Cumulative Irritation Potential of Adapalene 0.1% Cream and Gel Compared with Tazarotene Cream 0.05% and 0.1%

Total Page:16

File Type:pdf, Size:1020Kb

Cumulative Irritation Potential of Adapalene 0.1% Cream and Gel Compared with Tazarotene Cream 0.05% and 0.1% THERAPEUTICS FOR THE CLINICIAN Cumulative Irritation Potential of Adapalene 0.1% Cream and Gel Compared With Tazarotene Cream 0.05% and 0.1% Jonathan S. Dosik, MD; Kenneth Homer, MS; Stéphanie Arsonnaud Despite the many beneficial effects of dermato- The mean 21-day cumulative irritancy indices for logic applications, most of the current treatments adapalene 0.1% cream and gel were significantly for acne cause local irritation. The objective of lower (Pϭ.05) than those for tazarotene cream this study was to compare the ability of the epi- 0.05% and 0.1% and not notably higher than that of dermis to tolerate adapalene 0.1% cream and gel the negative control product. and tazarotene cream in concentrations of 0.05% Cutis. 2005;75:289-293. and 0.1%. A total of 30 subjects were enrolled in the study. The test products were applied under occlusive dressings at randomized sites on the cne vulgaris is the most common dermato- upper back for approximately 24 hours, 4 times logic disorder, affecting approximately 85% a week, and for 72 hours, once a week, for a A of individuals at some time between the ages period of 3 weeks. Skin reactions (erythema of 12 and 14 years.1 Although acne is most preva- score plus other local reactions) at the product lent in this age group, the disease is reported in application sites were assessed 15 to 30 minutes 8% of adults between the ages of 25 and 34 years after dressing removal. and in 3% of adults between the ages of 35 and Twenty-six subjects completed the study. A 44 years. In the United States alone, more than total of 16 subjects discontinued use of 1 or 50 million people are estimated to be affected by more of the test products because of irritation some form of acne, with over 17 million experiencing scores reaching severe or greater; all but one of acne vulgaris. Acne is the most common dermato- these discontinuations were at sites treated with logic disorder—almost always diagnosed by the the tazarotene products. subject—and counts for 20% of all dermatologic consultations.1 Currently, there is no single topical antiacne medication that acts against all 4 of the Accepted for publication November 24, 2004. major pathophysiologic features of acne: hyperker- Dr. Dosik and Mr. Homer are from TKL Research, Inc, Paramus, atinization, sebum production, bacterial prolifera- New Jersey. Ms. Arsonnaud is from Galderma R&D, Inc, Cranbury, New Jersey. tion, and inflammation. Despite the many Dr. Dosik receives research grants from Galderma R&D, Inc. beneficial effects of dermatologic applications, Mr. Homer is an employee of TKL Research, Inc, which was under retinoids and their derivatives cause local irrita- contract with Galderma R&D, Inc. Ms. Arsonnaud is an employee tion, which is manifested as erythema and peeling of Galderma R&D, Inc. This study was supported by a research of the stratum corneum.2 grant from Galderma R&D, Inc. Reprints: Stéphanie Arsonnaud, Galderma R&D, Inc, Adapalene, a naphthoic acid derivative with 5 Cedar Brook Dr, Cranbury, NJ 08512 retinoid activity, is effective in the treatment of mild (e-mail: [email protected]). to moderate acne vulgaris. Adapalene gel 0.1% VOLUME 75, MAY 2005 289 Therapeutics for the Clinician has been shown to be better tolerated than several tazarotene formulations.3-7 Table 1. Tazarotene is a receptor-selective retinoid. It normalizes keratinocyte differentiation, reverses Classification of Irritation keratinocyte hyperproliferation, and has anti- inflammatory effects. Tazarotene cream 0.1% has Mean Cumulative Product shown potential for irritation, erythema, peeling, Irritancy Index Classification dryness, burning, and itching.8 A new concentra- Ͻ tion of 0.05% of tazarotene cream recently was 0.025 Nonirritating made available to limit these side effects to the 0.025–1 (noninclusive) Slightly irritating level of those for the 0.1% concentration of ada- palene cream and gel. Ͼ1–2 (noninclusive) Moderately irritating This present study was designed to compare the Ͼ2–3 (noninclusive) Very irritating irritation potential of adapalene 0.1% cream and gel with 2 different concentrations of tazarotene cream, 0.05% and 0.1%. White petrolatum served as a neg- ative control. Cumulative irritancy assays currently are used to Table 2. assess the irritation potential of topically applied materials. Potential irritation is caused by direct Demographics and damage to the epidermal cells; no immunologic Subject Disposition (allergic) mechanisms are involved.7 Results from this standard assay are widely accepted to be indica- Nϭ30 tors of irritation.9 Age, y Methods MeanϮSD 50.9Ϯ13.0 The study was conducted in accordance with the Range 24–75 principles of