson, B B

    1989-09-01

    Acne vulgaris is a disease of the pilosebaceous unit that affects nearly all persons to some degree during the teenage years. It is a disease that should be treated because of the anxiety and disfigurement it causes in the affected patient. Acne therapy is directed against the three probable pathogenic processes in acne: (1) abnormal keratinization of the sebaceous follicle, (2) excessive production of sebum, and (3) proliferation of bacteria in the follicle. Superficial acne consisting of comedones and small papulopustules will frequently respond to topical therapy such as retinoic acid, benzoyl peroxide, and topical antibiotics. Deeper lesions require systemic antibiotics of which tetracycline is the drug of choice. Severe, recalcitrant cystic acne usually responds well to the oral retinoid, isotretinoin. The severe teratogenic effects of isotretinoin on a developing fetus make this a risky drug to prescribe for women with childbearing potential. In such cases the greatest precautions should be taken to avoid pregnancy during a course of isotretinoin. Such precautions include pregnancy testing, contraceptive counseling, and the use of at least two effective forms of birth control in sexually active women.

  9. Hormone therapy in acne.

    PubMed

    Lakshmi, Chembolli

    2013-01-01

    Underlying hormone imbalances may render acne unresponsive to conventional therapy. Relevant investigations followed by initiation of hormonal therapy in combination with regular anti-acne therapy may be necessary if signs of hyperandrogenism are present. In addition to other factors, androgen-stimulated sebum production plays an important role in the pathophysiology of acne in women. Sebum production is also regulated by other hormones, including estrogens, growth hormone, insulin, insulin-like growth factor-1, glucocorticoids, adrenocorticotropic hormone, and melanocortins. Hormonal therapy may also be beneficial in female acne patients with normal serum androgen levels. An understanding of the sebaceous gland and the hormonal influences in the pathogenesis of acne would be essential for optimizing hormonal therapy. Sebocytes form the sebaceous gland. Human sebocytes express a multitude of receptors, including receptors for peptide hormones, neurotransmitters and the receptors for steroid and thyroid hormones. Various hormones and mediators acting through the sebocyte receptors play a role in the orchestration of pathogenetic lesions of acne. Thus, the goal of hormonal treatment is a reduction in sebum production. This review shall focus on hormonal influences in the elicitation of acne via the sebocyte receptors, pathways of cutaneous androgen metabolism, various clinical scenarios and syndromes associated with acne, and the available therapeutic armamentarium of hormones and drugs having hormone-like actions in the treatment of acne.

  10. Acne Scars

    MedlinePlus

    ... How to Choose the Best Skin Care Products Acne Scars Treatment Options Learn more about treatment options ... and flawless as the original skin. Why treat acne scarring Physical, emotional and social reasons for treating ...

  11. Characterizing the relationship between free drug samples and prescription patterns for acne vulgaris and rosacea

    PubMed Central

    Hurley, Michael P.; Stafford, Randall S.; Lane, Alfred T.

    2014-01-01

    Importance Describing the relationship between the availability of free prescription drug samples and dermatologists’ prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician’s office. Objective To investigate the relationships between free drug samples and dermatologists’ local and national prescribing patterns and between the availability of free drug samples and prescription costs. Design, Setting, and Participants Cross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of a nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of either acne vulgaris or acne rosacea in 2010. Main Outcome Measures National trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples. Results On a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase directly correlates with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs

  12. Green Tea and Other Tea Polyphenols: Effects on Sebum Production and Acne Vulgaris

    PubMed Central

    Saric, Suzana; Notay, Manisha; Sivamani, Raja K.

    2016-01-01

    Polyphenols are antioxidant molecules found in many foods including nuts, fruits, vegetables, chocolate, wine, and tea. Polyphenols have antimicrobial, anti-inflammatory, and antineoplastic properties. Recent studies suggest that tea polyphenols may be used for reducing sebum production in the skin and for treatment of acne vulgaris. This review examines the evidence for use of topically and orally ingested tea polyphenols against sebum production and for acne treatment and prevention. The PubMed database was searched for studies on tea polyphenols, sebum secretion, and acne vulgaris. Of the 59 studies found, eight met the inclusion criteria. Two studies evaluated tea polyphenol effects on sebum production; six studies examined tea polyphenol effects on acne vulgaris. Seven studies evaluated topical tea polyphenols; one study examined systemic tea polyphenols. None of the studies evaluated both topical and systemic tea polyphenols. Tea polyphenol sources included green tea (six studies) and tea, type not specified (two studies). Overall, there is some evidence that tea polyphenols in topical formulation may be beneficial in reducing sebum secretion and in treatment of acne. Research studies of high quality and with large sample sizes are needed to assess the efficacy of tea polyphenols in topical and oral prevention of acne vulgaris and lipid synthesis by the sebaceous glands. PMID:28036057

  13. Green Tea and Other Tea Polyphenols: Effects on Sebum Production and Acne Vulgaris.

    PubMed

    Saric, Suzana; Notay, Manisha; Sivamani, Raja K

    2016-12-29

    Polyphenols are antioxidant molecules found in many foods including nuts, fruits, vegetables, chocolate, wine, and tea. Polyphenols have antimicrobial, anti-inflammatory, and antineoplastic properties. Recent studies suggest that tea polyphenols may be used for reducing sebum production in the skin and for treatment of acne vulgaris. This review examines the evidence for use of topically and orally ingested tea polyphenols against sebum production and for acne treatment and prevention. The PubMed database was searched for studies on tea polyphenols, sebum secretion, and acne vulgaris. Of the 59 studies found, eight met the inclusion criteria. Two studies evaluated tea polyphenol effects on sebum production; six studies examined tea polyphenol effects on acne vulgaris. Seven studies evaluated topical tea polyphenols; one study examined systemic tea polyphenols. None of the studies evaluated both topical and systemic tea polyphenols. Tea polyphenol sources included green tea (six studies) and tea, type not specified (two studies). Overall, there is some evidence that tea polyphenols in topical formulation may be beneficial in reducing sebum secretion and in treatment of acne. Research studies of high quality and with large sample sizes are needed to assess the efficacy of tea polyphenols in topical and oral prevention of acne vulgaris and lipid synthesis by the sebaceous glands.

  14. Treatment of acne with tea tree oil (melaleuca) products: a review of efficacy, tolerability and potential modes of action.

    PubMed

    Hammer, K A

    2015-02-01

    Over-the-counter acne treatments containing tea tree oil from the plant Melaleuca alternifolia are widely available, and evidence indicates that they are a common choice amongst those self-treating their acne. The aims of this review were to collate and evaluate the clinical evidence on the use of tea tree oil products for treating acne, to review safety and tolerability and to discuss the underlying modes of therapeutic action.

  15. 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

  16. 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

    2015-03-28

    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.

  17. Rhodomyrtone inhibits lipase production, biofilm formation, and disorganizes established biofilm in Propionibacterium acnes.

    PubMed

    Wunnoo, Suttiwan; Saising, Jongkon; Voravuthikunchai, Supayang Piyawan

    2017-02-01

    Virulence enzymes and biofilm a play crucial role in the pathogenesis of Propionibacterium acnes, a major causative agent of acne vulgaris. In the present study, the effects of rhodomyrtone, a pure compound identified from Rhodomyrtus tomentosa (Aiton) Hassk. leaves extract against enzyme production and biofilm formation production by 5 clinical isolates and a reference strain were evaluated. The degree of hydrolysis by both lipase and protease enzymes significantly decreased upon treatment with the compound at 0.125-0.25 μg/mL (p < 0.05). Lipolytic zones significantly reduced in all isolates while decrease in proteolytic activities was found only in 50% of the isolates. Rhodomyrtone at 1/16MIC and 1/8MIC caused significant reduction in biofilm formation of the clinical isolates (p < 0.05). Percentage viability of P. acnes within mature biofilm upon treated with the compound at 4MIC and 8MIC ranged between 40% and 85%. Pronounced properties of rhodomyrtone suggest a path towards developing a novel anti-acne agent.

  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).

  19. Flavones Isolated from Scutellariae radix Suppress Propionibacterium Acnes-Induced Cytokine Production In Vitro and In Vivo.

    PubMed

    Tsai, Po-Jung; Huang, Wen-Cheng; Hsieh, Ming-Chi; Sung, Ping-Jyun; Kuo, Yueh-Hsiung; Wu, Wen-Huey

    2015-12-24

    Scutellariae radix, the root of Scutellaria baicalensis, has long been applied in traditional formulations and modern herbal medications. Propionibacterium acnes (P. acnes) in follicles can trigger inflammation and lead to the symptom of inflammatory acnes vulgaris. This study was aimed at evaluating the effect of Scutellariae radix extract and purified components isolated from it on inflammation induced by P. acnes in vitro and in vivo. The results showed the ethyl acetate (EA) soluble fraction from the partition of crude ethanolic extract from Scutellariae radix inhibited P. acnes-induced interleukin IL-8 and IL-1β production in human monocytic THP-1 cells. Seven flavones were isolated from the EA fraction by repeated chromatographies, and identified as 5,7-dihydroxy-6-methoxyflavone (FL1, oroxylin), 5,7-dihydroxy-8-methoxyflavone (FL2, wogonin), 5-hydroxy-7,8-dimethoxyflavone (FL3, 7-O-methylwogonin), 5,6'-dihydroxy-6,7,8,2'-tetramethoxy flavone (FL4, skullcapflavone II), 5,7,4'-trihydroxy-8-methoxyflavone (FL5), 5,2',6'-trihydroxy-7,8-dimethoxyflavone (FL6, viscidulin II), and 5,7,2',5'-tetrahydroxy-8,6'-dimethoxyflavone (FL7, ganhuangenin). They all significantly suppressed P. acnes-induced IL-8 and IL-1β production in THP-1 cells, and FL2 exerted the strongest effect with half maximal inhibition (IC50) values of 8.7 and 4.9 μM, respectively. Concomitant intradermal injection of each of the seven flavones (20 μg) with P. acnes effectively attenuated P. acnes-induced ear swelling, and decreased the production of IL-6 and tumor necrosis factor-α in ear homogenates. Our results suggested that all the seven flavones can be potential therapeutic agents against P. acnes-induced skin inflammation.

  20. Correlation between Propionibacterium acnes biotypes, lipase activity and rash degree in acne patients.

    PubMed

    Higaki, S; Kitagawa, T; Kagoura, M; Morohashi, M; Yamagishi, T

    2000-08-01

    We examined the possible correlation between biotypes of Propionibacterium acnes, lipase activity, and rash degree in acne patients. Among 5 P. acnes biotypes, P. acnes biotype 3 (B3) was the most common, followed by P. acnes biotypes 1, 2 and 4; P. acnes biotype 5 was not found. P. acnes B3 was isolated from more severe skin rashes than those of the other biotypes. Production of propionic acid (PA) and butyric acid (BA) by P. acnes B3 was higher than those by the other P. acnes biotypes. As the rash degree in acne patients was more severe, the production of PA and BA elevated. Although only a few P. acnes strains were examined in the present study, P. acnes B3 had the highest lipase activity and might have the greatest influence on skin rash in acne patients.

  1. Over-the-Counter Acne Products: What Works and Why

    MedlinePlus

    ... pores. OTC benzoyl peroxide products are available in strengths from 2.5 to 10 percent. Possible side ... plugged. OTC salicylic acid products are available in strengths from 0.5 to 5 percent. Possible side ...

  2. [DRUG-INDUCED LUPUS CAUSED BY LONG TERM MINOCYCLINE TREATMENT FOR ACNE VULGARIS].

    PubMed

    Hanai, Shunichiro; Sato, Takeo; Takeda, Koichi; Nagatani, Katsuya; Iwamoto, Masahiro; Minota, Seiji

    2015-09-01

    An 18-year-old Japanese girl had received oral minocycline 200mg daily for treatment of acne vulgaris since 16 years old. She had a fever three months before admission, followed by joint pains in her knees, elbows and several proximal interphalangeal joints one month before admission. She was referred to our hospital because of a high serum level of anti-DNA antibody. She had already discontinued oral minocycline five weeks before admission, because she missed her medication refilled. On admission, the arthralgia and fever spontaneously resolved, and there were no laboratory evidence of hypocomplementemia and cytopenia. She had neither erythema nor internal organ involvements. Because her symptoms subsided spontaneously after the cessation of minocycline, she was considered to have drug-induced lupus. Both the arthralgia and fever did not relapse, and anti-ds DNA antibody returned to normal during a follow-up period without treatment. There are few reports of drug-induced lupus caused by minocycline in Japan. This case highlights the importance of considering minocycline-induced lupus.

  3. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  4. 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

  5. Female acne - a different subtype of teenager acne?

    PubMed

    Preneau, S; Dreno, B

    2012-03-01

    Above all, acne is considered an adolescent affection. However, in literature as in daily life, female acne is becoming more and more common. According to the articles that cover this subject, the prevalence is estimated from 40% to 50%. The objective of our work was to make an overview of new data about female acne at the clinical and epidemiological level to be precise if female acne has to be considered as a subtype of acne different from teenager acne. This review shows that the most frequently recognized age when speaking about female acne is 25 years old. Most commonly it is a light to moderate acne that mainly affects the face. Two clinical forms can be identified: an inflammatory form, the most frequent, made up of papulo-pustules and nodules on the lower part of the face and a retentional form made up of blackheads and micro cysts with hyperseborrhoea. Concerning its evolution, it is characterized by three subtypes of which two are predominant: the most frequent form called 'continue acne' from adolescence to adult age and the less frequent form called 'late onset acne' that starts after 25 years of age. On a physiopathological level two main hypotheses can be proposed. Specific global assessment and therapeutic algorithm would be necessary for female acne, which in addition, in future would have to be considered separately from teenagers for the evaluation of a new drug.

  6. 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.

  7. Acne and Rosacea.

    PubMed

    Picardo, Mauro; Eichenfield, Lawrence F; Tan, Jerry

    2017-01-01

    Acne, one of the most common skin diseases, affects approximately 85% of the adolescent population, and occurs most prominently at skin sites with a high density of sebaceous glands such as the face, back, and chest. Although often considered a disease of teenagers, acne is occurring at an increasingly early age. Rosacea is a chronic facial inflammatory dermatosis characterized by flushing (or transient facial erythema), persistent central facial erythema, inflammatory papules/pustules, and telangiectasia. Both acne and rosacea have a multifactorial pathology that is incompletely understood. Increased sebum production, keratinocyte hyper-proliferation, inflammation, and altered bacterial colonization with Propionibacterium acnes are considered to be the underlying disease mechanisms in acne, while the multifactorial pathology of rosacea is thought to involve both vasoactive and neurocutaneous mechanisms. Several advances have taken place in the past decade in the research field of acne and rosacea, encompassing pathogenesis and epidemiology, as well as the development of new therapeutic interventions. In this article, we provide an overview of current perspectives on the pathogenesis and treatment of acne and rosacea, including a summary of findings from recent landmark pathophysiology studies considered to have important implications for future clinical practice. The advancement of our knowledge of the different pathways and regulatory mechanisms underlying acne and rosacea is thought to lead to further advances in the therapeutic pipeline for both conditions, ultimately providing a greater array of treatments to address gaps in current management practices.

  8. Acne Management

    PubMed Central

    Kushniruk, William

    1973-01-01

    Acne, the most prevalent skin disorder of youth, requires the concomitant management of multiple factors. Clinical and therapeutic aspects of the acne problem are presented. Traditional topical and systemic measures are melded with the current effective antibiotic treatment. A positive informed approach will enable the physician to achieve success with his acne patients. ImagesFigure 1Figure 2 PMID:20468974

  9. Zileuton, a new efficient and safe systemic anti-acne drug

    PubMed Central

    2009-01-01

    Tissue inflammation is a major component of the acne process. Leukotriene B4 (LTB4) is considered to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Since Zileuton blocks the activity of 5-lipoxygenase, experimental and clinical studies have been conducted to test mode of function, as well as efficacy and safety of this compound in the treatment of acne vulgaris. Human SZ95 sebocytes and inflammatory cells in vitro express the enzymes of the leukotriene pathway at mRNA and protein levels and enzymes involved in the biosynthesis of LTB4 are activated in sebaceous glands of acne lesions. Pre-treatment of SZ95 sebocytes with Zileuton partially prevented short-term arachidonic acid-induced effects, such as induction of LTB4, increase of neutral lipid content and stimulation of interlekin-6 release. Long-term treatment with Zileuton directly reduced the content of neutral lipids and interleukin-6 release from SZ95 seb ocytes. PPAR mRNA levels were not regulated by Zileuton. In a first pilot clinical study with 10 patients with papulopustular acne Zileuton 4 × 600 mg/d p.o. for 3 months decreased the acne severity index in a time-dependent manner being 41% of the initial score at week 12 (p < 0.05). This was mostly due to a decrease of the number of inflammatory lesions of 29% (p < 0.01). In addition, total sebum lipids significantly decreased (35%, p < 0.05) and the pro-inflammatory free fatty acids (22%) and lipoperoxides (26%) were markedly diminished in patients’ sebum under treatment. The magnitude of clinical improvement strongly correlated with the reduction of total sebum lipids (p = 0.0009, r2 = 0.81) and free fatty acids (p = 0.0003, r2 = 0.82). In a further study, a 40-year-old female with mild disseminated sebaceous gland hyperplasia and seborrhea, responded with normalization of the casual skin surface lipids and similar reduction of facial sebum synthesis under treatment with

  10. Lipid Mediators in Acne

    PubMed Central

    Ottaviani, Monica; Camera, Emanuela; Picardo, Mauro

    2010-01-01

    Multiple factors are involved in acne pathogenesis, and sebum secretion is one of the main ones. The role sebum plays in acne development has not been completely elucidated yet; however, increasing amounts of data seem to confirm the presence of alterations in sebum from acne patients. Altered ratio between saturated and unsaturated fatty acids has been indicated as an important feature to be considered in addition to the altered amount of specific fatty acids such as linoleic acid. Furthermore, particular attention has been focused on squalene peroxide that seems to be able to induce an inflammatory response beyond cytotoxicity and comedones formation. Moreover, recent data suggest that lipid mediators are able to interfere with sebocytes differentiation and sebogenesis through the activation of pathways related to peroxisome proliferators-activated receptors. Understanding the factors and mechanisms that regulate sebum production is needed in order to identify novel therapeutic strategies for acne treatment. PMID:20871834

  11. Acne: endocrinologic aspects.

    PubMed

    Pochi, P E

    1982-08-01

    Acne is dependent for its development on several factors, one of which is hormonal. The principal and possibly sole mechanistic link between hormones and acne is sebum, the secretory product of the sebaceous glands which is highly androgen-sensitive. Some but not all, patients with acne can be shown to have systemic androgen abnormalities. In addition, there is evidence to suggest that androgens are metabolized abnormally in the skin, possibly resulting in excessive sebaceous gland secretion. Systemic endocrine therapy of acne is designed to reduce the androgenic stimulation of the sebaceous gland. Such treatment includes the peroral cyclic administration of estrogen for ovarian inhibition and the use of low-dosage glucocorticoid for adrenocortical androgen suppression. Combined estrogen-glucocorticoid treatment induces the most telling effect in reducing sebaceous gland activity.

  12. [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.

  13. Historical aspects of the oral use of retinoids in acne.

    PubMed

    Hartmann, D; Bollag, W

    1993-11-01

    A number of investigations of the effects of vitamin A deficiency in animals and man and its treatment with natural products containing vitamin A were carried out in the twenties and thirties. In 1942, a clinical study in patients with acne treated with vitamin A yielded encouraging results. Further trials in the forties and fifties, trying to confirm the beneficial effect of oral vitamin A in acne, met with equivocal success. In the sixties, all-trans retinoic acid (tretinoin) became clinically available, and its topical efficacy in acne could be demonstrated. In 1971, oral tretinoin also was shown to be active in patients with acne. Coincidentally, the efficacy of oral 13-cis retinoic acid (isotretinoin) became evident in a series of unpublished studies in Europe. Then, in 1978, a trial carried out at the NIH, Bethesda, Maryland, yielded convincing evidence that isotretinoin is a potent new drug for the treatment of severe cystic acne. In 1982, isotretinoin was registered in the United States and one year later in Europe for the treatment of severe, recalcitrant, cystic acne. Since then, many thousands of patients suffering psychologically and physically from the severity of their disease have been treated successfully with this drug. However, the main concern of physicians prescribing isotretinoin has to focus on its potentially severe side effects, particularly its teratogenicity.

  14. [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.

  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. Acne vulgaris.

    PubMed

    Robertson, Kevin M

    2004-08-01

    Acne vulgaris is a common inflammatory skin condition that presents management difficulties to cosmetic surgeons. Acute management and treatment focuses on early diagnosis as well as treatment with topical agents, oral antibiotics, hormonal therapy,and nonablative chemical peel and laser applications. The treatment of postinflammatory scarring must be individualized to address potential macular dyschromia, cystic lesions,epithelial bridges, or deep pitted scars. A review of interventional options is presented to apply to the spectrum of acne scarring as well as a review of the literature to address objectively published reports on efficacy.

  17. Acne Surgery

    PubMed Central

    Dilworth, G. R.

    1983-01-01

    Acne surgery consists of comedone extraction of non-inflamed lesions, triamcinolone acetate injections of some inflamed lesions, and extraction of milia. Prevention is a very important part of comedone treatment, especially avoidance of picking, moisturizers and harsh soaps. Instruments are also very important: even the finest may be too thick and may have to be filed down. Acne surgery is only an adjunct of good medical therapy. ImagesFig. 1Fig. 2Fig. 3Fig. 4Fig. 5Fig. 6Fig. 7 PMID:21283373

  18. Cosmetics in acne and rosacea.

    PubMed

    Draelos, Z D

    2001-09-01

    Cosmetics that are appropriate for use in patients with rosacea and acne must be noncomedogenic, nonacnegenic, nonirritating, and hypoallergenic. This requires a basic understanding of cosmetic fromulation and the selection of products that meet guidelines for sensitive skin.

  19. Can I Prevent Acne?

    MedlinePlus

    ... Week of Healthy Breakfasts Shyness Can I Prevent Acne? KidsHealth > For Teens > Can I Prevent Acne? Print ... en español ¿Puedo prevenir el acné? What Causes Acne? Contrary to what you may have heard, acne ...

  20. Can I Prevent Acne?

    MedlinePlus

    ... Week of Healthy Breakfasts Shyness Can I Prevent Acne? KidsHealth > For Teens > Can I Prevent Acne? A ... en español ¿Puedo prevenir el acné? What Causes Acne? Contrary to what you may have heard, acne ...

  1. An alternative pharmacological approach to the detection of anti-androgenic drugs for acne therapy.

    PubMed

    Clanachan, I; Devitt, H; Foreman, M I; Picton, W

    1985-03-01

    Both testosterone and dihydrotestosterone may be able to stimulate sebaceous glands, and the glandular function may continue under direct testosterone control in the presence of 5 alpha-reductase blockade. Antagonism of sebaceous gland hypertrophy, induced by exogenous testosterone or dihydrotestosterone, has been studied in the hairless hamster using established and experimental drugs applied topically. The results support the proposition that testosterone plays a direct role in mediating sebaceous gland response. This suggests possibilities for the design of sebum inhibitory drugs with minimal systemic anti-androgenic side effects.

  2. Can Acne Scars Be Removed?

    MedlinePlus

    ... Surgery? A Week of Healthy Breakfasts Shyness Can Acne Scars Be Removed? KidsHealth > For Teens > Can Acne ... eliminar las cicatrices del acné? Different Types of Acne Scars from acne can seem like double punishment — ...

