Outpatient Acne Care Guideline
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Targeted Topical Delivery of Retinoids in the Management of Acne Vulgaris: Current Formulations and Novel Delivery Systems
pharmaceutics Review Targeted Topical Delivery of Retinoids in the Management of Acne Vulgaris: Current Formulations and Novel Delivery Systems Gemma Latter 1, Jeffrey E. Grice 2, Yousuf Mohammed 2 , Michael S. Roberts 2,3 and Heather A. E. Benson 1,* 1 School of Pharmacy and Biomedical Sciences, Curtin Health Innovation Research Institute, Curtin University, Perth 6845, Australia; [email protected] 2 Therapeutics Research Group, The University of Queensland Diamantina Institute, School of Medicine, University of Queensland, Translational Research Institute, Brisbane 4109, Australia; jeff[email protected] (J.E.G.); [email protected] (Y.M.); [email protected] (M.S.R.) 3 School of Pharmacy and Medical Sciences, University of South Australia, Basil Hetzel Institute for Translational Health Research, Adelaide 5011, Australia * Correspondence: [email protected]; Tel.: +61-8-9266-2338 Received: 19 August 2019; Accepted: 17 September 2019; Published: 24 September 2019 Abstract: Acne vulgaris is a common inflammatory pilosebaceous condition that affects 80–90% of adolescents. Since the introduction of tretinoin over 40 years ago, topical retinoid products have been a mainstay of acne treatment. The retinoids are very effective in addressing multiple aspects of the acne pathology as they are comedolytic and anti-inflammatory, and do not contribute to antibiotic resistance or microbiome disturbance that can be associated with long-term antibiotic therapies that are a common alternative treatment. However, topical retinoids are associated with skin dryness, erythema and pain, and may exacerbate dermatitis or eczema. Thus, there is a clear need to target delivery of the retinoids to the pilosebaceous units to increase efficacy and minimise side effects in surrounding skin tissue. -
Use of Undiluted Tea-Tree Oil As a Cosmetic
Federal Institute for Risk Assessment (BfR) Use of undiluted tea-tree oil as a cosmetic Opinion of the Federal Insitute for Risk Assessment (BfR), 1th September 2003 Background Recently there has been an increasing amount of reports on contact-allergic eczema in con- junction with the use of tea-tree oil. Tea-tree oil is sold as a pure natural product, highly con- centrated and undiluted in cosmetics. Tea-tree oil is advertised as a universal remedy al- though there is no marketing authorisation as a pharmaceutical product. Concentrated tea-tree oil has been classified as harmful according to the self-classification of the International Fragrance Association (IFRA) and is labelled with R-phrases R 22 (harmful if swallowed) R 38 (irritating to skin) and R 65 (may cause lung damage if swallowed) as well as the symbol Xn (harmful) (IFRA Labelling Manual 1, 2001). These indications of health hazards are also part of the safety data sheets of raw material suppliers. At the 65th and 66th meetings of the Cosmetics Committee at the Federal Institute for Risk Assessment (BfR), health risks associated with the use of undiluted and highly concentrated tea-tree oil in cosmetic products were discussed extensively. Result Tea-tree oil is a mixture of various terpenes extracted from the Australian tea-tree. Undiluted tea-tree oil is a pure natural product. In the presence of atmospheric oxygen but also when exposed to light and higher temperatures, oxidation processes occur leading to the formation of peroxides, epoxides and endoperoxides which have a sensitising potency and may trigger allergic skin reactions. -
Suppression of Prostate Tumor Cell Growth by Stromal Cell Prostaglandin D Synthase–Derived Products