the Declaration of Helsinki and its amendments and in compliance with good clinical Gender, n (%) practice. Before entering the study, approval from an Female 27 (90.0) independent review board was obtained, and all sub- Male 3 (10.0) jects provided written informed consent. Population—Subjects of any gender and race, Race, n (%) aged at least 18 years, and with Fitzpatrick photo- White 26 (86.7) type I to IV were included in the study.10 Female Hispanic 4 (13.3) subjects had to have a negative urine pregnancy test at the beginning of the study. No. of subjects Subjects with a known history of atopic dermati- who discontinued, n (%) 4 (13.3) tis, eczema, or psoriasis or with known sensitivities At subject’s request 1 (3.3) to any ingredients in the test products were excluded Lost to follow-up 2 (6.7) from the study. Nonrespect of washout period 1 (3.3) In addition, subjects who did not conform to the washout period of between 1 and 12 weeks for No. of subjects topical and systemic medications (eg, oral cortico- who completed, n (%) 26 (86.7) steroids, nonsteroidal anti-inflammatory drugs, salicylic acid Ͼ1 g/d, any oral retinoids) were excluded from the study. Study Design—The design of this study is stan- applications of study products to healthy subjects dard for the determination of the 21-day cumulative meeting specific inclusion and exclusion criteria. irritancy assay. The use of comparative treatments To ensure the completion of 25 subjects, a total and a negative control product provided appropriate of 30 subjects were selected. All subjects received control in the study. repeated applications of each of the study products This was a single-center, active-controlled and on the upper back under occlusive dressings for a negative-controlled, investigator-blinded, intra- period of 3 weeks. The primary parameter of interest individual comparison study, with randomized was an assessment of cumulative product irritancy, 290 CUTIS® Therapeutics for the Clinician Table 3. Mean Cumulative Irritancy Index (MCII) by Tested Products Differences Adapalene Tazarotene Tazarotene White Study Products MCIIϮSD Gel 0.1% Cream 0.05% Cream 0.1% Petrolatum Adapalene cream 0.1% 0.06Ϯ0.11 Ϫ0.12 Ϫ0.74* Ϫ1.06* 0.03 Adapalene gel 0.1% 0.18Ϯ0.47 Ϫ0.62* Ϫ0.94* 0.15 Tazarotene cream 0.05% 0.80Ϯ0.54 Ϫ0.33* 0.77* Tazarotene cream 0.1% 1.12Ϯ0.54 1.09* White petrolatum 0.03Ϯ0.05 *P≤.01. scores were carried forward to the 2.5 end of the study. Adapalene cream 0.1% Test Products—Product appli- Adapalene gel 0.1% cations were performed at the 2.0 Tazarotene cream 0.05% investigational site. Five zones, Tazarotene cream 0.1% each with a surface of about 4 cm2 White petrolatum 1.5 in diameter, were selected on the upper back of each subject, avoid- ing any moles, hairs, or nonflat 1.0 areas. On initiation, each of the Mean Score products was applied randomly to one of the zones on the upper 0.5 back according to a predefined randomization schedule. 0.0 All efforts were made to keep the evaluator blinded to the iden- 14 15 012345678910111213 tification of the products applied. Reading Number Thus, the individual applying and removing the product was differ- Figure 1. Mean individual treatment score for local tolerance by reading number. ent from the individual evaluating the sites. The randomization list was kept from the evaluator. based on visual grading of erythema and other local Each zone was delineated with a cutaneous skin reactions at the application sites. marker. The zones were designated by the numbers At each visit, following the initial dressing appli- 1, 2, 3, 4, and 5 on one side of the spine. About cation, skin reactions were assessed 15 to 30 minutes 0.2 g of each product (adapalene 0.1% cream or gel, after removal of the product. When an erythema tazarotene cream 0.05% or 0.1%, and white petro- reaction related to a product received a score of 3 latum) was applied, under an occlusive dressing (severe) at 1 or more sites, product applications at the (large Finn Chambers, a system that protects skin incriminated sites were discontinued. Likewise, if an from rubbing against clothing), by a qualified mem- irritation reaction related to the adhesive prohibited ber of the study site to its designated zone. dressing at a particular site, all product applications at Dressings were applied at each visit and the incriminated sites were discontinued, and the removed at the subsequent visit, approximately VOLUME 75, MAY 2005 291 Therapeutics for the Clinician 24 hours later. Those applied on Friday were left on for 72 hours Adapalene Tazarotene over the weekend and removed gel 0.1% cream 0.05% the following Monday. Furthermore, subjects were asked to avoid exposure to the sun, including sunbathing or White Tazarotene other excessive exposure or UV petrolatum cream 0.1% radiation (eg, tanning parlors); to avoid using any cosmetics on the study zone; and to avoid bathing Adapalene or showering the upper back.