  3. Acne detergicans.

    PubMed

    Mills, O H; Klingman, A M

    1975-01-01

    Popular brands of soaps and shampoos were assayed for comedogenicity in the rabbit ear. Only a small number produced hyperkeratosis when applied at a 25% concentration. Bacteriostatic substances, especially hexachlorophene, were mildly comedogenic. Conventional soaps include salts of fatty acids; the latter are known comedogens. The obsessive use of soaps by patients with acne vulgaris may aggravate the disease and result in its extension to unusual locations.

  4. 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)

  5. Oral contraceptives in the treatment of acne.

    PubMed

    Tan, J K; Degreef, H

    2001-02-01

    Oral contraceptives (OCs) can reduce acne by lowering the production of adrenal and ovarian androgens, by inhibiting 5-alpha-reductase, which in turn, reduces the levels of dihydrotestosterone, and by stimulating sex hormone binding globulin (SHBG), thus reducing the levels of free testosterone. In newer OCs, such as Tricyclen and Diane-35, the progestin component is minimally androgenic and anti-androgenic respectively, thereby enhancing the favorable profile of these products in the treatment of hyperandrogenic disorders, including acne. The efficacy of these agents and their long-term safety profile supports their use in various grades of acne in females: * As adjunctive therapy to topical agents for women with mild non-scarring acne desiring oral contraception * As primary therapy for patients with moderate non-scarring acne in combination with topical therapy and systemic antibiotics * As one of two preferred methods of contraception in patients with scarring and severe inflammatory acne being treated with systemic isotretinoin.

  6. 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.

  7. Cyproterone acetate in the treatment of acne vulgaris in adult females.

    PubMed

    Hansted, B; Reymann, F

    1982-02-01

    22 adult females with therapy-resistant acne vulgaris were treated for 12 months with Diane, a drug containing cyproterone acetate and ethinylestradiol. Treatment was withdrawn in 7 patients because of side-effects of lack of of effect. In the remaining 15 patients, the treatment had extremely promising results, from 70 to 90% improvement of the acne. In a remarkably high number of patients, the androgen production, measured by the urinary excretion of fractional 17-ketosteroids, was elevated. None of these patients had signs of endocrinological diseases, in particular no cases of hirsutism of Stein-Leventhal syndrome were found. The current concept of the course of acne is that the conversion in the skin of testosterone to dehydrotestosterone is increased. The finding of an elevated urinary excretion of androgenic substances in this group of acne patients indicates that the pathogenesis is far more complicated.

  8. 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

  9. 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

  10. [Clinical variants of acne].

    PubMed

    Jansen, T; Grabbe, S; Plewig, G

    2005-11-01

    Acne is a very common dermatosis with characteristic clinical features. It is a polymorphic disease. The clinical expression ranges from non-inflammatory closed and open comedones to inflammatory papules, pustules, and nodules. Most patients have a mixture of non-inflammatory and inflammatory lesions, although some have predominantly one or the other. Acne varies in severity from a very distressing, socially disabling disorder to a state that has been regarded as physiological by some authors. The most severe forms of acne are acne fulminans and acne inversa. Although acne may occur in all age groups, it is most prevalent during adolescence. It is not known why acne subsides in most patients but persists into adulthood in some. Certain medications may be associated with provocation, perpetuation, or exacerbation of pre-existing acne or with acneiform eruptions. Acne-like disorders include rosacea, pseudofolliculitis barbae, and other conditions that share clinical features with acne.

  11. Relationship between Propionibacterium acnes biotypes and Jumi-haidoku-to.

    PubMed

    Higaki, S; Kitagawa, T; Kagoura, M; Morohashi, M; Yamagishi, T

    2000-10-01

    We examined the relationship between Propionibacterium acnes biotypes and Jumi-haidoku-to (JHT). In all the P. acnes strains tested, the production of propionic acid (PA) and butyric acid (BA) was suppressed in a medium containing 1 mg/ml JHT compared with the control medium without JHT. There were no significant differences in the rates of decreased PA and BA production between P. acnes biotype 3 (B3) and the other biotypes or between isolates from mild skin rash and more severe skin rash. P. acnes B3 was the most commonly identified biotype. The clinical effects on acne due to the anti-P. acnes lipase activity of JHT did not seem to be influenced by the degree of acne rash or the P. acnes biotype.

  12. Acne fulminans with synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome treated with infliximab.

    PubMed

    Iqbal, Marvi; Kolodney, Michael S

    2005-05-01

    Acne fulminans is a syndrome of sudden onset hemorrhagic and ulcerative acne involving the back, chest, and face combined with systemic symptoms. It can be the dermatologic manifestation of the synovitis-acne-pustulosis-hyperostosis-osteitis (SAPHO) syndrome. Current therapy for acne fulminans consists of wound care, topical and systemic corticosteroids, isotretinoin, and nonsteroidal anti-inflammatory drugs (NSAIDs). Infliximab, a recently developed monoclonal antibody against tumor necrosis factor-alfa, has shown efficacy in the treatment of psoriatic arthritis and ankylosing spondylitis both of which share clinical similarities to the SAPHO syndrome. We report the case of a patient with the SAPHO syndrome and acne fulminans who was treated with infliximab. Ten months after initiating therapy with infliximab, the area of the patient's ulcerative lesions was reduced by 70%. Infliximab might be considered as a treatment option for patients with acne fulminans unresponsive to conventional therapies.

  13. 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.

  14. 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.

  15. 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.

  16. Newer approaches in topical combination therapy for acne.

    PubMed

    Fu, Lisa W; Vender, Ronald B

    2011-10-01

    Acne vulgaris is a common chronic inflammatory cutaneous disease involving the pilosebaceous unit. Its pathophysiology is multifactorial and complex, including obstruction of the pilosebaceous unit due to increased sebum production, abnormal keratinization, proliferation of Propionibacterium acnes (P. acnes), and inflammation. Topical agents are the most commonly used therapy for acne. First generation topicals mainly consist of single agent retinoids, benzoyl peroxide (BPO) and antibacterials that target comedones, P. acnes, and inflammation. Novel topical therapies include combination products with advanced vehicle formulations that target multiple acne pathophysiologies and offer simplified treatment regimes. For example, the combination of clindamycin and tretinoin in a unique vehicle formulation allows for progressive follicle penetration and decreased irritation, resulting in increased efficacy. Furthermore, adapalene or clindamycin with BPO combinations target comedones, inflammation, and P. acnes synergistically. These newer combination products have the potential to increase both efficacy and patient adherence when compared with single agent treatment.

  17. 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.

  18. Drugs@FDA: FDA Approved Drug Products

    MedlinePlus

    ... by Month Approvals, tentative approvals, and supplements Original New Drug Approvals (NDAs and BLAs) by Month All applications ... FDA. Does not include tentative approvals. Original Abbreviated New Drug Approvals (ANDAs) by Month Generic Drug Approvals. Does ...

  19. Acne in ethnic skin.

    PubMed

    Halder, Rebat M; Brooks, Howard L; Callender, Valerie D

    2003-10-01

    Acne is the most common disorder observed in ethnic skin. Clinical presentation is different than in white skin. Postinflammatory hyperpigmentation is a common sequelae of acne in darker skin. The management of acne in ethnic skin is based largely on the prevention and treatment of hyperpigmentation.

  20. Acne vulgaris associated with antigonadotropic (Danazol) therapy.

    PubMed

    Greenberg, R D

    1979-10-01

    A case of a young woman in whom nodulocystic acne developed while being treated for endometriosis with danazol, an antigonadotropic drug, is described herein. Although this agent, a derivative of 17 alpha-ethinyl testosterone, has been noted to possess weak androgenic properties, it has not been widely appreciated that danazol's androgenic side effects, particularly acne and seborrhea, occur frequently and may require prompt treatment.

  1. Propionibacterium acnes induces an interleukin-17 response in acne vulgaris that is regulated by vitamin A and vitamin D

    PubMed Central

    Agak, George W.; Qin, Min; Nobe, Jennifer; Kim, Myung-Hwa; Krutzik, Stephan R.; Tristan, Grogan R.; Elashoff, David; Garbán, Hermes J.; Kim, Jenny

    2014-01-01

    Acne vulgaris is the most common skin disorder affecting millions of people worldwide and inflammation resulting from the immune response targeting Propionibacterium acnes plays a significant role in its pathogenesis. In this study, we have demonstrated that P. acnes is a potent inducer of Th17 and Th1, but not Th2 responses in human PBMCs. P. acnes stimulated expression of key Th17-related genes, including IL-17A, RORα, RORc, IL-17RA and IL-17RC, and triggered IL-17 secretion from CD4+, but not CD8+ T cells. Supernatants from P. acnes-stimulated PBMCs were sufficient to promote the differentiation of naïve CD4+CD45RA T cells into Th17 cells. Furthermore, we found that the combination of IL-1β, IL-6 and TGF-β neutralizing antibodies completely inhibited P. acnes-induced IL-17 production. Importantly, we showed that IL-17-expressing cells were present in skin biopsies from acne patients but not from normal donors. Finally, vitamin A (all-trans retinoic acid) and vitamin D (1,25-dihydroxyvitamin D3) inhibited P. acnes-induced Th17 differentiation. Together, our data demonstrate that IL-17 is induced by P. acnes and expressed in acne lesions and that both vitamin A and vitamin D could be effective tools to modulate Th17-mediated diseases such as acne. PMID:23924903

  2. Multiple Activities of Punica granatum Linne against Acne Vulgaris

    PubMed Central

    Lee, Chia-Jung; Chen, Lih-Geeng; Liang, Wen-Li; Wang, Ching-Chiung

    2017-01-01

    Acne is a common skin condition with sebum overproduction, hyperkeratosis, Propionibacterium acnes (P. acnes) and Staphylococcus aureus, and inflammation. Punica granatum (pomegranate) is well-known for its anti-inflammatory effects; however, few studies have discussed the anti-acne effects of pomegranate. In this study, we found that pomegranate extract (PG-E) significantly reduced P. acnes-induced edema in Wistar rat ears. Therefore, an evaluation platform using multiple pathogenic mechanisms of acne was established to explore the anti-acne effects of pomegranate. Results showed that PG-E inhibited bacterial growth and lipase activity. Through a bioguided-fractionation-isolation system, four hydrolysable tannins, punicalagin (1), punicalin (2), strictinin A (3), and granatin B (4), were isolated. Compounds 1 and 2 had greater anti-bacterial activities and anti-testosterone-induced HaCaT proliferative effects than the others. Compounds 1, 3, and 4 displayed lipase inhibitory effects. Compound 4 decreased cyclooxygenase-2 expression and downregulated prostaglandin E2 production in heat-killed P. acnes-treated RAW 246.7 cells. In conclusion, PG-E is abundant in hydrolysable tannins that display multiple anti-acne capacities, including anti-bacterial, anti-lipase, anti-keratinocyte proliferation, and anti-inflammatory actions. Hence, PG-E has great potential in the application of anti-acne and skin-care products, and punicalagin (1), the most effective component in PG-E, can be employed as a quality control marker. PMID:28085116

  3. Acne and anticonvulsants.

    PubMed Central

    Greenwood, R; Fenwick, P B; Cunliffe, W J

    1983-01-01

    The severity of acne and rate of excretion of sebum were assessed in 243 patients with epilepsy taking various anticonvulsants who were in hospital long term and in matched controls derived from a normal population of 2176 people. Neither the prevalence of acne nor the sebum excretion rate significantly increased in the patients compared with the controls or in patients taking phenytoin compared with those not. It is concluded that anticonvulsant treatment does not cause acne. PMID:6227369

  4. [Treatment of acne].

    PubMed

    Fyrand, O

    1997-08-30

    Acne is a disfiguring disease, occurring mainly in adolescence. It is a common disorder, affecting above 80% of adolescents in some degree. 50% wish to have treatment for the condition. Acne appears in many forms; from the more common comedonal and papulopustular types to the often devastating cystic and fulminant acne. Some patients develop disfiguring scarring and keloidal reactions, which persist for the rest of their lives. With the treatment facilities available in modern medicine, acne problems can be eliminated through topical and/or systemic treatment options.

  5. [Treatment of acne].

    PubMed

    Delanoë, P; de Prost, Y

    1997-11-01

    The treatment of acne is based upon simple pathogenic arguments, but needs to be adapted to the type of acne. Patients must always be informed that it is long and difficult and that no significant response will be expected before 2 to 3 months of regular treatment. The authors present the different therapeutic agents and strategies. Isotretinoin should be used only in severe acne after failure of at least 3 months of a well conducted classical treatment and in nodulo-cystic acne; because of its major side effect of teratogenicity its use in adolescent girl's requires pregnancy testings before and during treatment and an effective contraception.

  6. Isotretinoin therapy for acne vulgaris: results in an Irish population.

    PubMed

    Buckley, D; Rogers, S; Daly, P

    1990-01-01

    The results of treatment of cystic and antibiotic-resistant acne vulgaris in 96 consecutive patients with the oral retinoid isotretinoin (13-cis-retinoic acid; Roacentane) are reported retrospectively. The results show that the drug, while toxic in the short term, is highly effective in clearing acne.

  7. 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

  8. 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.

  9. Update on acne therapy.

    PubMed

    O'Donoghue, M N

    1999-06-01

    Current therapy of acne vulgaris is very effective. It consists of a combination of topical comedolytic agents, antibacterial agents, and combinations of both. The use of systemic therapy with antibiotics, isotretinoin, and hormones is necessary for cystic acne. The management of patients with the various combinations of topical and systemic medications is discussed.

  10. Therapy of acne.

    PubMed

    Olsen, T G

    1982-07-01

    Today acne vulgaris is a disease which can be well controlled using a combination of topical, systemic, and physical therapeutic modalities. However, successful acne management depends to a large extent on physician interest and the ability of the physician to apply therapy to the evolutionary stage of the disease and to the disturbed pathogenetic mechanisms. It is this author's opinion that grades I and II comedonal and papulopustular acne can be effectively treated solely with topical preparations, particularly the concurrent use of tretinoin with benzoyl peroxide or topical antibiotics. The majority of patients with grades III and IV inflammatory disease require oral antibiotics in addition to aggressive topical treatments. Intralesional steroids can be effective in all grades of acne when lesions develop an inflammatory nodulocystic quality. The physician should consider the use of estrogen (in females) or oral vitamin A in the small group of patients with grades III and IV inflammatory-cystic acne that has been unresponsive to conventional therapy. Combined systemic therapies of high-dose antibiotics, systemic corticosteroids, and sulfones clearly take precedence over topical preparations in conglobate acne and acne fulminans. Finally, oral isotretinoin, alone and perhaps in combination with more conventional modalities, should play an important role in the future management of severe inflammatory-cystic acne.

  11. [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.

  12. The Antimicrobial Activity of Liposomal Lauric Acids Against Propionibacterium acnes

    PubMed Central

    Yang, Darren; Pornpattananangkul, Dissaya; Nakatsuji, Teruaki; Chan, Michael; Carson, Dennis; Huang, Chun-Ming; Zhang, Liangfang

    2009-01-01

    This study evaluated the antimicrobial activity of lauric acid (LA) and its liposomal derivatives against Propionibacterium acnes (P. acnes), the bacterium that promotes inflammatory acne. First, the antimicrobial study of three free fatty acids (lauric acid, palmitic acid and oleic acid) demonstrated that LA gives the strongest bactericidal activity against P. acnes. However, a setback of using LA as a potential treatment for inflammatory acne is its poor water solubility. Then the LA was incorporated into a liposome formulation to aid its delivery to P. acnes. It's demonstrated that the antimicrobial activity of LA was not only well maintained in its liposomal derivatives but also enhanced at low LA concentration. In addition, the antimicrobial activity of LA-loaded liposomes (LipoLA) mainly depended on the LA loading concentration per single liposomes. Further study found that the LipoLA could fuse with the membranes of P. acnes and release the carried LA directly into the bacterial membranes, thereby killing the bacteria effectively. Since LA is a natural compound that is the main acid in coconut oil and also resides in human breast milk and liposomes have been successfully and widely applied as a drug delivery vehicle in the clinic, the LipoLA developed in this work holds great potential of becoming an innate, safe and effective therapeutic medication for acne vulgaris and other P. acnes associated diseases. PMID:19665786

  13. Acne and its management beyond the age of 35 years.

    PubMed

    Marks, Ronnie

    2004-01-01

    Although acne is not usually considered to be a disorder that affects the elderly, the disorder occurs sufficiently often in mature individuals to be noteworthy. The variety known as 'persisting acne' is, as its name suggests, ordinary acne that continues into adult life. 'Chin acne' is a curious type that occurs premenstrually in mature women, while 'sporadic acne' describes the sudden development of significant acne in later life for no apparent reason. When acne develops in an individual outside the usual susceptible age group precipitating causes such as exposure to comedogenic substances or drugs must be excluded. Similarly, endocrine causes such as androgen-secreting tumors and the administration of anabolic steroids need to be considered. All inflammatory processes are decreased in the elderly and this may be one reason for the persistence and intransigence of acne lesions in older age groups. The principles of treatment of acne in the elderly do not differ from those in other age groups, although the emphasis during counseling needs to focus on explanation and reassurance rather than prognosis. Topical retinoids and benzoyl peroxide easily irritate elderly skin, so azelaic acid and even sulfur preparations are preferable. Low-dose systemic isotretinoin is reported to be helpful to patients in this age group and is certainly worth a trial.

  14. Pathogenesis of acne.

    PubMed

    Toyoda, M; Morohashi, M

    2001-03-01

    Acne vulgaris is a skin disorder of the sebaceous follicles that commonly occurs in adolescence and in young adulthood. The major pathogenic factors involved are hyperkeratinization, obstruction of sebaceous follicles resulting from abnormal keratinization of the infundibular epithelium, stimulation of sebaceous gland secretion by androgens, and microbial colonization of pilosebaceous units by Propionibacterium acnes, which promotes perifollicular inflammation. The clinical presentation of acne can range from a mild comedonal form to severe inflammatory cystic acne of the face, chest, and back. At the ultrastructural level, follicular keratinocytes in comedones can be seen to possess increased numbers of desmosomes and tonofilaments, which result in ductal hypercornification. The increased activity of sebaceous glands elicited by androgen causes proliferation of P. acnes, an anaerobe present within the retained sebum in the pilosebaceous ducts. The organism possesses a ribosome-rich cytoplasm and a relatively thick cell wall, and produces several biologically active mediators that may contribute to inflammation, for instance, by promoting leukocyte migration and follicular rupture. In inflamed lesions, numerous neutrophils and macrophages infiltrate around hair follicles and sometimes phagocytose P. acnes. To examine the participation of neurogenic factors in the pathogenesis of acne, we quantitatively assessed the effects of neuropeptides on the morphology of sebaceous glands in vitro using electron microscopy. Substance P, which can be elicited by stress, promoted the development of cytoplasmic organelles in sebaceous cells, stimulated sebaceous germinative cells, and induced significant increases in the area of sebaceous glands. It also increased the size of individual sebaceous cells and the number of sebum vacuoles for each differentiated sebaceous cell, all of which suggests that substance P promotes both the proliferation and the differentiation of sebaceous

  15. Are we underdosing acne patients with generic isotretinoin?

    PubMed

    Mutizwa, Misha M; Sheinbein, David M

    2013-01-15

    With Roche's withdrawl of Accutane from the U.S. market in 2009, isotretinoin has only been available in its generic form. Many clinicians fail to realize that for approval by the U.S. Food and Drug Administration, a generic medication must have a bioequivalence between 80 percent and 125 percent of that of the innovator product. This potential variability in bioavailability between branded and generic medications is important to keep in mind with isotretinoin, given the implications for achieving a sustained remission in acne patients.

  16. Efficacy and Tolerability of a Three-Step Acne System Containing a Solubilized Benzoyl Peroxide Lotion versus a Benzoyl Peroxide/Clindamycin Combination Product

    PubMed Central

    Del Rosso, James Q.

    2008-01-01

    A brand three-step acne treatment system containing a solubilized 5% benzoyl lotion and a designated cleanser and moisturizer was compared with a brand benzoyl peroxide 5%/clindamycin 1% gel in subjects with acne vulgaris. The single-center, four-week study was investigator-blinded and randomized. The three-step acne treatment system proved to be comparable in efficacy and tolerability. PMID:21203357

  17. Sex hormones and acne.

    PubMed

    Ju, Qiang; Tao, Tao; Hu, Tingting; Karadağ, Ayşe Serap; Al-Khuzaei, Safaa; Chen, WenChieh

    The skin is an endocrine organ with the expression of metabolizing enzymes and hormone receptors for diverse hormones. The sebaceous gland is the main site of hormone biosynthesis, especially for androgens, and acne is the classical androgen-mediated dermatosis. In sebocytes, conversion of 17-hydroxyprogesterone directly to dihydrotestosterone bypassing testosterone has been demonstrated, while type II 17β-hydroxysteroid dehydrogenase can inactivate the action of testosterone and dihydrotestosterone. The androgen receptor-dependent genomic effect of dihydrotestosterone on sebocytes is confirmed. Further evidence supports the PI3 K/Akt/FoxO1/mTOR signaling in the involvement of the interplay between androgens, insulin, insulin-like growth factor, and hyperglycemic diet in acne. Androgens not only regulate embryology and lipogenesis/sebum synthesis in sebocytes but also influence inflammation in acne. Genetic studies indicate that regulation of the androgen receptor is an important factor in severe acne. Further studies are required to understand the effect of estrogen and progesterone on sebaceous gland and comedogenesis, considering the change of acne in pregnancy and postmenopausal acne. Special attention should be paid to nonobese patients with polycystic ovarian syndrome and hyperandrogenism-insulin resistance-acanthosis nigricans syndrome. In spite of extensive gynecologic experience in the use of combined oral contraceptives for acne, evidence based on dermatologic observation should be intensified.

  18. Acne and smoking

    PubMed Central

    Capitanio, Bruno; Ottaviani, M; Bordignon, V; Amantea, A; Picardo, M

    2009-01-01

    Background. Post-adolescent acne is an inflammatory disorder, whose cause is unknown. Contrasting data are available on correlation between acne and smoking habit. Objectives. To verify the frequency of clinically non-inflammatory (atypical) post-adolescent acne (APAA) among women, a possible correlation with cigarette smoking, possible differences in sebum composition in a group of female smokers with acne compared to healthy smokers and non-smokers. Method and results. 1046 randomly selected women (25–50-years-old) participated at the study. In 60 selected female subjects we analyzed sebum composition for α-tocopherol, squalene and squalene monohydroperoxide. We found a high prevalence of APAA among women (74.6%), a strong correlation with smoking habit (p < 0.0001), as well as an increase in the grade of sebum peroxidation (p < 0.05) with a reduction in vitamin E (p = 0.02), in the subjects with acne compared to the controls. Conclusions. Clinical evidence and experimental data showed a straight correlation between smoking habit and post-pubertal acne in which the clinically non-inflammatory type—APAA—is the most frequent. In the more severe cases we could consider APAA as a new entity (smoker’s acne). PMID:20436880

  19. 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.

  20. 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.…

  1. 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.

  2. Pregnancy Acne: What's the Best Treatment?

    MedlinePlus

    ... week What's the best way to treat pregnancy acne? Answers from Lawrence E. Gibson, M.D. Pregnancy acne can be treated with self-care and medication. Pregnancy acne isn't a special form of acne. Some ...

  3. Acne scar subcision.

    PubMed

    Chandrashekar, Bs; Nandini, As

    2010-05-01

    Subcision is a simple and safe office surgery procedure for treatment of depressed acne scars. It can easily be combined with other treatments such as laser, dermaroller and scar revisions for maximum efficacy.

  4. Acne Scar Subcision

    PubMed Central

    Chandrashekar, BS; Nandini, AS

    2010-01-01

    Subcision is a simple and safe office surgery procedure for treatment of depressed acne scars. It can easily be combined with other treatments such as laser, dermaroller and scar revisions for maximum efficacy. PMID:21031076

  5. Bacteriophages infecting Propionibacterium acnes.

    PubMed

    Brüggemann, Holger; Lood, Rolf

    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.