Research Article Suppression of Prostate Tumor Cell Growth by Stromal Cell Prostaglandin D Synthase–Derived Products Jeri Kim,1 Peiying Yang,2 Milind Suraokar,3 Anita L. Sabichi,3 Norma D. Llansa,3 Gabriela Mendoza,3 Vemparalla Subbarayan,3 Christopher J. Logothetis,1 Robert A. Newman,2 Scott M. Lippman,3 and David G. Menter3 Departments of 1Genitourinary Medical Oncology, 2Experimental Therapeutics, and 3Clinical Cancer Prevention, The University of Texas M.D. Anderson Cancer Center, Houston, Texas Abstract seminal fluid (10). Once PGD2 is made, it forms derivative Stromal-epithelial interactions and the bioactive molecules compounds, most of which can transactivate the peroxisome g g produced by these interactions maintain tissue homeostasis proliferator–activated receptor (PPAR ). One PGD2 derivative, 15-deoxy-D12,14-prostaglandin J (15-d-PGJ ), can slow the growth and influence carcinogenesis. Bioactive prostaglandins pro- 2 2 duced by prostaglandin synthases and secreted by the prostate and induce the partial differentiation of selected cancer cells (12). D12,14 into seminal plasma are thought to support reproduction, but Another PGD2 derivative, 15-deoxy- -PGD2 (15-d-PGD2), has g their endogenous effects on cancer formation remain unre- also been shown to stimulate PPAR transactivation in RAW 264.7 solved. No studies to date have examined prostaglandin cell macrophage cultures as effectively as 15-d-PGJ2 (13). L-PGDS enzyme production or prostaglandin metabolism in normal also binds tritiated testosterone and may play a role in androgen prostate stromal cells. Our results show that lipocalin-type transport (14). In castrated rats, testosterone proprionate induces prostaglandin D synthase (L-PGDS) and prostaglandin D L-PGDS synthesis in the epididymis (15). -
Formulary Drug Removals
July 2018 Formulary Drug Removals Below is a list of medicines by drug class that have been removed from your plan’s formulary. If you continue using one of the drugs listed below and identified as a Formulary Drug Removal, you may be required to pay the full cost. If you are currently using one of the formulary drug removals, ask your doctor to choose one of the generic or brand formulary options listed below. Category Formulary Drug Formulary Options Drug Class Removals Allergies BECONASE AQ flunisolide spray, fluticasone spray, mometasone spray, triamcinolone spray, Nasal Steroids / Combinations OMNARIS DYMISTA QNASL ZETONNA Anticonvulsants ZONEGRAN carbamazepine, carbamazepine ext-rel, divalproex sodium, divalproex sodium ext-rel, gabapentin, lamotrigine, lamotrigine ext-rel, levetiracetam, levetiracetam ext-rel, oxcarbazepine, phenobarbital, phenytoin, phenytoin sodium extended, tiagabine, topiramate, valproic acid, zonisamide, FYCOMPA, OXTELLAR XR, TROKENDI XR, VIMPAT Anti-infectives, Antibacterials E.E.S. GRANULES erythromycins Erythromycins / Macrolides ERYPED Anti-infectives, Antibacterials MINOCIN minocycline Tetracyclines DORYX doxycycline hyclate DORYX MPC MONODOX Anti-infectives, Antibacterials MACRODANTIN nitrofurantoin Miscellaneous Anti-infectives, Antivirals VALCYTE valganciclovir Cytomegalovirus * Anti-infectives, Antivirals MAVYRET EPCLUSA (genotypes 1, 2, 3, 4, 5, 6), HARVONI (genotypes 1, 4, 5, 6), VOSEVI 1 Hepatitis C * DAKLINZA EPCLUSA (genotypes 1, 2, 3, 4, 5, 6), HARVONI (genotypes 1, 4, 5, 6) OLYSIO TECHNIVIE -
Moisturizer Use Enhances Facial Tolerability of Tazarotene 0.1% Cream Without Compromising Efficacy in Patients with Acne
Poster 101 Moisturizer Use Enhances Facial Tolerability of Tazarotene 0.1% Cream Without Compromising Efficacy in Patients With Acne Vulgaris Emil Tanghetti,1 Zoe Draelos,2 Pearl Grimes,3 Sunil Dhawan,4 Michael Gold,5 Leon Kircik,6 Lawrence Green,7 Angela Moore,8 Fran Cook-Bolden9 1Center for Dermatology and Laser Surgery, Sacramento, CA; 2Dermatology Consulting Services, High Point, NC; 3Vitiligo & Pigmentation Institute of Southern California, Los Angeles, CA; 4Center for Dermatology, Cosmetic and Laser Surgery, Fremont, CA; 5Tennessee Clinical Research Center, Nashville, TN; 6Physicians Skin Care PLLC, Louisville, KY; 7The George Washington University, Washington, DC; 8Arlington Center for Dermatology, Arlington, TX; 9The Skin Specialty Group, New York, NY • 6 months for systemic retinoids Table 1. Scale used to assess overall disease severity. • Mean levels of compliance were between “mostly compliant” and Efficacy Tolerability INTRODUCTION “very compliant” in both groups throughout the study. There were Score Overall disease severity no significant between-group differences in the