Recommended publications
  • 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.
    [Show full text]
  • Cumulative Irritation Comparison of Adapalene Gel and Solution with 2 Tazarotene Gels and 3 Tretinoin Formulations
    THERAPEUTICS FOR THE CLINICIAN Cumulative Irritation Comparison of Adapalene Gel and Solution With 2 Tazarotene Gels and 3 Tretinoin Formulations Alan Greenspan, MD; Christian Loesche, MD; Nancy Vendetti; Kathleen Georgeian; Richard Gilbert, PhD; Michel Poncet, PhD; Michael D. Baker, BS; Pascale Soto, RPh Forty-two subjects with normal skin were enrolled gel 0.025%, and 1 discontinued adapalene in a single-center study to assess the cumula- gel 0.1%. None of the subjects discontinued use tive irritancy potential of adapalene (Differin® of the white petrolatum or the adapalene solu- gel 0.1% and Differin solution 0.1%) compared tion 0.1%. Adapalene gel and solution 0.1% with tazarotene (Tazorac® gels 0.05% and 0.1%), were statistically (PϽ.01) less irritating than tretinoin (Retin-A Micro® gel 0.1%, Avita® cream both tazarotene gels 0.1% and 0.05%, tretinoin 0.025%, and Avita gel 0.025%), and white petro- microsphere gel 0.1%, and tretinoin gel 0.025%, latum (negative control). All test materials were and they were not statistically different from applied randomly, under occlusion, to sites tretinoin gel 0.025%. located on either side of the midline— the mid Cutis. 2003;72:76-81. thoracic area of the subjects’ backs. All patches were applied daily, Monday through Friday, to dapalene (Differin®) is a naphthoic-acid the same sites, unless the degree of reaction to derivative with retinoid activity that is a test product or adhesive necessitated removal A effective in the treatment of mild to moder- (grade 3). ate acne vulgaris.1-4 Adapalene, in both gel and Thirty-eight of the 42 subjects (90.5%) com- cream formulations, at the marketed and approved pleted the study.
    [Show full text]
  • Outpatient Acne Care Guideline
    Outpatient Acne Care Guideline Severity Mild Moderate Severe < 20 comedones or < 20-100 comedones or 15-50 > 5 cysts, >100 comedones, or inflammatory lesions inflammatory lesions >50 inflammatory lesions Initial Treatment Initial Treatment Initial Treatment Benzoyl Peroxide (BP) or Topical Combination Therapy Combination Therapy Topical Retinoid Retinoid + BP Oral antibiotic or OR + (Retinoid + Antibiotic) + BP Topical retinoid Topical Combination Therapy or + BP + Antibiotic Retinoid + (BP + Antibiotic) or OR BP Retinoid + BP Oral antibiotic + topical retinoid + +/- or BP Topical antibiotic Retinoid + Antibiotic + BP or Topical Dapsone IF Inadequate Response IF Inadequate Response IF Inadequate Consider dermatology Response referral Change topical retinoid Consider changing oral concentrations, type and/or antibiotic formulation AND or Add BP or retinoid, if not already Change topiocal combination Consider isotretinoin prescribed therapy Consider hormone therapy or and/or (females) Change topical retinoid Add or change oral antibiotic concentrations, type and/or or formulation Consider isotretinoin Additional Considerations or Consider hormone therapy (females) Change topical comination Previous treatment/history Side effects therapy Costs Psychosocial impact Vehicle selection Active scarring Ease of use Regimen complexity Approved Evidence Based Medicine Committee 1-18-17 Reassess the appropriateness of Care Guidelines as condition changes. This guideline is a tool to aid clinical decision making. It is not a standard of care. The physician should deviate from the guideline when clinical judgment so indicates. GOAL: Pediatricians should initiate treatment for cases of “Mild” to “Severe” acne (see algorithms attached). Pediatricians should also counsel patients in order to maximize adherence to acne treatment regimens: 1. Realistic expectations. Patients should be counseled that topical therapies typically take up to 6-8 weeks to start seeing results.