  6. Teens and Acne Treatment

    MedlinePlus

    ... Pediatrician Ages & Stages Prenatal Baby Toddler Preschool Gradeschool Teen Dating & Sex Fitness Nutrition Driving Safety School Substance Abuse Young Adult Healthy Children > Ages & Stages > Teen > Teens and Acne Treatment Ages & Stages Listen Español ...

  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.

  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. The Role of Inflammation in the Pathology of Acne

    PubMed Central

    2013-01-01

    The conventional perspective of acne pathogenesis holds that Propionibacterium acnes colonizes the duct of the sebaceous follicle, causing an innate immune response and the progression from a so-called noninflammatory comedo to an inflammatory papule, pustule, or nodule. However, this viewpoint has come under increasing scrutiny over the last decade, as evidence has emerged supporting a role for inflammation at all stages of acne lesion development, perhaps subclinically even before comedo formation. The immunochemical pathways underlying the initiation and propagation of the inflammation in acne are complex and still being elucidated, but may involve Propionibacterium acnes as well as several inflammatory mediators and their target receptors, including cytokines, defensins, peptidases, sebum lipids, and neuropeptides. This review presents evidence to support the notion that acne is primarily an inflammatory disease, challenging the current nomenclature of noninflammatory versus inflammatory acne lesions and suggesting that the nomenclature is outdated and incorrect. The evidence in support of acne as an inflammatory disease also has clinical implications, in that anti-inflammatory drugs used to treat the disease can be expected to exert effects against all lesion stages, albeit via distinct mechanisms of anti-inflammation. PMID:24062871

  10. Acne Vulgaris in the Athlete.

    PubMed

    Conklin, R J; Taunton, J E

    1988-10-01

    In brief: The treatment of acne is basically the same for athletes and nonathletes. However, certain aspects of sports can affect acne adversely, and in some cases treating athletes may require a cautious approach. The best treatments are topical tretinoin for comedonal acne, benzoyl peroxide or topical antibiotics and tretinoin for comedonal and mild pustular acne, and a combination of oral antibiotics and long-term benzoyl peroxide or topical antibiotics (with the eventual aim of stopping the oral antibiotics in three to five months) for moderate to severe pustular acne. For severe cystic/nodular acne, highdose oral antibiotics and intralesional steroid injections or oral isotretinoin should be considered.

  11. 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.

  12. Advances in the treatment of acne.

    PubMed

    Kimball, Alexa B

    2008-09-01

    Acne vulgaris affects most people at some time in their life. This common condition can have devastating effects on a person's quality of life and may leave permanent scars. Treatment options, which are designed to disrupt one or more of the pathogenic features that characterize acne, include topical therapies (e.g., antibiotics, retinoids, benzoyl peroxide and combination products), systemic treatments (e.g., oral antibiotics, hormonal therapies and oral retinoids, which are indicated for severe recalcitrant nodulocystic acne), and, to a lesser extent, light-based and physical treatments. Combination oral contraceptives (COCs) represent one type of hormonal treatment. Their mode of action is to reduce the availability of free testosterone, which stimulates the sebaceous glands to produce sebum. Most COCs used in the United States contain progestins derived from 19-nortestosterone, giving them at least some degree of androgenic activity. Of the 3 COCs with an FDA indication for the treatment of moderate acne, only YAZ contains drospirenone, a progestin that combines no androgenic activity with antiandrogenic activity. This drospirenone-containing COC has been shown to be effective in reducing both inflammatory and noninflammatory acne lesions.

  13. Treatment of hirsutism and acne in hyperandrogenism.

    PubMed

    Moghetti, Paolo; Toscano, Vincenzo

    2006-06-01

    Hirsutism and acne are common and highly distressing complaints in women with polycystic ovary syndrome (PCOS). Drugs are only partially effective on terminalized hairs, and removal of these hairs is usually required. Therefore, management of hirsutism is generally based upon a dual approach: a pharmacological therapy to reduce androgen secretion and/or androgen action, and removal of terminal hair already present. Ovarian suppression of androgen secretion with oral contraceptives is widely used in these women, but its efficacy appears limited. The most effective medical therapy for hirsutism is by anti-androgen drugs. Electrolysis and laser photothermolysis are considered the most effective cosmetic procedures, although the effects of these methods should not be considered permanent. Acne may be treated with different tools, according to the severity of the condition and other characteristics of the patient. These tools include topical and systemic retinoids and antibiotics, topical antibacterial agents, androgen suppression by oral contraceptives, and anti-androgen drugs.

  14. Orphan drugs: the question of products liability.

    PubMed

    Scharf, S F

    1985-01-01

    Orphan drugs, essential for the treatment of persons with rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote the development of orphan drugs have met with modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes the provisions of the Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that the goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, the Note acknowledges that liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers' liability concerns.

  15. Acne: clinical presentations.

    PubMed

    Shalita, Alan R

    2004-01-01

    Acne vulgaris, the most common disease of the skin, can be manifested in a wide variety of clinical presentations. As a result of this clinical variation, there are almost as many classifications of acne as there are clinicians with particular interest in the disease. Thus acne has been classified as types I-IV, inflammatory versus noninflammatory, comedonal, comedopapular, papular, papulopustular, pustular, and "cystic" or nodular (even nodular-cystic). For those who are enamored of classification, there are subdivisions of the various categories, including "sandpaper comedones" and microcysts. There is even disagreement as to what constitutes a papule versus a nodule. The classic textbook definition of a nodule refers to lesions 1 cm or larger, but the early investigators of oral isotretinoin defined nodules as 4 mm or larger, and this definition has creeped into many texts, recently clarified by Bologna.(1)

  16. Neonatal and infantile acne vulgaris: an update.

    PubMed

    Serna-Tamayo, Cristian; Janniger, Camila K; Micali, Giuseppe; Schwartz, Robert A

    2014-07-01

    Acne may present in neonates, infants, and small children. Neonatal and infantile acne vulgaris are not considered to be rare. The presentation of acne in this patient population sometimes represents virilization and may portend later development of severe adolescent acne. Neonatal and infantile acne vulgaris must be distinguished from other cutaneous disorders seen in newborns and infants. Infantile acne tends to be more pleomorphic and inflammatory, thus requiring more vigorous therapy than neonatal acne.

  17. Auto-classification of acne lesions using multimodal imaging.

    PubMed

    Patwardhan, Sachin V; Kaczvinsky, Joseph R; Joa, James F; Canfield, Douglas

    2013-07-01

    Differentiating inflammatory and non-inflammatory acne lesions and obtaining lesion counts is pivotal part of acne evaluation. Manual lesion counting has reliably demonstrated the clinical efficacy of anti-acne products for decades. However, maintaining assessment consistency within and across acne trials is an important consideration since lesion counting can be subjective to the individual evaluators, and the technique has not been rigorously standardized. VISIA-CR is a multi-spectral and multi-modal facial imaging system. It captures fluorescence images of Horn and Porphyrin, absorption images of Hemoglobin and Melanin, and skin texture and topography characterizing broad-spectrum polarized and non-polarized images. These images are analyzed for auto-classification of inflammatory and non-inflammatory acne lesion, measurement of erythema, and post-acne pigmentation changes. In this work the accuracy of this acne lesion auto-classification technique is demonstrated by comparing the auto-detected lesions counts with those counted by expert physicians. The accuracy is further substantiated by comparing and confirming the facial location and type of every auto-identified acne lesion with those identified by the physicians. Our results indicate a strong correlation between manual and auto-classified lesion counts (correlation coefficient >0.9) for both inflammatory and non inflammatory lesions This technology has the potential to eliminate the tedium of manual lesion counting, and provide an accurate, reproducible, and clinically relevant evaluation of acne lesions. As an aid to physicians it will allow development of a standardized technique for evaluating acne in clinical research, as well as accurately choosing treatment options for their patients according to the severity of a specific lesion type in clinical practice

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

  19. 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...

  20. 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...

  1. 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...

  2. Cosmeceuticals based on Rhealba(®) Oat plantlet extract for the treatment of acne vulgaris.

    PubMed

    Fabbrocini, G; Saint Aroman, M

    2014-12-01

    Recent evidence suggests that acne vulgaris begins as an inflammation in and around the sebaceous gland and alterations in the lipid content of sebum, which drive hyperproliferation and increased desquamation of keratinocytes within sebaceous follicles. This prevents sebum drainage, causing the formation of microcomedones, which spontaneously regress or become acne lesions when the pilosebaceous unit is further blocked by the accumulation of corneocytes. These conditions are favourable for the proliferation of Propionibacterium acnes, which further aggravates acne by enhancing abnormal desquamation, sebum production and inflammation. Also, skin fragility due to inflammation or irritation by anti-comedogenic agents can worsen the situation. Rhealba(®) Oat plantlet extract (Pierre Fabre Dermo Cosmetique) soothes and restores fragile skin in acne by reducing inflammation and inhibits bacterial adhesion of Propionibacterium acnes. Cosmeceuticals combining Rhealba(®) Oat plantlet extract and hydro-compensating actives, which are available with or without anti-comedogenic hydroxy acids, provide a balanced, multifaceted approach for acne patients.

  3. 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.

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

    PubMed Central

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

    1995-01-01

    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

  5. Nanomaterial Drug Products: Manufacturing and Analytical Perspectives.

    PubMed

    Sayes, Christie M; Aquino, Grace V; Hickey, Anthony J

    2017-01-01

    The increasing use of nanotechnology, including nanoparticles, in the preparation of drug products requires both manufacturing and analytical considerations in order to establish the quality metrics suitable for performance and risk assessment. A range of different nanoparticle systems exists including (but not limited to) nano-drugs, nano-additives, and nano-carriers. These systems generally require more complex production and characterization strategies than conventional pharmaceutical dosage forms. The advantage of using nanoparticle systems in pharmaceutical science is that the effective and desired function of the material can be designed through modern manufacturing processes. This paper offers a systematic nomenclature which allows for greater understanding of the drug product under evaluation based on available data from other nanoparticle reports. Analytical considerations of nano-drugs, nano-additives, and nano-carriers and the way in which they are measured are directly connected to quality control. Ultimately, the objective is to consider the entire nano-drug, nano-additive, and nano-carrier product life cycle with respect to its manufacture, use, and eventual fate. The tools and approaches to address the needs of these products exist; it should be the task of the pharmaceutical scientists and those in related disciplines to increase their understanding of nanomedicine and its novel products.

  6. Induction of oxidative stress in rat brain by acrylonitrile (ACN).

    PubMed

    Jiang, J; Xu, Y; Klaunig, J E

    1998-12-01

    Chronic treatment with acrylonitrile (ACN) has been shown to produce a dose-related increase in glial cell tumors (astrocytomas) in rats. The mechanism(s) for ACN-induced carcinogenicity remains unclear. While ACN has been reported to induce DNA damage in a number of short-term systems, evidence for a genotoxic mechanism of tumor induction is the brain is not strong. Other toxic mechanisms appear to participate in the induction of tumor or induce the astrocytomas solely. In particular, nongenotoxic mechanisms of carcinogen induction have been implicated in this ACN-induced carcinogenic effect in the rat brain. One major pathway of ACN metabolism is through glutathione (GSH) conjugation. Extensive utilization and depletion of GSH, an important intracellular antioxidant, by ACN may lead to cellular oxidative stress. The present study examined the ability of ACN to induce oxidative stress in male Sprague-Dawley rats. Rats were administered ACN at concentrations of 0, 5, 10, 100, or 200 ppm in the drinking water and sampled after 14, 28, or 90 days of continuous treatment. Oxidative DNA damage indicated by the presence of 8-hydroxy-2'-deoxyguanosine (OH8dG) and lipid peroxidation indicated by the presence of malondialdehyde (MDA), a lipid peroxidation product, in rat brains and livers were examined. The levels of reactive oxygen species (ROS) were also determined in different rat tissues. Both the levels of nonenzymatic antioxidants (GSH, vitamin E) and the activities of enzymatic antioxidants (catalase, superoxide dismutase, glutathione peroxidase) in rat brains and livers were measured. Increased levels of OH8dG, MDA, and ROS were found in the brains of ACN-treated rats. Decreased levels of GSH and activities of catalase and SOD were also observed in the brains of ACN-treated rats compared to the control group. Interestingly, there were no changes of these indicators of oxidative stress in the livers of ACN-treated rats. Rat liver is not a target for ACN

  7. [Treatment of acne by isotretinoin (general course)].

    PubMed

    Chivot, Martine

    2002-04-15

    Acne is a chronic disease which evolves under periodic eruptions. Resolution occurs around the late teens. Conventional treatment clears the lesions, but treatment by isotretinoin alone can achieve long remissions indeed definitive clearing. Indications are nodulo-cystic acne and resistant acne to a conventional treatment of at least 3 months duration. This drug is prescribed in cures, a cure is the period during which the patient receives a continuous treatment. The daily dose is computed according to the patient's weight and varies between 0.5 and 1 mg/kg. To prevent relapses, it is recommended to cumulate a dose between 100 and 150 mg/kg. No other topical or systemic treatment is needed. Side effects exist, among which teratogenicity is the most severe. Very strict contraception is necessary for women of child-bearing age. The most important mucocutaneous side effect is dryness and has to be counteracted by emollients. It is recommended that the drug be prescribed by doctors having a fair experience of oral retinoids and a perfect understanding of the teratogenic risk of the drug.

  8. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris

    PubMed Central

    Baldwin, Hilary; Blanco, Daisy; McKeever, Charles; Paz, Nelly; Vasquez, Ynca Nina; Quiring, John; De León, Emily; Stasko, Nathan

    2016-01-01

    Objective: To compare efficacy, tolerability, and safety of two concentrations of topical SB204 and vehicle twice daily for 12 weeks in the treatment of acne vulgaris. Design: Randomized, double-blind, placebo-controlled, three-arm, Phase 2 study. Setting: Dominican Republic, Panama, and Honduras. Participants: Subjects with acne, age 12 to 40, with 25 to 70 noninflammatory lesions, 20 to 40 inflammatory lesions, and a baseline Investigator’s Global Assessment score of mild, moderate, or severe. Measurements: The primary efficacy assessment was the absolute change in noninflammatory lesion counts. Other assessments included inflammatory lesion counts, success on dichotomized Investigator’s Global Assessment, reported adverse events, physical examinations, laboratory testing, and tolerability. Results: One hundred fifty-three subjects were randomized to vehicle (n=52), SB204 1% (n=51), or SB204 4% (n=50). When compared to vehicle, subjects treated with SB204 1% and SB204 4% had significantly greater mean percent reduction in noninflammatory lesions from baseline and subjects treated with SB204 4% had a significantly greater mean percent reduction in inflammatory lesion count from baseline at Week 12. There were no significant differences in the IGA success rates between groups. Both concentrations of SB204 were safe and well-tolerated. Conclusions: When compared to vehicle, both SB204 1% and SB204 4% significantly decreased the percentage of noninflammatory lesions and SB204 4% also significantly decreased the percentage of inflammatory lesions in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 1% and SB204 4% was safe and well-tolerated. Registry: clinicaltrials.gov (NCT01844752). PMID:27672413

  9. 21 CFR 341.78 - Labeling of expectorant 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 expectorant drug products. 341.78 Section 341.78 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...

  10. 21 CFR 341.76 - Labeling of bronchodilator 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 bronchodilator drug products. 341.76 Section 341.76 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...

  11. Treatment of acne in children.

    PubMed

    Yeo, Lindsey; Ormerod, Anthony D

    2014-04-01

    Acne is a common skin condition in adolescents. It is not uncommon in childhood and it persists into adulthood. A broad range of acne treatments are available and have been shown to be safe and effective in adolescents and adults. However, there is limited literature regarding acne treatment in childhood and its available therapeutic options. It seems reasonable to extrapolate findings of the various studies reported on treatment of acne in the adolescent and adult age group, with the exclusion of the use of tetracycline derivatives. As clinicians, we must be more familiar with the clinical presentation of acne and available treatment options in our younger patients. Early recognition of acne with prompt and appropriate initiation of therapy in childhood will help prevent severe scarring in children.

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

    PubMed

    Kapuścińska, Alicja; Nowak, Izabela

    2015-03-22

    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.

  13. 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.

  14. Objective assessment of acne.

    PubMed

    Becker, Markus; Wild, Thomas; Zouboulis, Christos C

    A precise and reliable assessment of acne severity is unarguably the most essential clinical method when it comes to monitoring and choosing optimal treatment in the daily practice. Since the early 1960s, different severity assessment systems have been described in the literature. The two commonly used concepts are global gradings and lesion counting. Both systems have been controversially discussed as to which is more reliable and providing an objective outcome measurement tool; however, both have some subjectivity involved. More objective methods for assessing the severity of acne vulgaris include photography, fluorescence photography, polarized light photography, video microscopy, and multispectral imaging. Such techniques have limitations such as high cost, complex and sophisticated apparatus, and a sometimes time-consuming imaging process. There are newly developed technologies that could avoid the problems of inter- and intrarater subjectivity.

  15. Non-acne dermatologic indications for systemic isotretinoin.

    PubMed

    Akyol, Melih; Ozçelik, Sedat

    2005-01-01

    Systemic isotretinoin has been used to treat severe acne vulgaris for 20 years. However, isotretinoin also represents a potentially useful choice of drugs in many dermatologic diseases other than acne vulgaris. Diseases such as psoriasis, pityriasis rubra pilaris, condylomata acuminata, skin cancers, rosacea, hidradenitis suppurativa, granuloma annulare, lupus erythematosus and lichen planus have been shown to respond to the immunomodulatory, anti-inflammatory and antitumor activities of the drug. Isotretinoin also helps prevent skin cancers such as basal cell carcinoma or squamous cell carcinoma. A combination of systemic isotretinoin and interferon-alpha-2a may provide a more potent effect than isotretinoin alone in the prevention and treatment of skin cancers.Systemic isotretinoin may be considered as an alternative drug in some dermatologic diseases unresponsive to conventional treatment modalities. However, randomized clinical trials aimed at determining the role of systemic isotretinoin therapy in dermatologic diseases other than acne vulgaris are required.

  16. 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.

  17. 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).

  18. Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

    MedlinePlus

    ... premature birth Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

  19. Combination Therapy for Acne Scarring: Personal Experience and Clinical Suggestions.

    PubMed

    Kroepfl, Lucija; Emer, Jason J

    2016-11-01

    clinical improvement appreciated by the patient. Here we present personal experiences of combination treatments for acne scarring, pigmentation and textural issues, and suggest that fractional radiofrequency be considered a "gold standard" treatment of acne scarring in those with dark or sensitive skin types or those on concurrent isotretinoin. J Drugs Dermatol. 2016;15(11):1413-1419..

  20. Chemical peels in active acne and acne scars.

    PubMed

    Kontochristopoulos, Georgios; Platsidaki, Eftychia

    Chemical peeling is a widely used procedure in the management of acne and acne scars. It causes controlled destruction of a part of or the entire epidermis, with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by regeneration of new epidermal and dermal tissues. The most frequently used peeling agents are salicylic acid, glycolic acid, pyruvic acid, lactic acid, mandelic acid, Jessner solution, trichloroacetic acid, and phenol. The appropriate peel is chosen based on the patient's skin type, acne activity, and type of acne scars. Combination peels minimize side effects. In acne scars, chemical peels may be combined with other procedures to achieve better clinical results. A series of chemical peels can lead to significant improvement over a short period, leading to patient satisfaction and maintenance of clinical results. © 2016 Elsevier Inc. All rights reserved.

  1. 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.

  2. Importance of vehicles in acne therapy.

    PubMed

    Kircik, Leon H

    2011-06-01

    Topiucal drug therapy is an intuitively sound approach to the management of skin diseases. Depositing medication at the site of disease involvement is potentially effective and reduces systemic exposure. Topical drugs are absorbed usually by passive diffusion. In clinical practice, the choice of an optimized formulation that will be effective and well tolerated is essential. Data confirm that patient adherence with therapy leads to better outcomes and lower long-term treatment costs, while poor adherence is directly linked to poor treatment outcomes and and patient dissatisfaction. Local cutaneous irritation, which may be linked to components of the formulation and/or to the active drug itself, is a common cause of non-adherence. Well-designed drugs are important in the management of acne vulgaris and acne rosacea. Formulators have sought to improve treatment efficacy and tolerability by several different techniques, such as delayed release of the active drug, fixed combinations of two different molecules, or incorporating ingredients into the formulation vehicle that improve epidermal barrier function and offset the irritating effects of the active drugs.

  3. Polycystic ovary syndrome and acne.

    PubMed

    Chuan, Sandy S; Chang, R Jeffrey

    2010-01-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive aged women. It is typically characterized by hyperandrogenism, chronic anovulation, and polycystic ovaries. Women with PCOS often experience dermatologic manifestations of hyperandrogenism, including hirsutism, acne vulgaris, and androgenic alopecia. This article will review the treatments for acne due to androgen excess in PCOS women.

  4. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false New drug product exclusivity. 314.108 Section 314.108 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 Applications...

  5. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false New drug product exclusivity. 314.108 Section 314.108 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 Applications...

  6. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false New drug product exclusivity. 314.108 Section 314.108 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 Applications...

  7. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false New drug product exclusivity. 314.108 Section 314.108 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 Applications...

  8. Combination of a new radiofrequency device and blue light for the treatment of acne vulgaris.

    PubMed

    Braun, Martin

    2007-08-01

    Acne vulgaris is the most common skin disease treated by physicians. Current topical and oral treatments may have short- and long-term negative consequences. Since radiofrequency (RF) energy has been shown to reduce sebum production and 410-nm blue light has been shown to kill Propionibacterium acnes (P. acnes) cells, these modalities in combination should be a highly effective treatment of acne vulgaris with little or no downtime or risk. This case report describes the efficacy and safety of RF energy (Accent, Alma Lasers Inc, Buffalo Grove, IL) and blue light (BLU-U, Dusa Pharmaceuticals, Inc, Wilmington, MA) used in combination to treat grade 4 cystic acne and acne scars in an Asian woman of skin type IV. The results were considered excellent by both investigators and the patient, with improvement in the skin tone as an added cosmetic benefit.

  9. 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.

  10. Acne and hirsuties in teenagers.

    PubMed

    Barth, Julian H; Clark, Sheila

    2003-02-01

    Acne and body hair are both cutaneous responses to androgenic stimulation. They are normal events in adolescent girls. There is considerable variation in the evolution of the two conditions. The sebaceous gland is exquisitely sensitive to androgens, and acne appears with the onset of puberty, peaks in prevalence in the teenage years and gradually improves thereafter. Hair growth on the face, trunk and limbs develops more slowly and generally peaks in the 20s. Indications for endocrine investigation include very severe acne, onset of acne and hirsuties in the very early stage of puberty (Tanner stage 3) and systemic virilism. Treatment for acne and hirsuties can be either topical or systemic. The choice of therapy is based on the severity of the disease rather than the results of endocrine investigation. Further, since PCO is related to impaired glucose tolerance, advice relating to lifestyle changes should be offered to prevent the development of diabetes.

  11. An epidemiologic postmarketing surveillance study of prescription acne medications.

    PubMed Central

    Facklam, D P; Gardner, J S; Neidert, G L; Westland, M M

    1990-01-01

    After the Food and Drug Administration approved a topical antibiotic for the treatment of acne, we began a postmarketing surveillance study to measure the frequency of antibiotic-associated colitis and diarrhea in acne patients treated with topical antibiotics and low doses of oral antibiotics. Pharmacists recruited 13,465 patients who presented a prescription for an acne medication, and we obtained detailed information on the use of the medications, perceived acceptability, and the occurrence of new health events from 6,453 with computer-assisted telephone interviews. Three cases (less than 0.1%) of antibiotic-associated diarrhea and one case (less than 0.1%) of antibiotic-associated colitis were confirmed. We conclude that this methodology can provide further information about the safety of a drug once it is in customary use, at a fraction of the cost of Phase III clinical trials. PMID:2136713

  12. 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.