degree of • The reduction in lesion counts with tazarotene + moisturizer was at • No adverse events considered probably or definitely related to treatment The use of any topical retinoid can involve a period of “retinization” in the first Treatment regimen 0 None—clear, no inflammatory lesions compliance. least as great as that with tazarotene alone at week 16: were reported. few weeks of treatment while the skin is adapting to the retinoid. During this • Patients were randomly assigned (on a 1:2 basis) to one of the following 1 Sparse comedones, with very few or no inflammatory lesions present period of acclimatization, some patients transiently experience dryness, – 57% vs. -
DF Fall 2019-Webready
A DERMATOLOGY FOUNDATION PUBLICATION SPONSORED BY ORTHO DERMATOLOGICS VOL. 38 NO. 2 FALL 2019 DDEERRMMAATTOOLLOOGGYY ™ Also In This Issue FOCUSFOCUS Janet Fairley, MD, New DF President: “DF support has profoundly advanced our specialty.” DF Clinical Symposia: Stiefel Scholar Cancer Research— Proceedings 2019–Part II Aiming to Normalize KC Cells Explaining that the child’s skin barrier has a structural defect enables ADVANCES IN DERMATOLOGY parents to understand the involvement of inadequate hydration, more bacteria, and increased penetration of antigens and allergens. Then The Dermatology Foundation presented its Maguiness explains the need to simultaneously treat the dehydrated annual 3-day cutting-edge CME symposia series skin, itch, inflammation, and infection, and teaches parents the entire earlier this year. Informal Breakfast Roundtables 2-week topical “eczema boot camp” routine: bleach baths, topical and evening Therapeutics Forums amplified the steroids, emollients, and wet wraps, typically done at home. She reassuringly likens a bleach bath to a swimming pool. Maguiness take-home value. Part II of the Proceedings includes described the procedures and benefits of bleach baths and wet wraps Therapeutic Updates; Diagnostic Dilemmas; and in detail, provided practical tips for gaining parental confidence and Medical Dermatology. (Part I, which appeared understanding, noted variations to the overall “boot camp” routine, and in the previous issue, included the Keynote talk discussed tapering. Then she shared her excitement about “entering -
Mechanisms of Action of Azelaic Acid 15% Gel: Assessing Its Broad Antioxidant and Comedolytic Effects Zoe Diana Draelos, MD
CCOSMETIOSMETICC CCONSULTATIONONSULTATION Mechanisms of Action of Azelaic Acid 15% Gel: Assessing Its Broad Antioxidant and Comedolytic Effects Zoe Diana Draelos, MD wo small studies were undertaken to investi- Dermatologic medications can have a similar versatility gate the ability of azelaic acid (AzA) 15% gel of action. For example, tetracyclines are used for their T to function as a comedolytic and as a topical antibacterial and anti-inflammatory qualities to treat antioxidant. The first study compared AzA 15% gel with acne. Sodium sulfacetamide and sulfur combinations are benzoyl peroxide (BPO) 5% gel as a comedolytic. Ten used for antibacterial, antifungal, and anti-inflammatory participants were randomized to apply AzA 15% gel on purposes for acne, seborrheic dermatitis, and rosacea. one shoulder and BPO 5% gel on the other shoulder One could argue that versatile ingredients can often be twice daily for 4 weeks, with a nontreated site on the more valuable than those that deliver a single, albeit central back serving as the control in all participants. powerful, effect. Comedone counts were obtainedCOS at baseline and week DERM4 An alternate dermatologic prescription that has mul- by examination of cyanoacrylate biopsies taken from tiple mechanisms of action is AzA 15% gel. Also known each site. The AzA 15% gel and BPO 5% gel produced as nonanedioic acid, AzA is a saturated dicarboxylic acid substantial decreases in mean comedones (12 to 0.9 and found naturally in wheat, rye, and barley. It is also pro- 14.9 to 1.6, respectively) from baseline to week 4 as duced by the yeast Pityrosporum ovale, a natural compo- compared with controlsDo (14.6 to 10.9). -
Comparing 2.5%, 5%, and 10% Benzoyl Peroxide on Inflammatory
Pharmacology and Therapeutics Comparing 2.5%, 5%, and 10% Benzoyi Peroxide on Inflammatory Acne Vulgaris OTTO H. MILLS, JR., PH.D., ALBERT M. KLICMAN, M.D., PH.D., PETER POCHI, M.D., AND HARRIET COMITE, M.D. From the Departments of Dermatology, University of Subjects, Materials, and Methods Pennsy/vania School of Medicine, Philadelphia, Pennsylvania, and Boston University School of Medicine, Clinical Studies Boston, Massachusetts The same methods were used to conduct three double- blind studies. After giving informed consent, subjects with mild to moderately severe inflammatory acne vulgaris of the face (minimum of 10 inflammatory lesions) were assigned to one of the three treatment groups. A total of 153 subjects, 74 men and 79 women (average age of 20 years), participated ABSTRACT: A 2.5% formulation of benzoyi peroxide was in the three studies. In the first, 25 subjects used 2.5% ben- compared with its vehicle, and with a 5% and a 10% proprietary zoyi peroxide gel and 25, the gel vehicle for this formulation. benzoyi peroxide gel preparation in three double-blind studies In the second, 26 used the 2.5 gel and 27, a 5% gel. The involving 153 patients with mild to moderately severe acne third study consisted of 25 subjects who used the 2.5% gel vulgaris. The 2.5% benzoyi peroxide formulation was more and 25, a 10% benzoyi peroxide gel. The subjects received effective than its vehicle and equivalent to the 5% and 10% no medications for any reasor\s during \he 4-week period concentrations in reducing the number of inflammatory lesions prior to the start of the study. -
TAZORAC® (Tazarotene) Gel 0.05% (Tazarotene) Gel 0.1%
NDA 020600 ® TAZORAC (tazarotene) Gel 0.05% (tazarotene) Gel 0.1% FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE DESCRIPTION TAZORAC® Gel is a translucent, aqueous gel and contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical dermatologic use only. The active ingredient is represented by the following structural formula: O OCH2CH3 N S TAZAROTENE C21H21NO2S Molecular Weight: 351.46 Chemical Name: Ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate Contains: Active: Tazarotene 0.05% or 0.1% (w/w) Preservative: Benzyl alcohol 1% (w/w) Inactives: Ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, carbomer 934P, edetate disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400, polysorbate 40, purified water, and tromethamine. CLINICAL PHARMACOLOGY Tazarotene is a retinoid prodrug which is converted to its active form, the cognate carboxylic acid of tazarotene (AGN 190299), by rapid deesterification in animals and man. AGN 190299 (“tazarotenic acid”) binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings is unknown. Psoriasis: The mechanism of tazarotene action in psoriasis is not defined. Topical tazarotene blocks induction of mouse epidermal ornithine decarboxylase (ODC) activity, which is associated with cell proliferation and hyperplasia. In cell culture and in vitro models of skin, tazarotene suppresses expression of MRP8, a marker of inflammation present in the epidermis of psoriasis patients at high levels. In human keratinocyte cultures, it inhibits cornified envelope formation, whose build-up is an element of the psoriatic scale. -
Long-Term Use of Spironolactone for Acne in Women: a Case Series of 403 Patients
Long-term use of spironolactone for acne in women: A case series of 403 patients Vaibhav Garg, BS,a JulianaK.Choi,MD,PhD,b William D. James, MD,b and John S. Barbieri, MD, MBAb Philadelphia, Pennsylvania Background: There are limited data regarding the long-term outcomes of spironolactone use for women with acne and its effect on truncal acne. Objective: To comprehensively describe outcomes of patients treated with spironolactone in routine clinical practice, including long-term outcomes. Methods: We performed a retrospective case series of 403 adult women treated for acne with spironolactone at an academic medical center between 2008 and 2019. Rates of objective, as assessed by Comprehensive Acne Severity Scale scores, and subjective acne clearance were evaluated, as well as rates of treatment discontinuation, dosage changes, and drug survival. Logistic regression was used to assess for association