  13. The possible role of diet in the pathogenesis of adult female acne

    PubMed Central

    Woźniak, Magdalena; Kaczmarek-Skamira, Elżbieta; Zegarska, Barbara

    2016-01-01

    Acne in adults is a chronic, increasingly common disease, especially among women. It differs in pathogenesis and clinical presentation from adolescent acne. Acne in adults is associated with Western diet, defined as high consumption of milk, high glycemic load and high calorie intake. Metabolic signals of this diet result in a significant increase in insulin/insulin growth factor 1 serum level and consequently in the molecular interplay of mammalian target of rapamycin complex 1 kinase (mTORC1)/forkhead box protein 1 (FoxO1) mediated nutrient signaling, leading to increased proliferation of keratinocytes, increased lipogenesis and sebum production and finally to aggravation of acne. PMID:28035217

  14. 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

  15. Antibacterial Cleaning Products and Drug Resistance

    PubMed Central

    Marshall, Bonnie; Levy, Stuart B.; Della-Latta, Phyllis; Lin, Susan X.; Larson, Elaine

    2005-01-01

    We examined whether household use of antibacterial cleaning and hygiene products is an emerging risk factor for carriage of antimicrobial drug–resistant bacteria on hands of household members. Households (N = 224) were randomized to use of antibacterial or nonantibacterial cleaning and hygiene products for 1 year. Logistic regression was used to assess the influence of antibacterial product use in homes. Antibacterial product use did not lead to a significant increase in antimicrobial drug resistance after 1 year (odds ratio 1.33, 95% confidence interval 0.74–2.41), nor did it have an effect on bacterial susceptibility to triclosan. However, more extensive and longer term use of triclosan might provide a suitable environment for emergence of resistant species. Further research on this issue is needed. PMID:16318697

  16. Combination azelaic acid therapy for acne vulgaris.

    PubMed

    Webster, G

    2000-08-01

    There is no topical antiacne medication that acts against all four of the major pathophysiologic features of acne: hyperkeratinization, sebum production, bacterial proliferation, and inflammation. Topical azelaic acid cream helps both to normalize keratinization and to reduce the proliferation of Propionibacterium acnes, and has proven to be effective against both noninflammatory and inflammatory lesions. The results of a recent study now demonstrate that its efficacy can be enhanced, and patient ratings of overall impression improved, when it is used in combination with other topical medications such as benzoyl peroxide 4% gel, clindamycin 1% gel, tretinoin 0.025% cream, and erythromycin 3%/benzoyl peroxide 5% gel. Furthermore, another study has shown that azelaic acid plus benzoyl peroxide achieves greater efficacy and higher patient ratings of convenience than monotherapy with erythromycin-benzoyl peroxide gel.

  17. Tropical Acne: Clinical and Laboratory Investigations.

    DTIC Science & Technology

    developed in the tropical acne patients were clinically and histopathologically identical to those seen in severe pustular, cystic acne patients. The...Observations were made on the clinical, biochemical, histopathological and microbiological parameters of eleven ’tropical acne patients.’ All...tropical acne patients in the study had a previous history of mild to moderate acne vulgaris prior to their tour in Vietnam. The type of lesions which

  18. 21 CFR 336.50 - Labeling of antiemetic drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... chronic bronchitis or who have glaucoma, without first consulting the child's doctor.” (2) For products... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of antiemetic drug products. 336.50 Section 336.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  19. 21 CFR 355.50 - Labeling of anticaries 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 anticaries drug products. 355.50 Section 355.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... identity if the product also has a cosmetic use, as defined in section 201(i) of the Federal Food,...

  20. 21 CFR 355.50 - Labeling of anticaries 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 anticaries drug products. 355.50 Section 355.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... identity if the product also has a cosmetic use, as defined in section 201(i) of the Federal Food,...

  1. 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...

  2. 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...

  3. 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 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 21 CFR 314.108 - New drug product exclusivity.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... investigation means any experiment other than a bioavailability study in which a drug is administered or... 21 Food and Drugs 5 2014-04-01 2014-04-01 false New drug product exclusivity. 314.108 Section 314.108 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  10. 21 CFR 335.50 - Labeling of antidiarrheal 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 antidiarrheal drug products. 335.50 Section 335.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 21 CFR 335.50 - Labeling of antidiarrheal 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 antidiarrheal drug products. 335.50 Section 335.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and...

  18. 21 CFR 335.50 - Labeling of antidiarrheal 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 antidiarrheal drug products. 335.50 Section 335.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and...

  19. [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.

  20. 77 FR 71803 - Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... HUMAN SERVICES Food and Drug Administration Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  1. 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.

  2. Acne fulminans: a case report.

    PubMed

    Neely, Gregory M; Hein, Michael S

    2006-09-01

    Acne Fulminans (AF) is a severe form of cystic acne primarily affecting Caucasian adolescent males. The systemic clinical manifestations of the disease make it likely that the patient will present to his or her primary care provider rather than to a dermatologist. Promptly recognizing this disorder will aid in appropriate management, avoiding costly and invasive diagnostic procedures, multiple consultations, unnecessary pharmacologic treatments, and residual scarring of the skin. We report a case and a brief review of the literature regarding this enigmatic disorder.

  3. [Acne rosacea--diagnostic challenge].

    PubMed

    Wozniacka, Anna; Kruk, Małgorzata; Robak, Ewa; Sysa-Jedrzejowska, Anna

    2006-01-01

    Acne rosacea is a common skin disorder which affects adults, usually women. Erythema, papules, pustules and telangiectases, the main clinical manifestations of the disease are located on the face. Currently opinions dealing with pathogenesis and clinical forms of rosacea are presented. As the clinical picture might be confusing, similar to other illnesses, differential diagnosis with other dermatoses like acne vulgaris, erysipelas, seborrhoeic and contact eczema as well as systemic diseases like lupus erythematosus, dermatomyositis, scleroderma, sarcoidosis and leukemia were discussed.

  4. New Developments in Acne Treatment

    PubMed Central

    Stolman, Lewis P.

    1982-01-01

    Acne is a metabolic disorder of the pilosebaceous appendage in which microorganisms, hormones, inflammatory cells and fatty acids seem to contribute to the pathologic process. Through education and judicious use of therapeutic agents including benzoyl peroxide, vitamin A acid, topical and systemic antibiotics and 13 cis retinoic acid, most patients with acne can enjoy good control of their disease. ImagesFig. 2Fig. 3Fig. 4 PMID:21286149

  5. 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.

  6. The Psychosocial Impact of Acne Vulgaris

    PubMed Central

    Hazarika, Neirita; Archana, M

    2016-01-01

    Background: Acne vulgaris causes erythematous papulopustular lesions in active stage and often leave behind residual scarring and pigmentation. Its onset in adolescence may add to the emotional and psychological challenges experienced during this period. Aims: To assess the impact of acne on the various psychosocial domains of daily life. Materials and Methods: This was a prospective, cross-sectional study done in the dermatology out-patient department of a tertiary care hospital from January to March 2015. A total of 100 consecutive, newly diagnosed patients of acne vulgaris, aged 15 years and above were included in this study. The relationship between acne vulgaris and its sequelae was analyzed with ten different domains of daily life by using dermatology life quality index (DLQI) questionnaire. Results: Females (56%), 15–20 year olds (61%), facial lesions (60%), and Grade II acne (70%) were most common. Acne scars were noted in 75% patients, whereas 79% cases had post-acne hyperpigmentation. Thirty-seven percent patients had DLQI scores of (6–10) interpreted as moderate effect on patient's life. Statistically significant correlation (P < 0.05) found were as follows: Physical symptoms with grade of acne; embarrassment with site and grade of acne; daily activities with grade of acne and post-acne pigmentation; choice of clothes with site of acne; social activities with gender, site and grade of acne; effect on work/study with grade of acne; interpersonal problems with site and post-acne pigmentation; sexual difficulties with grade of acne. Limitation: It was a hospital-based study with small sample size. Conclusion: Significant impact of acne and its sequelae was noted on emotions, daily activities, social activities, study/work, and interpersonal relationships. Assurance and counseling along with early treatment of acne vulgaris is important to reduce disease-related psychosocial sequelae and increase the efficacy of treatment. PMID:27688440

  7. 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.

  8. 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.

  9. 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.

  10. 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...

  11. 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.

  12. Environmental pollution and acne: Chloracne.

    PubMed

    Ju, Qiang; Zouboulis, Christos C; Xia, Longqing

    2009-05-01

    Environmental pollutants can result in a variant of acne called 'chloracne'. Chloracne is caused by systemic exposure to certain halogenated aromatic hydrocarbons 'chloracnegens', and is considered to be one of the most sensitive indicators of systemic poisoning by these compounds. Dioxin is the most potent environmental chloracnegen. Most cases of chloracne have resulted from occupational and non-occupational exposures, non-occupational chloracne mainly resulted from contaminated industrial wastes and contaminated food products. Non-inflammatory comedones and straw-colored cysts are the primary clinical manifestation of chloracne. Increasing of cysts in number is a signal of aggravation of chloracne. Generalized lesions can appear on the face, neck, trunk, exterimities, genitalia, axillary and other areas. Course of chloracne is chronic. Severity of chloracne is related to dosage of exposed chloracnegens, chloracnegenic potency and individual susceptibility. Histopathology of chloracne is characterized mainly by hyperplasia of epidermal cell, while follicular and sebaceous gland are taken placed by keratinized epidermal cell. The pathogenesis of chloracne maybe related to the imbalance of epidermal stem cell. Chloracne appears to be resistant to all tested forms of treatment. The only way to control chloracne is to prevent exposure to chloracnegens.

  13. 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

  14. [Adjuvant dermato-cosmetic acne therapy].

    PubMed

    Bayerl, Christiane; Degitz, Klaus; Meigel, Eva; Kerscher, Martina

    2010-03-01

    Adjuvant dermato-cosmetic therapy in acne is an essential part of the concept of treating acne after initiation and during maintenance therapy. Those are mechanical peeling, chemical peeling and its combination. It needs supervision by an experienced dermatologist.

  15. 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 ...

  16. 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 ...

  17. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

    PubMed Central

    2013-01-01

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug

  18. 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

  19. 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.

  20. 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... Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act. (a)...

  1. 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)...

  2. 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

  3. [Efficacy of oral contraceptives on acne. Apropos of a comparative study of Varnoline vs Diane in 69 women with acne].

    PubMed

    Levrier, M; Degrelle, H; Bestaux, Y; Bourry-Moreno, M; Brun, J P; Sailly, F

    1988-01-01

    The authors conducted a comparative study of the effect of two oral contraceptives Varnoline and Diane in the treatment of androgenic manifestations: acne and hirsutism. The two products tested seem to have a similar efficacy on this type of clinical manifestations.

  4. 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.

  5. Management of acne vulgaris: an evidence-based update.

    PubMed

    Ingram, J R; Grindlay, D J C; Williams, H C

    2010-06-01

    This review summarizes clinically important findings from 3 systematic reviews, 1 updated guideline and a selection from the 62 randomized controlled trials (RCTs) published between February 2007 and January 2009 on the topic of acne vulgaris. Low glycaemic-load diets might reduce acne severity but this remains unproven. Written patient information leaflets have not been surpassed by other communication methods. New combination topical treatments have not shown convincing advantages over current combination products such as clindamycin/benzoyl peroxide. Topical dapsone is superior to placebo but has yet to be compared with standard topical treatments. Long-term topical tretinoin to prevent nonmelanoma skin cancer in elderly men was associated with higher all-cause mortality, but there is currently no evidence of increased mortality for topical retinoid use when treating acne. All oral tetracyclines have similar efficacy, yet minocycline is the most costly. Oral isotretinoin monotherapy remains the gold-standard treatment for severe acne. Flutamide plus the oral contraceptive pill is beneficial for acne associated with polycystic ovary syndrome. Photodynamic therapy, phototherapy and laser therapy cannot be recommended universally for acne until minimal postinflammatory pigmentation and longer-term benefit can be shown, especially with current high costs. Development of non-antibiotic therapies is preferable to minimize the risk of community antibiotic resistance. Future trials should use active comparators at optimum doses and avoid noninferiority comparisons unless appropriately powered. Trials need to shift from using multiple, unvalidated outcome measures to including patient-reported and quality-of-life outcomes, and all trials should be registered on a public clinical-trials database.

  6. Chemical Peels for Acne and Acne Scars in Asians: Evidence Based Review

    PubMed Central

    Handog, Evangeline B; Datuin, Maria Suzanne L; Singzon, Ivan A

    2012-01-01

    Chemical peeling is a widely used procedure in the management of acne and acne scars, but there are very few studies on Asian populations who are more prone to develop hyper pigmentation. This article aims to summarize and evaluate the existing studies on the role of chemical peels in the treatment of acne and acne scars among Asians. An online search was conducted to identify prospective studies published in English that evaluated the use of chemical peels in active acne and acne scars in Asian populations. There were six studies for acne and eight studies for acne scars that were identified using our search parameters. Most were single-centre, open label and with small sample sizes. Acne severity was not uniformly reported and the objective outcome measures of some studies were not explicitly reported as well. The general trend of the results of the studies support the safety and efficacy of chemical peels for acne and acne scars including those of darker skin types. The existing studies support the use of chemical peels in the treatment of acne and acne scars in Asians. Further clinical trials with better study design and more subjects are needed to further establish the role of chemical peels in Asian acne patients. PMID:23378705

  7. 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.

  8. Drug discovery in pharmaceutical industry: productivity challenges and trends.

    PubMed

    Khanna, Ish

    2012-10-01

    Low productivity, rising R&D costs, dissipating proprietary products and dwindling pipelines are driving the pharmaceutical industry to unprecedented challenges and scrutiny. In this article I reflect on the current status of the pharmaceutical industry and reasons for continued low productivity. An emerging 'symbiotic model of innovation', that addresses underlying issues in drug failure and attempts to narrow gaps in current drug discovery processes, is discussed to boost productivity. The model emphasizes partnerships in innovation to deliver quality products in a cost-effective system. I also discuss diverse options to build a balanced research portfolio with higher potential for persistent delivery of drug molecules.

  9. Lymphocyte transformation in subjects with nodulo cystic acne.

    PubMed

    Puhvel, S M; Amirian, D; Weintraub, J; Reisner, R M

    1977-08-01

    Patients with severe nodulo-cystic acne are known to have elevated serum antibody levels and increased immediate hypersensitivity reactions to Propionibacterium acnes. This organism is the predominant bacterium in normal pilosebaceous follicles of human skin, and can be consistently isolated from pustular lesions in acne. Previously it had been observed that delayed cutaneous hypersensitivity reactions to P. acnes were negative in patients with acne. The present study investigated the proliferative response of lymphocytes from patients with nodulo-cystic acne to phytohaemagglutinin (PHA) and P. acnes antigen stimulation. The response to PHA stimulation was within normal limits. The response to P. acnes antigen showed a significant increase over control values obtained by testing lymphocytes from acne-free subjects. Thus cell mediated immunity to P. acnes may be present in subjects with severe inflammatory acne. These findings raise the possibility that reactions to P. acnes may contribute to intensifying the inflammatory response in acne lesions.

  10. Inhibitory effect of chlorophyllin on the Propionibacterium acnes-induced chemokine expression.

    PubMed

    Kang, Mi-Sun; Kim, Jin-Hee; Shin, Boo-Ahn; Lee, Hyun-Chul; Kim, Youn-Shin; Lim, Hae-Soon; Oh, Jong-Suk

    2013-12-01

    Chlorophyllin (CHL), a chlorophyll-derivative, exhibits several beneficial properties, including antibacterial, antioxidant, and anticancer activities. However, its antibacterial and anti-inflammatory activities against Propionibacterium acnes have not been described. The antibacterial activity of this compound was evaluated in vitro using the broth microdilution method. CHL had an inhibitory effect on the growth of P. acnes (MIC = 100 μM). In a real-time reverse transcription-polymerase chain reaction and an enzyme-linked immunosorbent assay, CHL significantly decreased interleukin-8 (IL-8) and monocyte chemoattractant protein-1 (MCP-1) production in a dose-dependent manner, decreasing both mRNA and protein levels for these chemokines in THP-1 cells indicating the anti-inflammatory effects of it. To investigate the molecular mechanisms underlying the anti-inflammatory properties of CHL in THP-1 cells stimulated by P. acnes, we used western blotting to analyze the effect of CHL on activation of the nuclear factor (NF)-κB. CHL inhibited P. acnes-induced IL-8 and MCP-1 production via blockade of NF-κB activation in THP-1 cells. Therefore, based on these results, we suggest that CHL is a useful agent to control the growth of P. acnes involved in acne inflammation and prevent acne.

  11. Androgen excess in cystic acne.

    PubMed

    Marynick, S P; Chakmakjian, Z H; McCaffree, D L; Herndon, J H

    1983-04-28

    We measured hormone levels in 59 women and 32 men with longstanding cystic acne resistant to conventional therapy. Affected women had higher serum levels of dehydroepiandrosterone sulfate, testosterone, and luteinizing hormone and lower levels of sex-hormone-binding globulin than controls. Affected men had higher levels of serum dehydroepiandrosterone sulfate and 17-hydroxyprogesterone and lower levels of sex-hormone-binding globulin than controls. To lower dehydroepiandrosterone sulfate, dexamethasone was given to men, and dexamethasone or an oral contraceptive pill, Demulen (or both), was given to women. Of the patients treated for six months, 97 per cent of the women and 81 per cent of the men had resolution or marked improvement in their acne. The dose of dexamethasone required to reduce dehydroepiandrosterone sulfate levels was low, rarely exceeding the equivalent of 20 mg of hydrocortisone per day. We conclude that most patients with therapeutically resistant cystic acne have androgen excess and that lowering elevated dehydroepiandrosterone sulfate results in improvement or remission of acne in most instances.

  12. 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 approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must... drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing... the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the...

  13. 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.

  14. Peptide synthesis beyond DMF: THF and ACN as excellent and friendlier alternatives.

    PubMed

    Jad, Yahya E; Acosta, Gerardo A; Khattab, Sherine N; de la Torre, Beatriz G; Govender, Thavendran; Kruger, Hendrik G; El-Faham, Ayman; Albericio, Fernando

    2015-02-28

    To date, DMF has been considered as the only solvent suitable for peptide synthesis. Here we demonstrate the capacity of THF and ACN, which are friendlier solvents than DMF, to yield the product in higher purity than DMF. Using various peptide models, both THF and ACN reduced racemization in solution-phase and solid-phase synthesis when compared with DMF. Moreover, the use of ACN and THF in the solid-phase peptide synthesis of hindered peptides, such as Aib-enkephalin pentapeptide and Aib-ACP decapeptide, in combination with a complete polyethylene glycol resin (ChemMatrix), gave a better coupling efficiency than DMF.

  15. 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.

  16. [Acne vulgaris in connection with the use of progestagens in a hormonal IUD or a subcutaneous implant].

    PubMed

    Cohen, E B; Rossen, N N

    2003-10-25

    Three women developed severe acne vulgaris within several weeks to a few months after either insertion of a levonorgestrel IUD (two women, 27 and 33 years of age) or subcutaneous implantation of an etonogestrel implant (26-year-old woman). The first woman had had acne previously; her IUD was removed and she was transferred to oral contraception with cyproterone-ethinyloestradiol. The second woman was treated with a peeling cream. The third woman changed to an oral anticonceptive and was treated with isotretinoin. The acne disappeared in all three patients. Progestagens have androgenic activity, even in low doses, and it is well known that androgenic stimulation of the sebaceous glands can cause acne vulgaris. The possibility that acne vulgaris may be an adverse reaction is probably not always considered. When asking the patient about her use of drugs, one should therefore ask specifically about an IUD or a subcutaneous implant.

  17. [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.

  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.

  19. 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

  20. 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

  1. 21 CFR 358.350 - Labeling of ingrown toenail relief 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 ingrown toenail relief drug products. 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 USE Ingrown Toenail Relief Drug Products...

  2. 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

  3. 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

  4. Acne vulgaris and rosacea: evaluation and management.

    PubMed

    Webster, G F

    2001-01-01

    Acne vulgaris, commonly termed acne, is an extremely common disease. It can be found in nearly all teenagers to some degree as well as in women in their 30s. Regardless of severity, acne often has a greater psychologic effect than cutaneous effect. Indeed, most patients overestimate the severity of their disease, while most physicians underestimate its impact on their patients. Studies have shown that people with severe acne as teens are less employable as adults and that self-esteem is low. When combined with other adolescent tensions, acne can be a difficult disease to treat. Rosacea, which usually starts in the late 20s, may affect the eyes as well as the skin. This article describes the pathogenesis of acne and rosacea and treatment approaches the primary care physician can use.

  5. Propionibacterium acnes: infection beyond the skin.

    PubMed

    Perry, Alexandra; Lambert, Peter

    2011-12-01

    Propionibacterium acnes is a Gram-positive bacterium that forms part of the normal flora of the skin, oral cavity, large intestine, the conjunctiva and the external ear canal. Although primarily recognized for its role in acne, P. acnes is an opportunistic pathogen, causing a range of postoperative and device-related infections. These include infections of the bones and joints, mouth, eye and brain. Device-related infections include those of joint prostheses, shunts and prosthetic heart valves. P. acnes may play a role in other conditions, including inflammation of the prostate leading to cancer, SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome, sarcoidosis and sciatica. If an active role in these conditions is established there are major implications for diagnosis, treatment and protection. Genome sequencing of the organism has provided an insight into the pathogenic potential and virulence of P. acnes.

  6. Isotretinoin therapy changes the expression of antimicrobial peptides in acne vulgaris.

    PubMed

    Borovaya, Alena; Dombrowski, Yvonne; Zwicker, Stephanie; Olisova, Olga; Ruzicka, Thomas; Wolf, Ronald; Schauber, Jürgen; Sárdy, Miklós

    2014-10-01

    In acne vulgaris, antimicrobial peptides (AMPs) could play a dual role; i.e., protective by acting against Propionibacterium acnes, pro-inflammatory by acting as signalling molecules. The cutaneous expression of 15 different AMPs was investigated in acne patients; furthermore, the impact of isotretinoin therapy on AMP expression was analysed in skin biopsies from 13 patients with acne vulgaris taken before, during and after a 6-month treatment cycle with isotretinoin using quantitative real-time polymerase chain reaction. Cutaneous expression of the AMPs cathelicidin, human β-defensin-2 (HBD-2), lactoferrin, lysozyme, psoriasin (S100A7), koebnerisin (S100A15), and RNase 7 was upregulated in untreated acne vulgaris, whereas α-defensin-1 (HNP-1) was downregulated compared to controls. While relative expression levels of cathelicidin, HBD-2, lactoferrin, psoriasin (S100A7), and koebnerisin (S100A15) decreased during isotretinoin treatment, only those of cathelicidin and koebnerisin returned to normal after 6 months of isotretinoin therapy. The increased expression of lysozyme and RNase 7 remained unaffected by isotretinoin treatment. The levels of granulysin, RANTES (CCL5), perforin, CXCL9, substance P, chromogranin B, and dermcidin were not regulated in untreated acne patients and isotretinoin had no effect on these AMPs. In conclusion, the expression of various AMPs is altered in acne vulgaris. Isotretinoin therapy normalizes the cutaneous production of distinct AMPs while the expression of others is still increased in healing acne. Considering the antimicrobial and pro-inflammatory role of AMPs, these molecules could serve as specific targets for acne therapy and maintenance of clinical remission.

  7. 21 CFR 347.50 - Labeling of skin protectant 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 skin protectant drug products. 347.50... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347.50 Labeling of skin protectant drug products. A skin protectant drug product may have more than...

  8. Prospects of Phage Application in the Treatment of Acne Caused by Propionibacterium acnes

    PubMed Central

    Jończyk-Matysiak, Ewa; Weber-Dąbrowska, Beata; Żaczek, Maciej; Międzybrodzki, Ryszard; Letkiewicz, Sławomir; Łusiak-Szelchowska, Marzanna; Górski, Andrzej

    2017-01-01

    Propionibacterium acnes is associated with purulent skin infections, and it poses a global problem for both patients and doctors. Acne vulgaris (acne) remains a problem due to its chronic character and difficulty of treatment, as well as its large impact on patients' quality of life. Due to the chronic course of the disease, treatment is long lasting, and often ineffective. Currently there are data regarding isolation of P. acnes phages, and there have been numerous studies on phage killing of P. acnes, but no data are available on phage application specifically in acne treatment. In this review, we have summarized the current knowledge on the phages active against P. acnes described so far and their potential application in the treatment of acne associated with P. acnes. The treatment of acne with phages may be important in order to reduce the overuse of antibiotics, which are currently the main acne treatment. However, more detailed studies are first needed to understand phage functioning in the skin microbiome and the possibility to use phages to combat P. acnes. PMID:28228751

  9. [Using combined magnetotherapy in patients with acne].

    PubMed

    Kul'chitskaia, D B; Orekhova, E M; Vasil'eva, E S

    2004-01-01

    Laser Doppler flowmetry discovered microcirculatory disorders in acne patients. Affected are arterioles as well as capillaries and venules. Combination of magnetotherapy with medication improves microcirculation in acne patients. More marked positive changes occurred in the microcirculatory system due to combined treatment compared to medication therapy only. Thus, laser Doppler flowmetry is a new, noninvasive method of assessing microcirculation in acne patients and can serve an objective criterion of treatment efficacy.

  10. Propionibacterium acnes infections in shoulder surgery.

    PubMed

    Horneff, John G; Hsu, Jason E; Huffman, G Russell

    2014-10-01

    Perioperative shoulder infections involving Propionibacterium acnes can be difficult to identify in a patient who presents with little more than pain and stiffness in the postoperative period. Although indolent in its growth and presentation, infection of the shoulder with P acnes can have devastating effects, including failure of the surgical intervention. This article reviews the importance of a comprehensive physical, radiologic, and laboratory evaluation, and discusses appropriate preventive and treatment strategies for P acnes infections of the shoulder.

  11. 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.

  12. Natural products as a foundation for drug discovery.

    PubMed

    Beutler, John A

    2009-09-01

    Natural products have provided chemical leads for the development of many drugs for diverse indications. While most U.S. pharmaceutical firms have reduced or eliminated their in-house natural product groups, there is a renewed interest in this source of new chemical entities. Many of the reasons for the past decline in popularity of natural products are being addressed by the development of new techniques for screening and production. The aim of this unit is to review current strategies and techniques that increase the value of natural products as a source for novel drug candidates.

  13. 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.

  14. Propionibacterium acnes infection after shoulder surgery

    PubMed Central

    Kadler, Benjamin K.; Mehta, Saurabh S.; Funk, Lennard

    2015-01-01

    Propionibacterium acnes has been implicated as a cause of infection following shoulder surgery, may occur up to 2 years after the index operation and has been shown to be responsible for up to 56% of shoulder infections after orthopedic implant. Male patients within the population undergoing shoulder surgery are particularly at risk, especially if their shoulder surgery involved prosthesis or was posttraumatic. P. acnes infection can be difficult to diagnose clinically and laboratory techniques require prolonged and specialized cultures. Usual inflammatory markers are not raised in infection with this low virulence organism. Delayed diagnosis with P. acnes infection can result in significant morbidity prior to prosthesis failure. Early diagnosis of P. acnes infection and appropriate treatment can improve clinical outcomes. It is important to be aware of P. acnes infection in shoulder surgery, to evaluate risk factors, to recognize the signs of P. acnes infection, and to promptly initiate treatment. The signs and symptoms of P. acnes infection are described and discussed. Data were collected from PubMed™, Web of Science, and the NICE Evidence Healthcare Databases - AMED (Ovid), BNI (Ovid), CINAHL (EBSCO), Embase (Ovid), HMIC: DH-Data and Kings Fund (Ovid), Medline (Ovid), and PsycINFO (Ovid). The search terms used were “P. acnes,” “infection,” “shoulder,” and “surgery.” In this review, we summarize the current understanding of the prevention and management of P. acnes infection following shoulder surgery. PMID:26622132

  15. 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...

  16. 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...

  17. 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...

  18. 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 product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  19. 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 product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  20. 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 product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  1. 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 product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  2. 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 product. (a) If a determination is made pursuant to § 1.750 that a patent for a human drug,...

  3. 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

  4. United States Food and Drug Administration Product Label Changes

    PubMed Central

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

    2017-01-01

    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:28367259

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

    PubMed

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

    2017-02-01

    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.

  6. 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.

  7. [Acne inversa in Crohn's disease].

    PubMed

    Goischke, H K; Ochsendorf, F R

    2001-11-01

    We report 2 patients with the association of Crohn's disease and acne inversa (= hidradenitis suppurativa). A 50-year-old woman with a 10-year-history of Crohn's disease developed suppurative nodules and abscesses in the genitoanal region. Over several years these lesions were hidden from everybody including the family physician. In a 42-year-old female patient abscesses appeared in the axilla 4 years after the diagnosis of Crohn's disease. During the next years these draining lesions also developed in both groins and the perineum. The differential diagnosis included cutaneous manifestations of Crohn's disease in both cases. The clinical picture with draining abscesses and sinuses with communicating channels, cystic nodules, hypertrophic scars and foul-smelling discharge were typical findings of acne inversa. In the last years this entity was reported several times in patients with Crohn's disease. Acne inversa starts with a compact hyperkeratosis of the infundibulum in terminal hair follicles, followed by a segmental rupture of the follicular epithelium and a spreading inflammatory reaction. As pathogenic factors genetic disposition and smoking were discussed. The only curative therapy is excision of the affected area. The reported association should be known in order to recognize the disease and institute the right therapy.

  8. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347... monohydrate identified in § 347.20(b). “For temporary relief of minor skin irritations due to: .” (2) For... witch hazel identified in § 347.12(c). “Relieves minor skin irritations due to: .” (c) Warnings....

  9. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347... monohydrate identified in § 347.20(b). “For temporary relief of minor skin irritations due to: .” (2) For... witch hazel identified in § 347.12(c). “Relieves minor skin irritations due to: .” (c) Warnings....

  10. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347... monohydrate identified in § 347.20(b). “For temporary relief of minor skin irritations due to: .” (2) For... witch hazel identified in § 347.12(c). “Relieves minor skin irritations due to: .” (c) Warnings....

  11. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347... monohydrate identified in § 347.20(b). “For temporary relief of minor skin irritations due to: .” (2) For... witch hazel identified in § 347.12(c). “Relieves minor skin irritations due to: .” (c) Warnings....

  12. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 347... monohydrate identified in § 347.20(b). “For temporary relief of minor skin irritations due to: .” (2) For... witch hazel identified in § 347.12(c). “Relieves minor skin irritations due to: .” (c) Warnings....

  13. Efficacy of a twice-daily, 3-step, over-the-counter skincare regimen for the treatment of acne vulgaris

    PubMed Central

    Rodan, Katie; Fields, Kathy; Falla, Timothy J

    2017-01-01

    Background Acne vulgaris (acne) is the most common skin disorder producing physical and emotional scars that can persist for years. An estimated 83% of acne sufferers self-treat, but there is lack of studies documenting the effectiveness of over-the-counter (OTC) acne treatment products. Objective This study was conducted to determine the effectiveness of an OTC, 3-step, anti-acne skincare regimen in treating acne and improving the appearance of red/inflamed facial skin. Methods This 6-week, open-label clinical study included both genders aged between 12 and 35 years with mild-to-moderate acne. All subjects were required to have an acne score of 1–3 (Cook’s acne grading scale: 0=clear to 7=very severe) and a moderate redness score of ≥2 (0=none and 4=severe). Subjects completed a 3-step facial treatment regimen every morning and evening using an OTC cleanser, toner, and acne treatment. Evaluations for effectiveness and safety were done at baseline and weeks 2, 4, and 6 using digital photographs (Visia-CR® digital imaging system) of the face and analyzed using Image-Pro® software for the grading of acne, red/inflamed skin, and the number and type of lesions. Results Thirty subjects (12 males and 18 females) were enrolled (mean age of 19 years; range 12–34 years). This skincare regimen resulted in statistically significant improvements in acne grading scores after 2 weeks of use, with mean scores continuing to improve after 4 and 6 weeks of use (P<0.001). Statistically significant improvements from baseline in red/inflamed skin, open and closed comedones, and papules were detected at all time points and for nodules at week 6, compared to their respective baselines (P<0.05). Conclusion This clinical study demonstrated the effectiveness of an OTC 3-step, anti-acne skincare regimen in significantly improving acne and the overall appearance of skin in the majority of subjects who had mild-to-moderate acne. PMID:28115862

  14. Selection of therapy for acne vulgaris: balancing concerns about antibiotic resistance.

    PubMed

    Del Rosso, James Q

    2008-11-01

    The widespread use of long-term antibiotics to treat acne and rosacea has resulted in increased Propionibacterium acnes resistance to antibiotics. Although resistance may decrease treatment effectiveness in some cases, it also is clear that antimicrobial activity is not the only role antibiotics play in acne management. The anti-inflammatory activity of antibiotics contributes to antipropionibacterial efficacy. In addition, the use of benzoyl peroxide (BPO) in combination with antibiotics to reduce resistant populations of propionibacteria is widely advocated, as P acnes has not developed resistance to it. P acnes now is known to form biofilms, which are bacterial communities that live encased in a glycocalyx polymer that aids in adherence to surfaces, thereby delaying antibiotic penetration. In addition to drug resistance, patient compliance with acne treatment is an important issue. Because compliance is a function of tolerability and convenience, new moisturizing noncomedogenic vehicles and fixed BPO-antibiotic combinations can be expected to improve compliance. Better efficacy has been noted with BPO-antibiotic combination therapy.

  15. 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

  16. [Feminine acne: dermatologic disease or endocrine disease?].

    PubMed

    Vexiau, P; Chivot, M

    2002-01-01

    Acne is a problem of the pilo-sebaceous follicle caused by the conjunction of three factors: seborrhea, follicle obstruction, and follicle inflammation. The key element, seborrhea, is under androgenic control. Acne in women is also influenced by developments and modifications in genital life, as well as by hormonal contraceptive and replacement therapies. Acne is rare prior to puberty, when it may indicate endocrine disease. At puberty, acne is quasi-physiological, because of the relative hyperandrogenism induced by the andrenarche preceding pubarche, as well as by the relative shortage of estrogens and progesterone during the first menstrual cycles. Other signs of hyperandrogenism, such as menstrual cycle difficulties and excess weight, which favor a hormonal origin, must be sought in cases of persistent or late-onset acne in adults. There is a mirror image of puberty during the peri-menopausal period, but with decreased seborrhea, so acne is rare. Finally, a tumoral origin must be sought in the rare cases of acne occurring after menopause. Hormonal investigation of acne should not be systematic, but is justified during prepuberty when other symptoms are associated with acne that resists well-conducted dermatological treatment. The therapeutic approach should be primarily dermatological, but hormone-oriented treatment should be considered when such therapy fails, or in the presence of other signs of hyperandrogenism. Sometimes the association of isotretinoin and an anti-androgen treatment are necessary to effectively treat such acne. Finally, particular attention must be paid to contraceptive therapies and hormone treatments, which can induce or aggravate acne, especially during the peri-menopausal period.

  17. Industrial natural product chemistry for drug discovery and development.

    PubMed

    Bauer, Armin; Brönstrup, Mark

    2014-01-01

    Covering: up to March 2013. In addition to their prominent role in basic biological and chemical research, natural products are a rich source of commercial products for the pharmaceutical and other industries. Industrial natural product chemistry is of fundamental importance for successful product development, as the vast majority (ca. 80%) of commercial drugs derived from natural products require synthetic efforts, either to enable economical access to bulk material, and/or to optimize drug properties through structural modifications. This review aims to illustrate issues on the pathway from lead to product, and how they have been successfully addressed by modern natural product chemistry. It is focused on natural products of current relevance that are, or are intended to be, used as pharmaceuticals.

  18. [Uncommon acne-associated syndromes and their significance in understanding the pathogenesis of acne].

    PubMed

    Hong, J-B; Prucha, H; Melnik, B; Ziai, M; Ring, J; Chen, W

    2013-04-01

    Acne is an intriguing model for the study of interactions between hormones, innate immunity, inflammation and wound healing (scarring). The manifestations and involvement of acne in different systemic diseases and some rare syndromes demonstrate its multifaceted nature. Synovitis-Acne-Pustulosis-Hyperostosis-Osteitis (SAPHO) and Pyogenic Arthritis-Pyoderma gangrenosum-Acne (PAPA) syndromes, both regarded as autoinflammatory diseases, highlight the attributes of inflammation in acne. While SAPHO syndrome can be used to explore the pathogenic role of Propionibacterium acnes in acne, PAPA syndrome and Apert syndrome can help understand the genetic influence on acne. The genetic defects in the gain-of-function of FGFR2 mutations in Apert syndrome and acne nevus of Munro lend further support to the hypothesis that the interaction of forkhead box class O (FoxOs)-mediated transcriptional regulation with androgen receptor transactivation and insulin/insulin like growth factor-1(IGF-1)-signaling is crucial in acne pathogenesis. Novel biologics, such as tumor necrosis factor (TNF) blockers and IL-1 inhibitors, appear promising in opposing the inflammation associated with SAPHO and PAPA syndromes, but it remains to seen if they can also improve severe acne particularly in the long term.

  19. Acne -- self-care

    MedlinePlus

    ... It may help to use a wash with salicylic acid or benzoyl if your skin is oily and ... products may contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid. They work by killing bacteria, drying up skin ...

  20. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 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....

  1. 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... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products....

  2. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 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....

  3. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 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....

  4. 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....

  5. 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.

  6. [Hormonal factors in etiology of common acne].

    PubMed

    Bergler-Czop, Beata; Brzezińska-Wcisło, Ligia

    2004-05-01

    Common acne is steatorrhoeic chronic disease, to which specific is, among others, the presence of blackheads, papulopustular eruptions, purulent cysts and cicatrices. Such hormonal factors belong to elements inherent in etiology of the affection. Sebaceous glands have cell receptors on their surface for androgens. In etiopathogenesis of common/simple acne, a decisive role is played by a derivative of testosterone, i.e. 5-alpha-dihydrotestosterone (DHT). However, some experts are of opinion that there is no correlation between the increased intensity of common acne and other symptoms of hyperandrogenism. Numerous authors assume, however, that common acne-affected patients may be sometimes subjected to intense reactions caused by sebaceous glands against physiological androgens concentrations. Naturally, estrogens can inhibit release of such androgens. Under physiological conditions, natural progesterone does not conduct to intensification of the seborrhea, but the activity of sebum secretion may be triggered off by its synthetic counterparts. Hormonal etiology can be very distinctly visible in the steroid, androgenic, premenstrual, menopausal acne, as well as in juvenile acne and acne neonatorum. In case of females affected by acne, hormonal therapy should be persistently supported and consulted with dermatologists, endocrinologists and gynecologists. Antiandrogenic preparations are applied, such as: cyproterone acetate concurrently administered with estrogens and, as well as not so frequently with chlormadinone acetate (independently or during estrogenic therapy).

  7. Clinical markers of androgenicity in acne vulgaris.

    PubMed

    Sheehan-Dare, R A; Hughes, B R; Cunliffe, W J

    1988-12-01

    Androgenic stimulation of sebaceous glands is necessary for development of acne. If hyperandrogenaemia were a major determinant of acne in women, the frequency of other clinical markers of androgenicity should increase with acne severity. To investigate this, 268 female subjects (aged 12-44 years) were studied. Subjects were divided into groups on the basis of acne severity: physiological, moderate, and severe. With exclusion of women taking oral contraceptives or anti-androgen therapy, subjects in each group were similar with respect to age at menarche and incidence of menstrual irregularity of amenorrhoea. Reports of excessive body hair, and clinical hirsutes on examination were few and there were no significant differences between acne severity groups. No correlation was observed between acne and hirsutes grades in all subjects (rank correlation coefficient = 0.096). Mild male pattern androgenic alopecia occurred in similar proportions of subjects in the three groups. Female pattern androgenic alopecia was observed in only two subjects. We have shown no correlation between acne severity and clinical markers of androgenicity in women. This suggests that in most cases factors other than hyperandrogenaemia are necessary for the development of acne.

  8. Nano-sized crystalline drug production by milling technology.

    PubMed

    Moribe, Kunikazu; Ueda, Keisuke; Limwikrant, Waree; Higashi, Kenjirou; Yamamoto, Keiji

    2013-01-01

    Nano-formulation of poorly water-soluble drugs has been developed to enhance drug dissolution. In this review, we introduce nano-milling technology described in recently published papers. Factors affecting the size of drug crystals are compared based on the preparation methods and drug and excipient types. A top-down approach using the comminution process is a method conventionally used to prepare crystalline drug nanoparticles. Wet milling using media is well studied and several wet-milled drug formulations are now on the market. Several trials on drug nanosuspension preparation using different apparatuses, materials, and conditions have been reported. Wet milling using a high-pressure homogenizer is another alternative to preparing production-scale drug nanosuspensions. Dry milling is a simple method of preparing a solid-state drug nano-formulation. The effect of size on the dissolution of a drug from nanoparticles is an area of fundamental research, but it is sometimes incorrectly evaluated. Here, we discuss evaluation procedures and the associated problems. Lastly, the importance of quality control, process optimization, and physicochemical characterization are briefly discussed.

  9. 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

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. 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

  17. 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

  18. Cedarwood Oil as Complementary Treatment in Refractory Acne.

    PubMed

    Hassoun, Lauren A; Ornelas, Jennifer N; Sivamani, Raja K

    2016-03-01

    Acne vulgaris is a widely prevalent chronic skin disease. Although multiple treatments are available, acne can sometimes be refractory to these treatments. The use of alternative medical therapies has increased within dermatology and for acne. This case report describes a patient in whom the addition of cedarwood oil was helpful in controlling acne.

  19. 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

    ... fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan. Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated...

  20. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan. Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated...

  1. 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

    ... fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan. Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated...

  2. 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

  3. Recently approved systemic therapies for acne vulgaris and rosacea.

    PubMed

    Del Rosso, James Q

    2007-08-01

    Until recently, with the exception of oral isotretinoin for the treatment of severe recalcitrant nodular acne, systemic therapy for acne vulgaris and rosacea has been based on anecdotal support, clinical experience, and small clinical trials. Tetracycline derivatives are the predominant systemic agents that have been used for both disease states, prescribed in dose ranges that produce antibiotic activity. Anti-inflammatory dose doxycycline, a controlled-release (CR) 40-mg capsule formulation of doxycycline that is devoid of antibiotic activity when administered once daily, was US Food and Drug Administration (FDA)-approved for the treatment of inflammatory lesions (papules and pustules) of rosacea, based on large-scale phase 3 pivotal trials and long-term microbiologic and safety data. Also, an extended-release (ER) tablet formulation of minocycline was approved by the FDA for the treatment of inflammatory lesions of moderate to severe acne vulgaris in patients 12 years and older based on large-scale phase 3 clinical trials that evaluated efficacy and safety, dose-response analysis, and long-term data. This article discusses the studies and clinical applications related to the use of these agents.

  4. The use of sodium sulfacetamide 10%-sulfur 5% emollient foam in the treatment of acne vulgaris.

    PubMed

    Del Rosso, James Q

    2009-08-01

    Acne vulgaris is the most common disorder encountered in ambulatory clinical practice comprising 11.3 percent of office visits to dermatologists in 2005.(1) By comparison, eczematous dermatoses, psoriasis, and skin cancer accounted for 6.2, 3.5, and 10 percent of office visits, respectively.(1) A variety of topical therapeutic options are available for treatment of acne vulgaris, including benzoyl peroxide, antibiotics, retinoids, azelaic acid, and sodium sulfacetamide-sulfur.(2,3) Sodium sulfacetamide 10%-sulfur 5% has been used for the topical treatment of seborrheic dermatitis, acne vulgaris, and rosacea since the mid-1950s and is available in a variety of formulations, including lotions, creams, cleansers, and emollient foams.(4) Recently, an emollient foam sodium sulfacetamide 10%-sulfur 5% formulation indicated for topical therapy of acne vulgaris, rosacea, and seborrheic dermatitis has become available.(5) This article provides an overview of the sodium sulfacetamide 10%-sulfur 5% emollient foam and reports the results of a case report series of patients with acne vulgaris treated with sodium sulfacetamide 10%-sulfur 5% emollient foam as monotherapy or in combination with other topical acne products.

  5. 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

    2016-07-08

    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.

  6. 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 ADMINISTRATION, DEPARTMENT OF JUSTICE RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES §...

  7. 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 ADMINISTRATION, DEPARTMENT OF JUSTICE RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES §...

  8. 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 ADMINISTRATION, DEPARTMENT OF JUSTICE RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES §...

  9. 76 FR 16533 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 Animal Drugs, Feeds, and Related Products... medicated feed. This correction is being made to improve the accuracy of the animal drug regulations. DATES... removing cross references for use of the withdrawn drugs in combination ] drug medicated feed....

  10. 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...

  11. Marine natural products: a way to new drugs.

    PubMed

    Stonik, V A

    2009-07-01

    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.

  12. 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

  13. 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...

  14. 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...

  15. 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... 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...

  16. 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...

  17. 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...

  18. Aczone, a topical gel formulation of the antibacterial, anti-inflammatory dapsone for the treatment of acne.

    PubMed

    Scheinfeld, Noah

    2009-05-01

    Allergen Inc has launched Aczone, a topical gel formulation of the antibacterial, anti-inflammatory agent dapsone, for the potential treatment of acne vulgaris. Oral dapsone has demonstrated efficacy in acne, but was associated with severe side effects such as anemia, which was particularly serious in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Aczone was developed to overcome this limitation, and is formulated using solvent-microparticle technology for improved absorption and action and for fewer side effects. In a phase I clinical trial, systemic exposure to dapsone was 126-fold lower following treatment with Aczone compared with oral dapsone. Aczone significantly reduced lesion counts in patients with acne in phase III trials, and was particularly effective in reducing inflammatory lesions. In a phase IV trial, Aczone was safely applied to patients with G6PD deficiency without inducing anemia. Phase IV trials in patients with acne were ongoing at the time of publication to assess safety and to compare Aczone monotherapy with combinations of Aczone and other anti-acne therapeutics. At the time of publication, Allergen was also developing Aczone for the treatment of rosacea; the drug was undergoing phase II trials for this indication. Aczone appears to be a novel promising anti-acne therapeutic option, particularly for patients with inflammatory acne.

  19. 21 CFR 341.74 - Labeling of antitussive drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.” (2) “Temporarily...,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants... (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  20. 21 CFR 341.74 - Labeling of antitussive drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.” (2) “Temporarily...,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants... (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  1. 21 CFR 341.74 - Labeling of antitussive drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.” (2) “Temporarily...,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants... (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  2. 21 CFR 341.74 - Labeling of antitussive drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.” (2) “Temporarily...,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants... (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  3. 21 CFR 341.74 - Labeling of antitussive drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...”) (select one of the following: “A cold” or “the common cold”) “or inhaled irritants.” (2) “Temporarily...,” or “occurring with”) (select one of the following: “A cold,” “the common cold,” or “inhaled irritants... (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS...

  4. 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.)