between incidence of menstrual adverse effects and combined oral contraceptive use. Results: As evaluated by Comprehensive Acne Severity Scale scores, at the first follow-up, 75.5%, 84.0%, and 80.2% of patients with available data had reduction or complete clearance of acne on the face, chest, and back, respectively. The mean drug survival was 470.7 days. Menstrual adverse effects were less common among those using combined oral contraception (odds ratio, 0.23; 95% confidence interval, 0.11-0.50). Limitations: This study was conducted at a single academic medical center. Conclusions: Spironolactone improves clinical outcomes and is well tolerated for many adult women with acne using it for an extended duration. ( J Am Acad Dermatol 2021;84:1348-55.) Key words: acne; acne vulgaris; birth control pill; combined oral contraceptive; comprehensive acne severity scale; oral antibiotics; outcomes; spironolactone. -
Therapeutic Drug Class
BUREAU FOR MEDICAL SERVICES WEST VIRGINIA MEDICAID EFFECTIVE PREFERRED DRUG LIST WITH PRIOR AUTHORIZATION CRITERIA 04/01/11 This is not an all-inclusive list of available covered drugs and includes only Version 2011.9 managed categories. Refer to cover page for complete list of rules governing this PDL. • Prior authorization for a non-preferred agent in any category will be given only if there has been a trial of the preferred brand/generic equivalent or preferred formulation of the active ingredient, at a therapeutic dose, that resulted in a partial response with a documented intolerance. • Prior authorization of a non-preferred isomer, pro-drug, or metabolite will be considered with a trial of a preferred parent drug of the same chemical entity, at a therapeutic dose, that resulted in a partial response with documented intolerance or a previous trial and therapy failure, at a therapeutic dose, with a preferred drug of a different chemical entity indicated to treat the submitted diagnosis. (The required trial may be overridden when documented evidence is provided that the use of these preferred agent(s) would be medically contraindicated.) • Unless otherwise specified, the listing of a particular brand or generic name includes all legend forms of that drug. OTC drugs are not covered unless specified. • PA criteria for non-preferred agents apply in addition to general Drug Utilization Review policy that is in effect for the entire pharmacy program, including, but not limited to, appropriate dosing, duplication of therapy, etc. • The use of pharmaceutical samples will not be considered when evaluating the members’ medical condition or prior prescription history for drugs that require prior authorization. -
1 EMA Tender EMA/2017/09/PE, Lot 2 Impact of EU Label
EMA tender EMA/2017/09/PE, Lot 2 Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: risk awareness and adherence Protocol • Prof. Anna Birna Almarsdóttir, Professor in Social and Clinical Pharmacy at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen • Prof. Marcel Bouvy, Professor of Pharmaceutical Care at the Division of Pharmacoepidemiology & Clinical Pharmacology of the Department of Pharmaceutical Sciences, Utrecht University. • Dr Rob Heerdink, Associate Professor at the Division of Pharmacoepidemiology & Clinical Pharmacology of the Department of Pharmaceutical Sciences, Utrecht University. • Dr Teresa Leonardo Alves, Researcher at the Centre for Health Protection, National Institute for Public Health and the Environment, The Netherlands. 1 Table of contents Background ...................................................................................................................... 3 Aims of the study ............................................................................................................. 4 Methods ........................................................................................................................... 4 Setting ........................................................................................... Error! Bookmark not defined. Study design ............................................................................................................................ 4 Population