  5. Pregnane X receptor and natural products: beyond drug-drug interactions.

    PubMed

    Staudinger, Jeff L; Ding, Xunshan; Lichti, Kristin

    2006-12-01

    The pregnane X receptor (PXR, NR1I2) is a member of the nuclear receptor superfamily that is activated by a myriad of compounds and natural products in clinical use. Activation of PXR represents the basis for several clinically important drug-drug interactions. Although PXR activation has undesirable effects in patients on combination therapy, it also mediates the hepatoprotective effects exhibited by some herbal remedies. This review focuses on PXR activation by natural products and the potential therapeutic opportunities presented. In particular, the biological effects of St. John's Wort, gugulipid, kava kava, Coleus forskolii, Hypoxis, Sutherlandia, qing hao, wu wei zi, gan cao and other natural products are discussed. The impact of these natural products on drug metabolism and hepatoprotection is highlighted in the context of activation and antagonism of PXR.

  6. [Hormonal assessment in a woman with acne and alopecia].

    PubMed

    Faure, M; Drapier-Faure, E

    1992-06-01

    Acne, androgenogenetic alopecia, hyperseborrhea and hirsutism may result from hyperandrogenism in women. This may be peripheral "idiopathic" hyperandrogenism due to cutaneous metabolism of steroids, but in some cases hyperandrogenism is due to abnormal production or input of steroids with androgenic activity (hyperplasia, endocrine tumors, cysts, consumption of progestogens or other hormones with androgenic activity, menopause...). An assessment is useful only in cases of acne or alopecia if they are accompanied by other signs of peripheral hyperandrogenism and/or disturbed menstruation. The treatment is based on the administration of an anti-androgen (in France, usually cyproterone acetate), combined with other local or systemic treatments for the problem, depending on the age, dermatological signs and context.

  7. 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

  8. 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...

  9. 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

  10. ACNE VULGARIS TREATMENT : THE CURRENT SCENARIO

    PubMed Central

    Rathi, Sanjay K

    2011-01-01

    Acne Vulgaris is one of the most common skin disorders which dermatologists have to treat. It mainly affect adolescent, though may present at any age. In recent years, due to better understanding of the pathogenesis of acne, new therapeutic modalities and various permutation and combinations have been designed. In topical agents; benzoyl peroxide, antibiotics, retinoids, etc are the mainstay of treatment; can be given in combinations. While systemic therapy includes oral antibiotics, hormonal therapy, and isotretinoin, depending upon the need of patients it has to be selected. Physical treatment in the form of lesion removal, photo-therapy is also helpful in few of them. Since various old and new topical and systemic agents are available to treat acne, it sometime confuse treating dermatologist. To overcome this, panel of physicians and researchers worked together as a global alliance and task force to improve outcomes in acne treatment. They have tried to give consensus recommendation for the treatment of acne. Successful management of acne needs careful selection of anti-acne agents according to clinical presentation and individual patient needs. PMID:21572783

  11. 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.

  12. 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... 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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... SERVICES (CONTINUED) DRUGS FOR HUMAN USE EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 348.50 Labeling of external analgesic drug products. (a) Statement of identity. The labeling...

  18. 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 Drugs Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for...

  19. Acne image analysis: lesion localization and classification

    NASA Astrophysics Data System (ADS)

    Abas, Fazly Salleh; Kaffenberger, Benjamin; Bikowski, Joseph; Gurcan, Metin N.

    2016-03-01

    Acne is a common skin condition present predominantly in the adolescent population, but may continue into adulthood. Scarring occurs commonly as a sequel to severe inflammatory acne. The presence of acne and resultant scars are more than cosmetic, with a significant potential to alter quality of life and even job prospects. The psychosocial effects of acne and scars can be disturbing and may be a risk factor for serious psychological concerns. Treatment efficacy is generally determined based on an invalidated gestalt by the physician and patient. However, the validated assessment of acne can be challenging and time consuming. Acne can be classified into several morphologies including closed comedones (whiteheads), open comedones (blackheads), papules, pustules, cysts (nodules) and scars. For a validated assessment, the different morphologies need to be counted independently, a method that is far too time consuming considering the limited time available for a consultation. However, it is practical to record and analyze images since dermatologists can validate the severity of acne within seconds after uploading an image. This paper covers the processes of region-ofinterest determination using entropy-based filtering and thresholding as well acne lesion feature extraction. Feature extraction methods using discrete wavelet frames and gray-level co-occurence matrix were presented and their effectiveness in separating the six major acne lesion classes were discussed. Several classifiers were used to test the extracted features. Correct classification accuracy as high as 85.5% was achieved using the binary classification tree with fourteen principle components used as descriptors. Further studies are underway to further improve the algorithm performance and validate it on a larger database.

  20. Acne and risk of prostate cancer.

    PubMed

    Sutcliffe, Siobhan; Giovannucci, Edward; Isaacs, William B; Willett, Walter C; Platz, Elizabeth A

    2007-12-15

    In a recent study, prostatectomy specimens from which Propionibacterium acnes was cultured were more likely to have inflammation than culture-negative specimens or specimens positive for other bacteria, leading the authors to hypothesize that P. acnes-mediated inflammation may contribute to prostate carcinogenesis. To indirectly explore associations between P. acnes and prostate cancer, we investigated severe acne, as measured by tetracycline use for 4 or more years, in relation to incident prostate cancer in the Health Professionals Follow-up Study. On the 1992 follow-up questionnaire, participants were asked whether they had ever used "tetracycline for at least 2 months at a time (e.g., for acne or other reason)" and their duration of use. Prostate cancer diagnoses were ascertained on each subsequent biennial questionnaire and confirmed by medical record review. Between 1992 and 2002, 2,147 cases of prostate cancer were reported among 34,629 eligible participants. Men who used tetracycline for 4 or more years had a significantly higher risk of prostate cancer (16 cases, 1,569 person-years) than men who did not use tetracycline (2,071 cases, 304,822 person-years, multivariable-adjusted RR = 1.70, 95% CI: 1.03-2.80). Although intriguing, this finding should be viewed cautiously because of the small number of exposed cases, indirect assessment of severe acne, and complex etiology of acne, which is not limited to P. acnes infection. Therefore, additional biologic and epidemiologic studies are necessary to determine and elucidate the possible role of P. acnes infection in prostate carcinogenesis.

  1. Treatment of preadolescent acne in the United States: an analysis of nationally representative data.

    PubMed

    Davis, Scott A; Sandoval, Laura F; Gustafson, Cheryl J; Feldman, Steven R; Cordoro, Kelly M

    2013-01-01

    The prevalence of acne in younger children is increasing. Of the acne treatments that the U.S. Food and Drug Administration (FDA) has approved for ages 12 years and older, it is unclear which medications are being prescribed off-label for this younger patient population. The purpose of this study is to compare the therapies being prescribed to preadolescent patients with acne (defined in this study as ages 7 to 11 years) with those being prescribed to adolescent patients (ages 12 to 18 years) and to determine whether prescribing patterns differ between dermatologists and pediatricians. Leading therapies for the treatment of children with a diagnosis of acne were collected from the National Ambulatory Medical Care Survey (NAMCS) from 1993 to 2009. Data were stratified according to age group and physician specialty. Physicians prescribed a wide variety of FDA-approved and off-label medications to preadolescent patients with acne. The leading medications were topical treatments, including adapalene (14.4%), benzoyl peroxide (12.8%), and tretinoin (12.5%). Treatment of this age group differed substantially between specialties, with dermatologists frequently prescribing topical retinoids and primary care physicians preferring antibiotics, particularly oral antibiotics. Limitations included a lack of data on acne severity and morphology through NAMCS, as well as the absence of longitudinal data. With the limited number of FDA-approved treatment options, off-label prescribing for acne in preadolescent patients is common. Furthermore, this study identified a potential knowledge gap between pediatricians based on their prescribing patterns in this patient population.

  2. [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

  3. 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

  4. 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

  5. Propionibacterium acnes strain populations in the human skin microbiome associated with acne.

    PubMed

    Fitz-Gibbon, Sorel; Tomida, Shuta; Chiu, Bor-Han; Nguyen, Lin; Du, Christine; Liu, Minghsun; Elashoff, David; Erfe, Marie C; Loncaric, Anya; Kim, Jenny; Modlin, Robert L; Miller, Jeff F; Sodergren, Erica; Craft, Noah; Weinstock, George M; Li, Huiying

    2013-09-01

    The human skin microbiome has important roles in skin health and disease. However, bacterial population structure and diversity at the strain level is poorly understood. We compared the skin microbiome at the strain level and genome level of Propionibacterium acnes, a dominant skin commensal, between 49 acne patients and 52 healthy individuals by sampling the pilosebaceous units on their noses. Metagenomic analysis demonstrated that although the relative abundances of P. acnes were similar, the strain population structures were significantly different in the two cohorts. Certain strains were highly associated with acne, and other strains were enriched in healthy skin. By sequencing 66 previously unreported P. acnes strains and comparing 71 P. acnes genomes, we identified potential genetic determinants of various P. acnes strains in association with acne or health. Our analysis suggests that acquired DNA sequences and bacterial immune elements may have roles in determining virulence properties of P. acnes strains, and some could be future targets for therapeutic interventions. This study demonstrates a previously unreported paradigm of commensal strain populations that could explain the pathogenesis of human diseases. It underscores the importance of strain-level analysis of the human microbiome to define the role of commensals in health and disease.

  6. Laser and light-based treatments of acne and acne scarring.

    PubMed

    Alexiades, Macrene

    The treatment of acne and acne scarring with lasers and light-based and energy-based technologies has become an integral component of our therapeutic arsenal. Lasers including infrared wavelengths and pulsed dye lasers; light devices including blue light, red light, and broadband light; and photodynamic therapy with aminolevulinic acid and methylaminolevulinic acid have been shown to be effective in the treatment of acne vulgaris. The optimal outcomes are achieved with photodynamic therapy combined with medical therapy. Acne scarring has been best treated with lasers, including nonablative infrared lasers, fractional nonablative and ablative laser resurfacing, and most recently needle-based radiofrequency devices.

  7. Papular Acne Scars of the Nose and Chin: An Under-recognised Variant of Acne Scarring

    PubMed Central

    Ali, Faisal R; Kirk, Michael; Madan, Vishal

    2016-01-01

    Background: Scarring following acne vulgaris is common and can be of profound psychosocial consequence. Aims and Objectives: We have clinically noted a variant of acne scarring, overlooked by previous categorisation schemes, which we have denominated as papular acne scars of the nose and chin. We sought to characterise these novel entities further. Materials and Methods: Initially, we identified 14 patients with papular acne scars of the nose and chin in a cosmetic dermatology clinic, of whom two were female and rest were male. We then prospectively evaluated 100 consecutive patients attending our tertiary referral acne isotretinoin clinic and 49 patients attending a general dermatology clinic. Results: Amongst 149 patients, from a general dermatology and tertiary acne clinic, soft papular scars were noted in four patients, distributed on the nose and chin. Three of the four patients were male, three patients had additional acne scars and the median age was 23.5. Conclusions: We have identified 18 patients with papular acne scars of the nose and chin and propose that this new category should be added to acne scarring classification schemes. Future work should be directed at corroborating the epidemiology of such lesions and describing effective treatment modalities. PMID:28163455

  8. 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.

  9. 21 CFR 358.550 - Labeling of corn and callus remover 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 corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug products... any, and identifies the product as a “corn and callus remover.” (b) Indications. The labeling of...

  10. 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... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug products... any, and identifies the product as a “corn and callus remover.” (b) Indications. The labeling of...

  11. 21 CFR 358.550 - Labeling of corn and callus remover 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 corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug products... any, and identifies the product as a “corn and callus remover.” (b) Indications. The labeling of...

  12. 21 CFR 358.550 - Labeling of corn and callus remover 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 corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug products... any, and identifies the product as a “corn and callus remover.” (b) Indications. The labeling of...

  13. 21 CFR 358.550 - Labeling of corn and callus remover 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 corn and callus remover drug products... USE Corn and Callus Remover Drug Products § 358.550 Labeling of corn and callus remover drug products... any, and identifies the product as a “corn and callus remover.” (b) Indications. The labeling of...

  14. 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.”...

  15. 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.”...

  16. 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.”...

  17. 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

  18. [New drugs for horses and production animals in 2013].

    PubMed

    Emmerich, I U

    2014-01-01

    In 2013, only one newly developed active pharmaceutical ingredient for horses and food-producing animals was released on the German market for veterinary drug products. The ionophore monensin from the group of polyether antibiotics is now available as an orally administered continuous release intraruminal device for cattle (Kexxtone®). Furthermore, two established veterinary active pharmaceutical ingredients are available for additional species: The antibiotic amoxicillin (Suramox®) is also authorized for ducks and turkeys and the dissociative anesthetic ketamine is now authorized for sheep, goats and dairy cattle. Additionally, one veterinary drug with a new pharmaceutical form as well as one product with a new strength have been launched on the market for veterinary drugs for horses and food producing animals.

  19. Cultural characteristics and fatty acid composition of Corynebacterium acnes.

    PubMed

    Moss, C W; Dowell, V R; Lewis, V J; Schekter, M A

    1967-11-01

    A detailed study of the cultural characteristics and cellular fatty acid composition of 27 isolates of Corynebacterium acnes was performed to establish the properties by which this organism may be identified and characterized. The fatty acids were extracted directly from whole cells and examined as methyl esters by gas-liquid chromatography. Each strain possessed a similar fatty acid profile which was characterized by a large percentage of C15 branched-chain acid. Uniformity in certain biochemical reactions and cultural characteristics was also observed. All strains were catalase-positive, nonmotile, and urease-negative, reduced nitrate, liquefied gelatin, failed to hydrolyze esculin and starch, and gave a positive methyl red test. Glucose, fructose, and glycerol were fermented, but not lactose, salicin, sucrose, maltose, xylose, or arabinose. Production of hydrogen sulfide and indole, fermentation of mannitol, and hemolytic activity were variable characteristics. Two species of the genus Propionibacterium were also tested and found to be similar to C. acnes both in cultural characteristics and fatty acid composition. The results strengthen previous suggestions that C. acnes should be classified in the genus Propionibacterium.

  20. 21 CFR 357.150 - Labeling of anthelmintic drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” (d) Directions. The labeling of... Do not use unless directed by a doctor. 25 to 37 pounds 125 milligrams. 38 to 62 pounds...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” (d) Directions. The labeling of... Do not use unless directed by a doctor. 25 to 37 pounds 125 milligrams. 38 to 62 pounds...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” (d) Directions. The labeling of... Do not use unless directed by a doctor. 25 to 37 pounds 125 milligrams. 38 to 62 pounds...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” (d) Directions. The labeling of... Do not use unless directed by a doctor. 25 to 37 pounds 125 milligrams. 38 to 62 pounds...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... taking this drug. If any of these conditions persist consult a doctor.” (2) “If you are pregnant or have liver disease, do not take this product unless directed by a doctor.” (d) Directions. The labeling of... Do not use unless directed by a doctor. 25 to 37 pounds 125 milligrams. 38 to 62 pounds...

  5. A New Golden Age of Natural Products Drug Discovery

    PubMed Central

    Shen, Ben

    2016-01-01

    The 2015 Nobel Prize in Physiology or Medicine has been awarded to William C. Campbell and Satoshi Omura, and Youyou Tu for the discovery of avermectins and artemisinin, respectively, therapies that revolutionized the treatment of devastating parasite diseases. With the recent technological advances, a New Golden Age of natural products drug discovery is dawning. PMID:26638061

  6. 21 CFR 341.76 - Labeling of bronchodilator drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression... product, but seek medical assistance immediately if symptoms are not relieved within 1 hour or become... loss of appetite. If these symptoms persist or become worse, consult your doctor.” (6) For...

  7. 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

  8. New perspectives on antiacne plant drugs: contribution to modern therapeutics.

    PubMed

    Sinha, Priyam; Srivastava, Shruti; Mishra, Nidhi; 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.

  9. Clinical practice guidelines for treatment of acne vulgaris: a critical appraisal using the AGREE II instrument.

    PubMed

    Sanclemente, Gloria; Acosta, Jorge-Luis; Tamayo, Maria-Eulalia; Bonfill, Xavier; Alonso-Coello, Pablo

    2014-04-01

    A significant number of clinical practice guidelines (CPGs) about the treatment of acne vulgaris in adolescents and adults have been published worldwide. However, little is known about the quality of CPGs in this field. The aim of this study was to appraise the methodological quality of published acne vulgaris CPGs. We performed a systematic review of published CPGs on acne vulgaris therapy from July 2002 to July 2012. Three reviewers independently assessed each CPG using the AGREE II instrument. A standardized score was calculated for each of the six domains. Our search strategy identified 103 citations but just six met our inclusion criteria. Agreement among reviewers was very good: 0.981. The domains that scored better were: "scope and purpose" and "clarity and presentation". Those that scored worse were "stakeholder involvement", "rigor of development", and "applicability". The European and the Malaysian CPGs were the only recommended with no further modifications. In addition, the Mexican, Colombian and the United States guidelines were recommended with provisos, with lower scores regarding stakeholder involvement, rigor of development and applicability. Only two guidelines clearly reported outcome measures for evaluating efficacy or included quality of life outcomes. CPGs varied regarding the consideration of light/laser therapy or consideration of complementary/alternative medicines. None of them included cost considerations of drugs such as systemic isotretinoin. In conclusion, published acne vulgaris CPGs for acne therapy vary in quality with a clear need to improve their methodological rigor. This could be achieved with the adherence to current CPGs development standards.

  10. 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.

  11. A Topical Medication of All-Trans Retinoic Acid Reduces Sebum Excretion Rate in Patients With Forehead Acne.

    PubMed

    Pan, Jing; Wang, Qian; Tu, Ping

    2016-02-11

    Acne is a disease of the hair follicles of the face, chest, and back that affects almost all teenagers during puberty. This study is conducted to investigate if all-trans retinoic acid (ATRA) could reduce sebum excretion rate (SER) in acne patients by influencing content of skin-surface lipid production. Thirty-nine patients with forehead acne were topically treated with cream base (vehicle) and 0.025% ATRA cream once a night for 7 days. Separation and identification of sebum production collected from the skin on the acne were performed using thin-layer chromatography. SER was calculated according to the total amount of individual sebum productions that were quantified by using Alphaimager IS-2200 imaging analysis. Our data showed that the value of SER on the acne-affected skin was significantly decreased in the ATRA-treated patients as compared with ones treated with vehicle (P < 0.01). Treatment with ATRA resulted in inducing significant decreases in the contents of wax esters (WE), triglycerides and fatty acids, and free fatty acids (FFA) productions (all P < 0.01). In further analysis, the changes in the data before and after treatments with vehicle and ATRA were compared with significant differences exhibited in the values of SER, WE, and FFA (all P < 0.05). This study indicates that the topical application of ATRA in treatment of acne patients induces decrease in SER by inhibiting the excretion of WE and FFA productions.

  12. 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.

  13. Natural Acne Treatment: What's Most Effective?

    MedlinePlus

    ... be helpful in reducing acne inflammation and breakouts: Tea tree oil. Gels containing 5 percent tea tree oil may be as effective as are lotions containing 5 percent benzoyl peroxide, although tea tree oil might work more slowly. Possible side ...

  14. 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.

  15. New antibiotic therapies for acne and rosacea.

    PubMed

    Mays, Rana Majd; Gordon, Rachel A; Wilson, Janice M; Silapunt, Sirunya

    2012-01-01

    Acne and rosacea compromise a substantial portion of the dermatology clinical practice. Over the past century, many treatment modalities have been introduced with antibiotics playing a major role. Today, both oral and topical antibiotics are used in the management of acne and rosacea, with several novel formulations and/or combination regimens recently introduced. The latest studies suggest anti-inflammatory actions to be the most likely mechanism of antibiotics in acne and rosacea, shifting the focus to subantimicrobial-dose oral antibiotics and/or topical antibiotic regimens as the preferred first-line agents. Here we will discuss the most recent oral and topical antibiotic therapies available for treatment of acne and rosacea, with special focus on efficacy data, indication, dosing, and mechanism of action.

  16. Subantimicrobial dose doxycycline for acne and rosacea.

    PubMed

    Bikowski, Joseph B

    2003-01-01

    Acne vulgaris and rosacea present therapeutic challenges due to their chronicity, potential for disfigurement, and psychosocial impact. Although pathophysiologically distinct, both conditions have major inflammatory components. Consequently, topical and systemic antimicrobial agents are routinely prescribed for extended periods. Emergence of resistant strains of Propionibacterium acnes, adverse events, and compliance issues associated with chronic systemic tetracycline use have led to new treatment approaches. At subantimicrobial doses, tetracyclines reduce inflammation via anticollagenolytic, antimatrix-degrading metalloproteinase, and cytokine down-regulating properties. Subantimicrobial dose (SD) doxycycline (Periostat 20 mg) has clinical utility in periodontitis and has been investigated in a double-blind, placebo-controlled trial in the treatment of moderate facial acne as well as in an open label study in the treatment of rosacea. The results of subantimicrobial dose doxycycline treatment in early trials support its benefits and further investigation in acne and rosacea.

  17. [The pathogenesis of acne vulgaris (author's transl)].

    PubMed

    Gloor, M; Habedank, W D

    1976-05-14

    Stickl's method of oral treatment of acne vulgaris with antigens has been carried out on 26 test persons. During the treatment the number of comedones increased significantly and the number of papules decreased significantly. Biochemically, a significant increase of the free fatty acids and a significant decrease of the triglycerides could be demonstrated in the skin surface lipids, the total amount remaining unchanged. The following important conclusions for the pathogenesis of acne may be drawn: 1. The living conditions for Corynebacterium acnes on the surface of the skin or in the ducts of sebaceous glands respectively are influenced by the immunological system of the host. 2. The free fatty acids have a comedogenic effect in vivo. 3. The free fatty acids are not responsible for the development of inflammatory acne efflorescences.

  18. DERMABRASIVE ABLATION OF ACNE SCARS

    PubMed Central

    Brown, Adolph M.

    1958-01-01

    Dermabrasion offers cosmetic improvement of acne pits and scars, but only well-adjusted patients should be selected for this esthetic improvement. In the dermabrasion operation the deep cup-shaped pits are made shallow by saucerization, for the deep sharp shadows are eliminated as the pits are shallowed. It is the elimination of the shadow effect which is so gratifying to the patient. Although dermabrasion is a superficial skin operation, it involves dangerous instruments and thousands of minute incisions. The procedure is a surgical operation, whether done in an office or in a hospital. The author performs the operation entirely as a hospital procedure, using pentothal anesthesia with meperidine added in small increments during the operation. Thus the operation may be unhurriedly and meticulously performed. ImagesFigure 1.Figure 2. PMID:13561125

  19. Acne

    MedlinePlus

    ... can lead to the development of scars or dark blotches. Shave Carefully Test both electric and safety ... people learn more about clinical trials, why they matter, and how to participate. Visitors to the website ...

  20. 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

  1. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and...

  2. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and... amending the animal drug regulations by removing those portions that reflect approval of two new...

  3. Acne: Kids are not just little people.

    PubMed

    Que, Syril Keena T; Whitaker-Worth, Diane L; Chang, Mary Wu

    Acne vulgaris is a common inflammatory disease of the pilosebaceous follicles that affects patients of all ages, from neonates to adults. We have compared and contrasted the clinical presentation of acne in neonates, infants, children, teenagers, and young adults and review the scenarios in which further systemic endocrine or hormonal tests are indicated. We also discuss age-dependent treatment considerations, including appropriate oral antimicrobial regimens and the proper dosing of isotretinoin in young children versus teenagers and adults.

  4. Estimating product bioequivalence for highly variable veterinary drugs.

    PubMed

    Claxton, R; Cook, J; Endrenyi, L; Lucas, A; Martinez, M N; Sutton, S C

    2012-04-01

    The occurrence of drugs and drug formulations associated with large intrasubject pharmacokinetic (PK) variability has been well described in humans and is likewise encountered in veterinary medicine. The scaled average bioequivalence (SABE) approach adopted by CDER of the FDA for the determination of bioequivalence (BE) of highly variable drugs (HVD) needs to be considered when applied to veterinary dosage forms. However, because of some of the unique challenges that are encountered within the framework of veterinary medicine, variations of CDER's approach are presented. The present manuscript discusses HVD and highly variable veterinary drugs (HVVD) from the perspective of possible alternative approaches to support the assessment of product BE in veterinary medicine. Limitations in the use of 3- and 4-way crossover study designs are enumerated. In addition to a need for a statistical analysis of HVVD when using a parallel study design, the use of the secondary criteria (test-to-reference ratio), definition of σ(0) , and average BE with expanding limits are raised. A number of the details need to be finalized, from the selection of a regulatory constant to the determination of 'highly variable' in a veterinary drug product. Academicians, industrial scientists, and regulators should continue this discussion and resolve these details.

  5. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning... and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water...

  6. 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

    ... compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient... monograph title, and the strength will be expressed in terms of the active moiety. The policy allows...

  7. 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

  8. 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

  9. 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.

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  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 357.810 - Active ingredients for deodorant drug products for internal use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active ingredients for deodorant drug products for internal use. 357.810 Section 357.810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant...

  16. 21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active ingredients for deodorant drug products for internal use. 357.810 Section 357.810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant...

  17. 21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active ingredients for deodorant drug products for internal use. 357.810 Section 357.810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant...

  18. 21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active ingredients for deodorant drug products for internal use. 357.810 Section 357.810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant...

  19. 21 CFR 357.810 - Active ingredients for deodorant drug products for internal use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Active ingredients for deodorant drug products for internal use. 357.810 Section 357.810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... HUMAN USE Deodorant Drug Products for Internal Use § 357.810 Active ingredients for deodorant...

  20. 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...

  1. Expression of peroxisome proliferator activator receptor β/δ (PPARβ/δ) in acne vulgaris.

    PubMed

    Elmongy, Naglaa Nabil; Shaker, Olfat

    2012-01-01

    Sebum production is the key factor in the pathophysiology of acne. Studies in sebocyte and human sebaceous gland biology indicate that agonists of peroxisome proliferator-activated receptors (PPARs) alter sebaceous lipid production. Our objective was to detect the expression of PPARβ/δ in acne lesions and find its contribution to disease pathogenesis. Twenty five acne vulgaris patients (14 males, 11 females) were included. In addition, 12 healthy volunteers (6 males, 6 females) served as controls. Punch biopsies (3mm) were taken from lesional skin of all patients, non-lesional skin in 12 patients, and from the healthy controls. The biopsies were estimated quantitatively for the level of PPARβ/δ mRNA using reverse transcriptase-polymerase chain (RT-PCR) technique. PPARβ/δ mRNA levels were significantly higher in patients than controls (p=0.00) and in patients' lesional than non-lesional skin (p=0.00). No significant difference however, was found between inflammatory and non-inflammatory lesions. Age and disease duration had no influence on mean PPAR mRNA levels in lesional skin. PPARβ/δ is over expressed-in inflammatory and non-inflammatory acne vulgaris and may well be considered as a candidate target in future acne therapy. However, elucidation of its functional role is recommended.

  2. The Use of Lipohydroxy Acid in Skin Care and Acne Treatment

    PubMed Central

    2016-01-01

    Lipohydroxy acid is a derivative of salicylic acid with unique properties that explain its clinical effects in the skin. Lipohydroxy acid has skin renewing, exfoliating, and acne treating properties and is a commonly used ingredient in personal skin care products. The slow penetration of lipohydroxy acid results in an individual cell-by-cell exfoliation that is associated with excellent tolerability. Lipohydroxy acid has been shown to induce dermal thickening by stimulating glycosaminoglycans, collagen, and elastin production. Finally, lipohydroxy acid has been demonstrated to possess comedolytic properties. This article reviews the available data on the use of lipohydroxy acid in treating aging skin and acne. PMID:28210389

  3. TLR-2 Recognizes Propionibacterium acnes CAMP Factor 1 from Highly Inflammatory Strains

    PubMed Central

    Ollagnier, Guillaume; Désiré, Nathalie; Sayon, Sophie; Raingeaud, Jöel; Marcelin, Anne-Geneviève; Calvez, Vincent; Khammari, Amir; Batteux, Frédéric; Dréno, Brigitte; Dupin, Nicolas

    2016-01-01

    Background Propionibacterium acnes (P. acnes) is an anaerobic, Gram-positive bacteria encountered in inflammatory acne lesions, particularly in the pilosebaceous follicle. P. acnes triggers a strong immune response involving keratinocytes, sebocytes and monocytes, the target cells during acne development. Lipoteicoic acid and peptidoglycan induce the inflammatory reaction, but no P. acnes surface protein interacting with Toll-like receptors has been identified. P. acnes surface proteins have been extracted by lithium stripping and shown to induce CXCL8 production by keratinocytes. Methodology and principal findings Far-western blotting identified two surface proteins, of 24.5- and 27.5-kDa in size, specifically recognized by TLR2. These proteins were characterized, by LC-MS/MS, as CAMP factor 1 devoid of its signal peptide sequence, as shown by N-terminal sequencing. Purified CAMP factor 1 induces CXCL8 production by activating the CXCL8 gene promoter, triggering the synthesis of CXCL8 mRNA. Antibodies against TLR2 significantly decreased the CXCL8 response. For the 27 P. acnes strains used in this study, CAMP1-TLR2 binding intensity was modulated and appeared to be strong in type IB and II strains, which produced large amounts of CXCL8, whereas most of the type IA1 and IA2 strains presented little or no CAMP1-TLR2 binding and low levels of CXCL8 production. The nucleotide sequence of CAMP factor displays a major polymorphism, defining two distinct genetic groups corresponding to CAMP factor 1 with 14 amino-acid changes from strains phylotyped II with moderate and high levels of CAMP1-TLR2 binding activity, and CAMP factor 1 containing 0, 1 or 2 amino-acid changes from strains phylotyped IA1, IA2, or IB presenting no, weak or moderate CAMP1-TLR2 binding. Conclusions Our findings indicate that CAMP factor 1 may contribute to P. acnes virulence, by amplifying the inflammation reaction through direct interaction with TLR2. PMID:27902761

  4. An update on the role of the sebaceous gland in the pathogenesis of acne

    PubMed Central

    Makrantonaki, Evgenia; Ganceviciene, Ruta

    2011-01-01

    The pathogenesis of acne, a disease of the pilosebaceous follicle and one of the most common chronic skin disorders, is attributed to multiple factors such as increased sebum production, alteration of the quality of sebum lipids, inflammatory processes, dysregulation of the hormone microenvironment, interaction with neuropeptides, follicular hyperkeratinisation and the proliferation of Propionibacterium acnes within the follicle. In particular, the sebaceous gland plays an exquisite role in the initiation of the disease as it possesses all the enzyme machinery for the production of hormones and cytokines. In addition, in response to the altered tissue environment in the pilosebaceous follicle as well as in answer to emotional fret, stress response system mechanisms with induction of central and local expression of neuropeptides, are also initiated. This review summarises the latest advances in understanding the role of sebaceous gland cells in the pathomechanism of acne. PMID:21519409

  5. 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:...

  6. 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:...

  7. 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:...

  8. 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:...

  9. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... incontinence.” (c) Warnings. The labeling of the product contains the following warnings under the heading... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of deodorant drug products for internal... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR...

  10. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... incontinence.” (c) Warnings. The labeling of the product contains the following warnings under the heading... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of deodorant drug products for internal... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR...

  11. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... incontinence.” (c) Warnings. The labeling of the product contains the following warnings under the heading... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of deodorant drug products for internal... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR...

  12. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... incontinence.” (c) Warnings. The labeling of the product contains the following warnings under the heading... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of deodorant drug products for internal... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR...

  13. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... incontinence.” (c) Warnings. The labeling of the product contains the following warnings under the heading... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of deodorant drug products for internal... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR...

  14. 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

  15. 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

  16. 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

  17. Comparing Drug-Disease Associations in Clinical Practice Guideline Recommendations and Drug Product Label Indications.

    PubMed

    Leung, Tiffany I; Dumontier, Michel

    2015-01-01

    Clinical practice guidelines (CPGs) and structured product labels (SPLs) are both intended to promote evidence-based medical practices and guide clinicians' prescribing decisions. However, it is unclear how well CPG recommendations about pharmacologic therapies for certain diseases match SPL indications for recommended drugs. In this study, we use publicly available data and text mining methods to examine drug-disease associations in CPG recommendations and SPL treatment indications for 15 common chronic conditions. Preliminary results suggest that there is a mismatch between guideline-recommended pharmacologic therapies and SPL indications. Conflicting or inconsistent recommendations and indications may complicate clinical decision making and implementation or measurement of best practices.

  18. [Studies on market of drug delivery system product and drug delivery system of compound Chinese medicine].

    PubMed

    Feng, Yi; Xu, De-Sheng; Hong, Yan-Long; Zhang, Ning; Ma, Yue-Ming

    2006-10-01

    Based on the progress in the world market of drug delivery system (DDS) product and the research profile of DDS of compound Chinese Medicine, The article puts forward a new method of studies on DDS of compound Chinese Medicine. It is expected that the theory of compatibility of compound Chinese Medicine can be shown and its role can be exerted to the largest extent with the application of pharmaceutics technology to change the mode of drug delivery of activated components of compound Chinese Medicine.

  19. Liposomal Drug Product Development and Quality: Current US Experience and Perspective.

    PubMed

    Kapoor, Mamta; Lee, Sau L; Tyner, Katherine M

    2017-02-03

    Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency has received over 400 liposomal drug product submissions (excluding combination therapies), and there are currently eight approved liposomal drug products on the US market. In order to identify the pain points in development and manufacturing of liposomal drug products, a retrospective analysis was performed from a quality perspective on submissions for new and generic liposomal drug products. General analysis on liposomal drug product submissions was also performed. Results indicated that 96% of the submissions were Investigational New Drug (IND) applications, 3% were New Drug Applications (NDAs), and the remaining 1% was Abbreviated New Drug Applications (ANDAs). Doxorubicin hydrochloride was the most commonly used drug substance incorporated into the liposomes (31%). The majority of the liposomal products were administered via intravenous route (84%) with cancer (various types) being the most common indication (63%). From a quality perspective, major challenges during the development of liposomal drug products included identification and (appropriate) characterization of critical quality attributes of liposomal drug products and suitable control strategies during product development. By focusing on these areas, a faster and more efficient development of liposomal drug products may be achieved. Additionally, in this way, the drug review process for such products can be streamlined.

  20. Drug development from natural products: exploiting synergistic effects.

    PubMed

    Ulrich-Merzenich, Gudrun; Panek, D; Zeitler, H; Vetter, H; Wagner, H

    2010-03-01

    Drug development in phytomedicine has been focused in the past on the discovery and analysis of new structures from natural products. The search aimed at the determination of the single "active principle" in plants, based on the assumption that a plant has one or a few ingredients which determine its therapeutic effects. But traditional systems of medicines like Ayurveda, traditional Chinese medicine or the European phytotherapy generally assume that a synergy of all ingredients of the plants will bring about the maximum of therapeutic efficacy. This approach has for long been impossible to investigate since adequate methods to standardize complex plant mixtures as well as to rationalize complex mode of actions were lacking. The introduction of high throughput technologies provides the opportunity to determine profiles of plants and to systematically explore the mode of action of combinatory drug regimes. The present review highlights the concept of synergy and gives examples of synergistic effects of plant constituents. It elaborates on how the high throughput technologies can be used in drug development from natural products with the aim of creating evidence-based plant medications in prevention and treatment of different diseases in the form of new single treatments or new combinatory drug regimes while exploiting synergy-effects.

  1. 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.

  2. The role of Chlamydia pneumoniae in the etiology of acne rosacea: response to the use of oral azithromycin.

    PubMed

    Fernandez-Obregon, Adolfo; Patton, Dorothy L

    2007-02-01

    Acne rosacea is a chronic skin disorder that requires long-term therapy. Oral azithromycin has been used successfully to treat acne vulgaris. an observation that suggested an infectious agent may play an active role in the etiology of this disorder. Ten adults (not previously reported) with acne rosacea were selected to be treated with oral azithromycin. Nine of the 10 subjects received 250 mg 3 times weekly for periods ranging from 5 to 19 weeks, at which time follow-up examinations were performed on 8 of the 9 treated subjects: 1 subject was lost to follow-up. Prior to therapy. C pneumoniae antigen was detected in malar biopsy specimens in 4 of 10 subjects by immunoperoxidase technique (using monoclonal antibody to C pneumoniae). Serum antibodies against C pneumoniae were detected in 8 of 10 intent-to-treat subjects. Using polymerase chain reaction, C pneumoniae was not detected in peripheral blood mononuclear cells. The inflammatory response in tissues was characterized by a widespread infiltration of polymorphonuclear neutrophil cells, lymphocytes, and plasma cells, which support the clinical diagnosis of acne rosacea. Nine of 10 subjects treated with azithromycin showed moderate to marked improvement of their acne rosacea. No adverse reactions to azithromycin occurred. and the drug appeared to be safe and effective. These preliminary data suggest the need for further investigation with clinical trials to study long-term tolerability and efficacy and also strongly implicate C pneumoniae in the pathogenesis of acne rosacea.

  3. Pro-inflammatory cytokines in patients with various kinds of acne treated with isotretinoin

    PubMed Central

    Brzezińska-Wcisło, Ligia

    2014-01-01

    Introduction Acne vulgaris is the most frequently diagnosed dermatosis in patients aged between 11 and 30. It is believed that it affects about 80% of persons in this age group or even, taking into account lesions of low intensity, 100% of young people. The role of cytokines in the pathogenesis of acne is not fully known. The TLR2 receptors play a role in the aetiology of acne. Stimulation of TLR2 by Propionibacterium acnes makes the IL-8 and IL-12 concentrations increase. Aim The aim of this work was to determine IL-1β, IL-1α, IL-8 and TNF-α levels in patients’ sera used to test response to TLR2 stimulation. A decrease in the levels of the above mentioned cytokines together with a decrease in sebum production were defined as an indication of efficient treatment with isotretinoin. Material and methods The tests were performed in 155 patients treated for different clinical forms of acne with an oral isotretinoin preparation in the Dermatology Clinic of the Silesian Medical University in Katowice in 2009–2011 – I group and the patients treated with oral isotretinoin 2 and 5 years ago – II group. The control group consisted of 40 healthy individuals. Conclusions Measurements of IL-1α, IL-1β and TNF-α sera concentrations could be assessed in parallel to the improvement of the clinical condition and can constitute a good indication of the efficiency of the isotretinoin treatment. PMID:24683393

  4. New developments in acne treatment: role of combination adapalene–benzoylperoxide

    PubMed Central

    Kim, Su Youn; Ochsendorf, Falk R

    2016-01-01

    The fixed-dose combination adapalene 0.1%/benzoylperoxide 2.5% (A/BPO) was introduced as an acne vulgaris therapeutic in 2007. It combines anti-inflammatory, keratolytic, comedolytic, and antibacterial properties. Thus, it addresses several pathophysiological factors involved in the pathophysiology of acne. This review highlights the rationale for the use of this fixed-dose combination product, its therapeutic efficacy including effects on adherence and quality of life, its use for different forms of acne, and the side-effect profile. In summary, the fixed-dose combination of A/BPO gel can be regarded as a highly effective and safe formulation. It is not associated with antibiotic resistance. It reduces factors that cause nonadherence and has positive effects on the quality of life of affected patients. The tolerance is good. The initial mild irritation potential can be addressed by adequate counseling. A/BPO can be used for all forms of inflammatory acne, including severe forms, as part of a combination with systemic antibiotics. Finally, it can also be used for the long-term treatment of chronic acne. Thus, it is a very valuable therapeutic option in daily practice, which is reflected by its strong recommendation in the “European S3-guidelines”. PMID:27757036

  5. Correlation between the severity and type of acne lesions with serum zinc levels in patients with acne vulgaris.

    PubMed

    Rostami Mogaddam, Majid; Safavi Ardabili, Nastaran; Maleki, Nasrollah; 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.

  6. Sebum analysis of individuals with and without acne

    PubMed Central

    Johnsen, Stefanie; Liu, Jue-Chen; Eisinger, Magdalena

    2009-01-01

    A pilot study was conducted to compare lipid components of sebum from unaffected and acne-affected individuals. Nine males, 15–20 years old, with no acne, or with moderate to severe acne, were recruited. Facial images were taken with regular, polarized and fluorescent lights for each subject. Skin surface lipids were analyzed following collection of sebum using sebutapes. As expected, the subjects with acne had more (59%) sebum than the control subjects. Free fatty acids were the only lipid group that was reduced in the sebum of acne subjects. The specific lipid that differed the most between the two groups was squalene, which was upregulated in acne subjects by 2.2-fold on a quantitative basis. Squalene also represented a significantly greater proportion of the total sebaceous lipids in acne patients compared to controls (20% vs. 15%). The increase in the amount of squalene could represent a lipid marker for acne prone skin. PMID:20436883

  7. Public databases of plant natural products for computational drug discovery.

    PubMed

    Tung, Chun-Wei

    2014-01-01

    Plant natural products have been intensively investigated during the past decades with a considerable amount of generated data. Databases are subsequently developed to facilitate the management and analysis of accumulated information including plant species, chemical compounds, structures and bioactivities. With the support of databases, the screening of novel bioactivities for plant natural products can benefit from advanced computational methods to accelerate the progress of drug discovery. This overview describes the contents of publicly available databases useful for computational research of plant natural products. Based on the databases, quantitative structure-activity relationship models and protein-ligand docking methods can be developed and applied to analyze and screen bioactive compounds. More public and structured databases with unique contents, search functions and links to major databases are needed for efficiently exploring the chemical space of plant natural products.

  8. Acne located on the trunk, whey protein supplementation: Is there any association?

    PubMed Central

    Cengiz, Fatma Pelin; Cevirgen Cemil, Bengu; Emiroglu, Nazan; Gulsel Bahali, Anil; Onsun, Nahide

    2017-01-01

    Whey protein is a source of protein that was isolated from milk. Whey proteins are composed of higher levels of essential amino acids. The role of diet in acne etiology has been investigated for several years. It was established that milk and milk products can trigger acneiform lesions, and recent evidence supports the role of whey protein supplements in acne. Herein, we report 6 healthy male adolescent patients developing acne located only to the trunk after the consumption of whey protein supplements for faster bodybuilding. This is the first observation which specified the location of acneiform lesions among bodybuilders. In our opinion, a trendy and common health problem is beginning among adolescents in the gyms. PMID:28326292

  9. Emerging Issues in Adult Female Acne

    PubMed Central

    Baldwin, Hillary E.; Cook-Bolden, Fran E.; Eichenfield, Lawrence F.; Friedlander, Sheila F.; Rodriguez, David A.

    2017-01-01

    Acne vulgaris (acne) is a common affliction in adolescence and is a growing problem in adult women. Despite an increasing awareness of acne in the adult female population, there is a lack of good prospective studies assessing the severity, distribution, and differential response to treatment in this group. The long-held dogma that acne in adult women develops on the lower one-third of the face has been recently challenged, and here the authors critically review data from available literature. Moreover, while adult female acne has traditionally been defined as disease in women over age 25, it is the authors’ experience that this group is subdivided into women ages 25 to 44 years, separate from perimenopausal patients, ages 45 years and up. While there is no data specifically comparing these two groups, the authors will review the existing data and provide practical recommendations based on our experience in treating these groups of patients. Finally, while there is a lack of data on this subject, it is the group’s opinion that adherence to medication regimens is likely higher in women than men, which influences therapeutic outcomes. PMID:28210380

  10. Treatment of acne vulgaris in pregnant patients.

    PubMed

    Pugashetti, Rupa; Shinkai, Kanade

    2013-01-01

    The management of acne vulgaris in the setting of pregnancy raises important clinical considerations regarding the efficacy and safety of acne treatments in this special patient population. Particular challenges include the absence of safety data, discrepancy in safety data between different safety rating systems, and lack of evidence-based recommendations for the treatment of acne during pregnancy. Nonetheless, many therapeutic options exist, and the treatment of acne in pregnant women can be safely and often effectively accomplished. For mild or moderate disease, patients can be treated with topical antimicrobial agents, anti-inflammatory agents, as well as glycolic and salicylic acid. Several topical agents, notably benzoyl peroxide, previously viewed as potentially dangerous are cited by many sources as being considered safe. When necessary, systemic therapies that can be safely added include penicillins, amoxicillin, cephalosporins, erythromycin, clindamycin, and tetracyclines or sulfonamides, depending on the stage of fetal development. Adjunct therapy may include phototherapy or laser treatments. Physicians should work with this often highly motivated, safety-conscious patient population to tailor an individualized treatment regimen. This treatment regimen will likely shift throughout the different stages of fetal development, as distinct safety considerations are raised prior to conception as well as during each of the trimesters of pregnancy. Important considerations regarding acne management in breast-feeding mothers is also discussed.

  11. 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.

  12. Natural products as leads in schistosome drug discovery.

    PubMed

    Neves, Bruno J; Andrade, Carolina H; Cravo, Pedro V L

    2015-01-23

    Schistosomiasis is a neglected parasitic tropical disease that claims around 200,000 human lives every year. Praziquantel (PZQ), the only drug recommended by the World Health Organization for the treatment and control of human schistosomiasis, is now facing the threat of drug resistance, indicating the urgent need for new effective compounds to treat this disease. Therefore, globally, there is renewed interest in natural products (NPs) as a starting point for drug discovery and development for schistosomiasis. Recent advances in genomics, proteomics, bioinformatics, and cheminformatics have brought about unprecedented opportunities for the rapid and more cost-effective discovery of new bioactive compounds against neglected tropical diseases. This review highlights the main contributions that NP drug discovery and development have made in the treatment of schistosomiasis and it discusses how integration with virtual screening (VS) strategies may contribute to accelerating the development of new schistosomidal leads, especially through the identification of unexplored, biologically active chemical scaffolds and structural optimization of NPs with previously established activity.

  13. 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

  14. 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

    ... Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily... Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors...

  15. Identification of AcnR, a TetR-type repressor of the aconitase gene acn in Corynebacterium glutamicum.

    PubMed

    Krug, Andreas; Wendisch, Volker F; Bott, Michael

    2005-01-07

    In Corynebacterium glutamicum, the activity of aconitase is 2.5-4-fold higher on propionate, citrate, or acetate than on glucose. Here we show that this variation is caused by transcriptional regulation. In search for putative regulators, a gene (acnR) encoding a TetR-type transcriptional regulator was found to be encoded immediately downstream of the aconitase gene (acn) in C. glutamicum. Deletion of the acnR gene led to a 5-fold increased acn-mRNA level and a 5-fold increased aconitase activity, suggesting that AcnR functions as repressor of acn expression. DNA microarray analyses indicated that acn is the primary target gene of AcnR in the C. glutamicum genome. Purified AcnR was shown to be a homodimer, which binds to the acn promoter in the region from -11 to -28 relative to the transcription start. It thus presumably acts by interfering with the binding of RNA polymerase. The acn-acnR organization is conserved in all corynebacteria and mycobacteria with known genome sequence and a putative AcnR consensus binding motif (CAGNACnnncGTACTG) was identified in the corresponding acn upstream regions. Mutations within this motif inhibited AcnR binding. Because the activities of citrate synthase and isocitrate dehydrogenase were previously reported not to be increased during growth on acetate, our data indicate that aconitase is a major control point of tricarboxylic acid cycle activity in C. glutamicum, and they identify AcnR as the first transcriptional regulator of a tricarboxylic acid cycle gene in the Corynebacterianeae.

  16. 77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Single-Ingredient, Immediate-Release Drug Products... AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug... such products in interstate commerce. The document was published with an incorrect Web link....

  17. 21 CFR 211.86 - Use of approved 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 Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  18. 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...

  19. 21 CFR 211.87 - Retesting of approved 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 Retesting of approved components, drug product containers, and closures. 211.87 Section 211.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  20. 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...

  1. 21 CFR 211.86 - Use of approved 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 Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  3. 21 CFR 211.82 - Receipt and storage of untested 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 Receipt and storage of untested components, drug product containers, and closures. 211.82 Section 211.82 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE...

  4. 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...

  5. 21 CFR 211.82 - Receipt and storage of untested 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 Receipt and storage of untested components, drug product containers, and closures. 211.82 Section 211.82 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE...

  6. 21 CFR 211.86 - Use of approved 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 Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  7. 21 CFR 211.86 - Use of approved 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 Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  8. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  9. 21 CFR 211.87 - Retesting of approved 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 Retesting of approved components, drug product containers, and closures. 211.87 Section 211.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  10. 21 CFR 211.87 - Retesting of approved 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 Retesting of approved components, drug product containers, and closures. 211.87 Section 211.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  11. 21 CFR 211.87 - Retesting of approved 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 Retesting of approved components, drug product containers, and closures. 211.87 Section 211.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  12. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  13. 21 CFR 211.82 - Receipt and storage of untested 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 Receipt and storage of untested components, drug product containers, and closures. 211.82 Section 211.82 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE...

  14. 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...

  15. 21 CFR 211.82 - Receipt and storage of untested 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 Receipt and storage of untested components, drug product containers, and closures. 211.82 Section 211.82 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE...

  16. 21 CFR 211.110 - Sampling and testing of in-process materials and drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sampling and testing of in-process materials and drug products. 211.110 Section 211.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  17. 21 CFR 212.110 - How must I maintain records of my production of PET drugs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false How must I maintain records of my production of PET drugs? 212.110 Section 212.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  18. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  19. 21 CFR 1304.26 - Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid. 1304.26 Section 1304.26 Food and Drugs DRUG... accordance with an application under section 505 of the Federal Food, Drug, and Cosmetic Act must...

  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. 310.518 Section 310.518 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... requirements: (a) Labeling. (1) The label of any drug in solid oral dosage form (e.g., tablets or...

  1. 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.

  2. 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.

  3. Ethinylestradiol + cyproterone: back in France for acne and hirsutism, despite frequent off-label prescription.

    PubMed

    2014-07-01

    Following a European review, products containing the ethinylestradiol + cyproterone combination are back on the French market for women with acne (as second-line treatment) or hirsutism. Yet experience has shown that frequent off-label prescription of this combination for contraceptive purposes exposes many women to an unjustified risk of thromboembolism.

  4. 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

  5. THERAPEUTIC AGENTS IN ACNE VULGARIS. I. TETRACYCLINE.

    PubMed

    STEWART, W D; MADDIN, S; NELSON, A J; DANTO, J L

    1963-11-23

    A total of 120 consecutive patients with pustular and cystic acne vulgaris were selected for study. Patients were assigned a placebo and a tetracycline medication in a random method. Of the 53 patients who were given tetracycline, 45 showed some response, which was fair in 19 and excellent in 26. Of the 55 patients who received placebo, 24 showed no response while 31 showed some improvement. No side effects were reported. The difference in response between the two groups is statistically significant. It is concluded that administration of 250 mg. tetracycline four times daily, even for periods as short as two weeks, enhances the likelihood of improvement of cystic or pustular acne vulgaris.

  6. Ultraviolet phototherapy and photochemotherapy of acne vulgaris.

    PubMed

    Mills, O H; Kligman, A M

    1978-02-01

    The therapeutic value of various ultraviolet treatments was assessed in patients with moderately severe papulopustular acne. The results did not verify the common belief that ultraviolet radiation is highly beneficial. In no instance was the comedo count appreciably reduced. Modest improvement was observed with sunburn rays (UV-B) and slightly more with the combination of long ultraviolet radiation (UV-A) and UV-B. UV-A alone had the least effect. Photosensitization with coal tar and UV-A greatly aggravated acne and was notably comedogenic. Photosensitization with methoxsalen (8-methoxypsoralen) applied topically was neither harmful nor helpful.

  7. Acne Fulminans: Case Series and Review of the Literature.

    PubMed

    Alakeel, Abdullah; Ferneiny, Marie; Auffret, Nicole; Bodemer, Christine

    2016-11-01

    Acne fulminans (AF) is a rare manifestation and the most severe form of the entire clinical spectrum of acne. The disease is destructive and is characterized by the sudden onset of painful and ulcerative pustules and systemic symptoms including high fever, hepatomegaly, polyarthralgia, leukocytosis, plaquetose, and increased inflammatory markers and transaminases. Osteolytic lesions in multiple skeletal sites could also be associated. The use of isotretinoin is considered a related trigger, as well as the use and cessation of testosterone, although a bacterial infection, a drug-induced disease, or an intake of anabolic androgenic steroids has been suggested. The treatment of AF is challenging and controversial. The recommended treatment is aggressive and consists of a combination of oral steroids and low doses of isotretinoin, with no consensus at this time. The patient may require several weeks of hospitalization to control the eruption. The cutaneous lesions usually leave scars and milia. We report on two boys and two girls presenting with AF, triggered by isotretinoin in three patients and by an antibiotic in one patient. All the patients treated with corticosteroids and isotretinoin with success.

  8. 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.

  9. 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.

  10. Analysis of clinical efficacy, side effects, and laboratory changes among patients with acne vulgaris receiving single versus twice daily dose of oral isotretinoin.

    PubMed

    Ahmad, Hesham M

    2015-01-01

    Acne vulgaris is a debilitating disorder and requires proper treatment. This work evaluates the clinical efficacy, side effects, and laboratory changes of serum lipids and liver function during oral isotretinoin therapy for acne vulgaris, comparing single versus twice daily dose. Fifty-eight patients with acne vulgaris were included and randomized into group I (26 patients), who received once daily dose, and group II (32 patients), who received twice daily dose of oral isotretinoin. Global acne scoring system was used to evaluate acne severity and post-treatment improvement. Both regimens resulted in highly significant clinical improvement of acne with no significant difference. However, side effects were significantly more common among patients of group I. Both regimens caused mild rise of serum cholesterol, alanine transaminase (ALT), and aspartate aminotransferase (AST) with more prominent rise of triglycerides especially with twice daily dose. Oral isotretinoin is a very effective treatment for acne vulgaris with no statistically significant difference in clinical efficacy between once and twice daily doses. However, dividing dose to twice per day might cause fewer incidence of side effects without reducing clinical efficacy. The drug causes mild clinically insignificant rise of serum cholesterol, triglycerides, AST, and ALT.

  11. 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.

  12. Systemic corticosteroid and isotretinoin treatment in cystic acne.

    PubMed

    Karvonen, S L; Vaalasti, A; Kautiainen, H; Reunala, T

    1993-12-01

    Prednisolone combined with erythromycin was given to 6 patients with cystic acne. The treatment responses were compared to those in 6 patients with cystic acne receiving isotretinoin and erythromycin and also to those in 3 patients with acne fulminans treated with prednisolone and erythromycin. During the first 4 weeks cystic acne showed a clear improvement in 5 out of 6 patients in both treatment groups. A similar improvement occurred in all 3 patients with acne fulminans. When corticosteroid was stopped, 2 out of 5 patients with cystic acne had a relapse and needed isotretinoin for complete control. In the isotretinoin-treated group, one patient with cystic acne needed prednisolone because the acne worsened to an ulcerative form. Slightly elevated liver enzymes, possibly due to erythromycin treatment, were observed in 2 patients with cystic acne and in one patient with acne fulminans. The present results show that prednisolone combined with erythromycin is an effective treatment during the early stages of cystic and febrile acne, but isotretinoin is needed for long-term control.

  13. 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.

  14. Impurities in Drug Products and Active Pharmaceutical Ingredients.

    PubMed

    Kątny, M; Frankowski, M

    2016-09-29

    Analytical methods should be selective and fast. In modern times, scientists strive to meet the criteria of green chemistry, so they choose analytical procedures that are as short as possible and use the least toxic solvents. It is quite obvious that the products intended for human consumption should be characterized as completely as possible. The safety of a drug is dependent mainly on the impurities that it contains. High pressure liquid chromatography and ultra-high pressure liquid chromatography have been proposed as the main techniques for forced degradation and impurity profiling. The aim of this article was to characterize the relevant classification of drug impurities and to review the methods of impurities determination for atorvastatin (ATV) and duloxetine (DLX) (both in active pharmaceutical ingredients and in different dosage forms). These drugs have an impact on two systems of the human body: cardiac and nervous. Simple characteristics of ATV and DLX, their properties and specificity of action on the human body, are also included in this review. The analyzed pharmaceuticals-ATV (brand name Lipiron) and DLX (brand name Cymbalta)-were selected for this study based on annual rankings prepared by Information Medical Statistics.

  15. Photodynamic therapy in the management of acne: an update.

    PubMed

    Elsaie, Mohamed L; Choudhary, Sonal

    2010-09-01

    Acne, one of the most common dermatological diseases, is characterized by inflammatory and noninflammatory lesions that may progress to scars. Starting from pubertal age groups, it can affect adults in the age group 35-40 or more. The conventional therapies for treatment of acne are facing roadblocks because of the antibiotic resistance developing against Propionibacterium acnes. This has led to trying new therapies, of which photodynamic therapy (PDT) seems to be the one under intensive study. Promising results have been observed with PDT use in acne treatment, but it still has some more way to go to acquire the FDA approval for use in acne treatment. This is a review of the literature of use of PDT in treatment of acne, providing a starting point for dermatologists seeking to treat their patients with acne safely and effectively with this new method.

  16. 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

  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.

  18. Antimicrobial drug resistance of Staphylococcus aureus in dairy products

    PubMed Central

    Sasidharan, S; Prema, B; Yoga, Latha L

    2011-01-01

    Objective To evaluate the prevalence of multidrug resistant Staphylococcus aureus (S. aureus) in dairy products. Methods Isolation and identification of S. aureus were performed in 3 dairy-based food products. The isolates were tested for their susceptibility to 5 different common antimicrobial drugs. Results Of 50 samples examined, 5 (10%) were contaminated with S. aureus. Subsequently, the 5 isolates were subjected to antimicrobial resistance pattern using five antibiotic discs (methicillin, vancomycin, kanamycin, chloramphenicol and tetracycline). Sample 29 showed resistance to methicillin and vancomycin. Sample 18 showed intermediate response to tetracycline. The other samples were susceptible to all the antibiotics tested. Conclusions The results provide preliminary data on sources of food contamination which may act as vehicles for the transmission of antimicrobial-resistant Staphylococcus. Therefore, it enables us to develop preventive strategies to avoid the emergence of new strains of resistant S. aureus. PMID:23569742

  19. Potential strategies for increasing drug-discovery productivity.

    PubMed

    Cumming, John G; Finlay, M Raymond V; Giordanetto, Fabrizio; Hemmerling, Martin; Lister, Troy; Sanganee, Hitesh; Waring, Michael J

    2014-04-01

    The productivity challenge facing the pharmaceutical industry is well documented. Strategies to improve productivity have mainly focused on enhancing efficiency, such as the application of Lean Six Sigma process improvement methods and the introduction of modeling and simulation in place of 'wet' experiments. While these strategies have their benefits, the real challenge is to improve effectiveness by reducing clinical failure rates. We advocate redesigning the screening cascade to identify and optimize novel compounds with improved efficacy against disease, not just with improved potency against the target. There should be greater use of disease-relevant phenotypic screens in conjunction with target-based assays to drive medicinal chemistry optimization. An opportunistic approach to polypharmacology is recommended. There should also be more emphasis on optimization of the molecular mechanism of action incorporating understanding of binding kinetics, consideration of covalent drug strategies and targeting allosteric modulators.

  20. 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

  1. Inhibition of Propionibacterium acnes lipase by extracts of Indian medicinal plants.

    PubMed

    Patil, V; Bandivadekar, A; Debjani, D

    2012-06-01

    Lipases play an important role in pathogenesis of acne by hydrolysing sebum triglycerides and releasing irritating free fatty acids in the pilosebaceous follicles. Lipase is a strong chemotactic and proinflammatory antigen. Therefore, lipase has generated a high interest as a pharmacological target for antiacne drugs. The aim of this study was to identify inhibitory effects of plant extracts on the lipase activity of Propionibacterium acnes. Colorimetric microassay was used to determine lipase activity. Extracts from Terminalia chebula and Embelia ribes showed lower IC(50) value (1 μg mL(-1) ) for lipase inhibition as compared to Vitex negundo and Picrorhiza kurroa (19 and 47 μg mL(-1) , respectively). The active component responsible for lipase inhibition was isolated. This study reports for the first time the novel antilipase activity of chebulagic acid (IC(50) : 60 μmol L(-1) ) with minimum inhibitory concentration value of 12.5 μg mL(-1) against P. acnes. The inhibitory potential of plant extracts was further confirmed by plate assay. The organism was grown in the presence of subinhibitory concentrations of extracts from P. kurroa, V. negundo, T. chebula, E. ribes and antibiotics such as clindamycin and tetracycline. Extract from T. chebula showed significant inhibition of lipase activity and number of P. acnes.

  2. 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...

  3. Dissolution Failure of Solid Oral Drug Products in Field Alert Reports.

    PubMed

    Sun, Dajun; Hu, Meng; Browning, Mark; Friedman, Rick L; Jiang, Wenlei; Zhao, Liang; Wen, Hong

    2017-01-17

    From 2005 to 2014, 370 data entries of dissolution failures of solid oral drug products were assessed with respect to the solubility of drug substances, dosage forms [immediate release (IR) vs. modified release (MR)], and manufacturers (brand name vs. generic). The study results show that the solubility of drug substances does not play a significant role in dissolution failures; however, MR drug products fail dissolution tests more frequently than IR drug products. When multiple variables were analyzed simultaneously, poorly water-soluble IR drug products failed the most dissolution tests, followed by poorly soluble MR drug products and very soluble MR drug products. Interestingly, the generic drug products fail dissolution tests at an earlier time point during a stability study than the brand name drug products. Whether the dissolution failure of these solid oral drug products has any in vivo implication will require further pharmacokinetic, pharmacodynamic, clinical, and drug safety evaluation. Food and Drug Administration is currently conducting risk-based assessment using in-house dissolution testing, physiologically based pharmacokinetic modeling and simulation, and post-market surveillance tools. At the meantime, this interim report will outline a general scheme of monitoring dissolution failures of solid oral dosage forms as a pharmaceutical quality indicator.

  4. Cheminformatic comparison of approved drugs from natural product versus synthetic origins.

    PubMed

    Stratton, Christopher F; Newman, David J; Tan, Derek S

    2015-11-01

    Despite the recent decline of natural product discovery programs in the pharmaceutical industry, approximately half of all new drug approvals still trace their structural origins to a natural product. Herein, we use principal component analysis to compare the structural and physicochemical features of drugs from natural product-based versus completely synthetic origins that were approved between 1981 and 2010. Drugs based on natural product structures display greater chemical diversity and occupy larger regions of chemical space than drugs from completely synthetic origins. Notably, synthetic drugs based on natural product pharmacophores also exhibit lower hydrophobicity and greater stereochemical content than drugs from completely synthetic origins. These results illustrate that structural features found in natural products can be successfully incorporated into synthetic drugs, thereby increasing the chemical diversity available for small-molecule drug discovery.

  5. Natural product-derived drugs for the treatment of inflammatory bowel diseases.

    PubMed

    Joo, Young-Eun

    2014-04-01

    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.

  6. 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

  7. The use of isotretinoin in acne

    PubMed Central

    2009-01-01

    Systemic isotretinoin remains the most efficacious treatment for severe acne as well as many cases of more moderate disease that are unresponsive to other treatment modalities. The current chapter outlines the mechanisms behind the excellent efficacy, describes how to optimize treatment, reviews the recommended guidelines for monitoring and summarizes adverse effects. PMID:20436884

  8. Interventions to increase adherence to acne treatment

    PubMed Central

    Moradi Tuchayi, Sara; Alexander, Tiffany M; Nadkarni, Anish; Feldman, Steven R

    2016-01-01

    Background Adherence to acne medication is poor and is a major reason why treatment plans are ineffective. Recognizing solutions to nonadherence is critical. Objective The purpose of this study is to describe the hurdles associated with acne nonadherence and to provide mechanisms on how to ameliorate them. Methods PubMed database was searched. Of the 419 search results, 29 articles were reviewed to identify hurdles to adherence and corresponding solutions. Results Hurdles to primary nonadherence where the medication is not even started, include lack of knowledge, confusion about usage, weak physician–patient relationship, fear of adverse reactions, and cost. Secondary nonadherence hurdles where the medication is started but is not taken as directed include lack of results, complex regimens, side effects, busy lifestyle, forgetfulness, inconvenience, and psychiatric comorbidity. Solutions to these hurdles include treatment simplification, technology, and dynamic education. Limitations Adherence is affected by numerous factors, but available literature analyzing acne adherence and interventions to improve adherence to treatment is limited. Conclusion There are several hurdles in adhering to acne treatment. Recognition of these hurdles and finding appropriate solutions may be as important to treatment outcomes as choosing the right medication to prescribe. PMID:27784999

  9. 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.

  10. Determining the date of manufacture of drug products from lot numbers.

    PubMed

    Feldman, M J; Souney, P F; Kaul, A F

    1979-11-01

    Information necessary to determine the date of manufacture of many drug products from assigned lot numbers is presented. Eighty-four U.S. drug manufacturers were surveyed by mail. Response was received from 71 (85%) of the companies contacted, but only 34 provided the information necessary to determine the date of manufacture of their drug products from assigned lot numbers. Pharmacists can use this information to remove potentially deteriorated drug products from inventory.

  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. The assessment of impurities for genotoxic potential and subsequent control in drug substance and drug product.

    PubMed

    Dow, Linda K; Hansen, Marvin M; Pack, Brian W; Page, Todd J; Baertschi, Steven W

    2013-05-01

    The strategies implemented at Eli Lilly and Company to address European Medicines Agency and US Food and Drug Administration requirements governing the control of genotoxic impurities (GTIs) are presented. These strategies were developed to provide understanding with regard to the risk and potential liabilities that could be associated with developmental and marketed compounds. The strategies systematize the assessment of impurities for genotoxic potential, addressing both actual and potential impurities. Timing of activities is designed to minimize impact to development timelines while building a data package sufficient to either discharge the risk of potential GTI formation or support the implementation of a specification necessary for long-term control. This article presents the background associated with GTI control, the types of impurities that should be assessed, and the actions to be taken when an impurity is found to be genotoxic. A systematic approach to define potential degradation products derived from stress-testing studies is outlined with a proposal to perform a genotoxic risk assessment on these impurities. Finally, an Arrhenius-based strategy is proposed for a rapid assessment of the likelihood of potential degradation impurities to form in the commercial drug product formulation. Importantly, this article makes a proposal for discharging the risk of a potential GTI with supporting data.

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  19. Dissatisfaction and acne vulgaris in male adolescents and associated factors*

    PubMed Central

    Isaacsson, Viviane Christina Siena; de Almeida, Hiram Larangeira; Duquia, Rodrigo Pereira; Breunig, Juliano de Avelar; de Souza, Paulo Ricardo Martins

    2014-01-01

    BACKGROUND Acne vulgaris has high prevalence, disturbing quality of life during adolescence. OBJECTIVES To measure dissastifaction and acne in 18-year-old male individuals and its associated factors. METHODS A questionnaire was applied by trained interviewers to all boys during selection for the military service. Dissatisfaction and acne was evaluated using a self-administered face scale. Facial, prestrernal and dorsal acne were evaluated separately. RESULTS A total of 2,200 adolescents, aged 18 years, were interviewed. Among these, 1,678 had acne on the face and 974 (54.05%) showed some degree of dissatisfaction. Regarding the impact of acne located on the chest, 326 out of 686 adolescents (47.52%) reported dissatisfaction. For acne located on the back, 568 out of 1,103 affected individuals (51.50%) showed dissatisfaction. Facial / dorsal acne and dissatisfaction were statistically associated with lower income, lower education levels and with non-whites. Presternal acne and dissatisfaction were statistically asssociated with lower income and lower education levels. CONCLUSION This population-based study found a high prevalence of acne on the face, back and chest, with high rates of dissatisfaction. PMID:25054743

  20. 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...

  1. 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...

  2. 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...

  3. 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.

  4. Interchangeability Evaluation of Multisource Ibuprofen Drug Products Using Biowaiver Procedure

    PubMed Central

    Shohin, I. E.; Kulinich, J. I.; Vasilenko, G. F.; Ramenskaya, G. V.

    2011-01-01

    The WHO biowaiver procedure for BCS Class II weak acids was evaluated by running two multisource IR ibuprofen drug products (Ibuprofen, 200 mg tablets, Tatchempharmpreparaty, Russia and Ibuprofen, 200 mg tablets, Biosintez, Russia) with current Marketing Authorizations (i.e. in vivo bioequivalent) through that procedure. Risks associated with excipients interaction and therapeutic index were considered to be not critical. In vitro dissolution kinetic studies were carried out according WHO Guidance (WHO Technical Report Series, No. 937, Annexes 7 and 8) using USP Apparatus II (paddle method) at 75 rpm. Dissolution profiles of test and reference ibuprofen tablets were considered equivalent in pH 4.5 using factors f1 (13) and f2 (72) and not equivalent in pH 6.8 (factor f1 was 26 and f2 was 24). Drug release of ibuprofen at pH 1.2 was negligible due to its weak acid properties. Therefore, two in vivo bioequivalent tablets were declared bioinequivalent by this procedure, indicating that procedure seems to be over-discriminatory. PMID:22707831

  5. Chocolate consumption modulates cytokine production in healthy individuals.

    PubMed

    Netea, Stejara A; Janssen, Sam A; Jaeger, Martin; Jansen, Trees; Jacobs, Liesbeth; Miller-Tomaszewska, Gosia; Plantinga, Theo S; Netea, Mihai G; Joosten, Leo A B

    2013-04-01

    Epidemiological studies suggest that chocolate increases the incidence and severity of acne. Here we demonstrate that chocolate consumption primes human blood mononuclear cells from volunteers to release more interleukin-1β (IL-1β) and IL-10 upon stimulation with Propionibacterium acne or Staphylcoccus aureus, the two microorganisms involved in the pathogenesis of acne. In contrast, production of the Th17-derived cytokine IL-22 was inhibited by chocolate. Modulation of inflammation could represent an important mechanism through which chocolate consumption influences acne.

  6. 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

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... of patients with rheumatoid arthritis (RA). It also addresses additional considerations for...

  8. 78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration Over-the-Counter Ophthalmic Drug Products--Emergency Use... Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public... Webcast location will be posted on the Web page at http://www.fda.gov/Drugs/NewsEvents/ucm356526.htm...

  9. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  10. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  11. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  12. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  13. 21 CFR 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.132 Section 211.132 Food and Drugs FOOD AND DRUG ADMINISTRATION... over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has...

  14. 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.

  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.

  16. 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...

  17. 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

  18. 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

  19. 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

  20. Isotretinoin and acne--a study of relapses.

    PubMed

    Chivot, M; Midoun, H

    1990-01-01

    A study was carried out involving 172 patients with acne which warranted treatment with isotretinoin. Patients were followed up for between 12 and 41 months after discontinuation of treatment and the number of relapses was assessed. 37 patients (21%) relapsed. These relapses were correlated with patients' age, length of disease progression prior to treatment, total dose received, daily dose, duration of treatment and severity of acne. It appeared that only young age and severity of acne influenced the percentage of relapse.