    [Show full text]
  • 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.
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • Tazarotene Topical Gel 0.1%
    Contains Nonbinding Recommendations Draft Guidance on Tazarotene This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Tazarotene Dosage Form; Route: Gel; topical Recommended Studies: One study Type of study: Bioequivalence study with clinical endpoint Design: Randomized, double blind, parallel, placebo controlled, in vivo Strength: 0.1% Subjects: Males and nonpregnant, nonlactating females with acne vulgaris Additional comments: Specific recommendations are provided below. ______________________________________________________________________________ Analytes to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (90% CI): Clinical endpoint Waiver request of in vivo testing: Not applicable Dissolution test method and sampling times: Not applicable Applicants intending to propose an alternative approach by which to demonstrate bioequivalence should refer to the guidance for industry Controlled Correspondence Related to Generic Drug Development and the guidance for industry Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA for additional information describing the procedures on how to clarify regulatory expectations regarding your individual drug development program. Additional comments regarding the bioequivalence study with clinical endpoint: 1. The Office of Generic Drugs recommends conducting a single bioequivalence study with clinical endpoint in the treatment of acne vulgaris comparing the tazarotene topical gel, 0.1% test product versus the reference product and placebo control, each applied once daily in the evening for 12 weeks.
    [Show full text]
  • Topical Tazarotene Products
    Drug and Biologic Coverage Policy Effective Date ............................................ 9/1/2021 Next Review Date… ..................................... 9/1/2022 Coverage Policy Number ............................... IP0174 Topical Tazarotene Products Table of Contents Related Coverage Resources Overview .............................................................. 1 Clascoterone – (IP0173) Medical Necessity Criteria ................................... 1 Topical Acne – Non-Retinoid Products (IP0166) Reauthorization Criteria ....................................... 3 Topical Acne – Retinoid Products (IP0167) Authorization Duration ......................................... 3 Topical Adapalene Products – (IP0181) Conditions Not Covered....................................... 3 Topical Azelaic Acid Products – (IP0172) Background .......................................................... 3 Topical Rosacea Products – (IP0003) Topical Trifarotene – (IP0180) References .......................................................... 4 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of
    [Show full text]
  • 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
    [Show full text]
  • Topical Tazarotene Gel, 0.1%, As a Novel Treatment Approach For
    1 1 PLAN OF THESIS 2 3 4 MICRONEEDLING VERSUS TOPICAL TAZAROTENE 0.1% GEL FOR THE 5 TREATMENT OF ATROPHIC POST ACNE SCARRING - A RANDOMIZED 6 CONTROLLED STUDY 7 8 9 SUBMITTED IN PARTIAL FULFILLMENT OF THE DEGREE 10 11 OF 12 13 MD (DERMATOLOGY, VENEREOLOGY AND LEPROLOGY) 14 15 OF THE 16 17 POST-GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH 18 CHANDIGARH 19 20 BY 21 22 23 DR.AFRA T P 24 25 JUNIOR RESIDENT 26 DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROLOGY 27 PGIMER, CHANDIGARH 28 29 30 31 GUIDE: 32 33 DR TARUN NARANG 34 35 ASSISTANT PROFESSOR 36 DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROLOGY 37 PGIMER, CHANDIGARH 38 39 40 CO-GUIDE: 41 42 DR SUNIL DOGRA 43 44 ADDITIONALPROFESSOR 45 DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROLOGY 46 PGIMER, CHANDIGARH Downloaded From: https://jamanetwork.com/ on 09/23/2021 2 47 48 49 INDEX 50 51 52 Summary of the Proposed Research 3-4 Review of Literature 5-24 Aims and Objectives 25 Materials and Methods 26-33 Statistical analysis 34 Ethical Justification 35 Bibliography 36-42 Annexure I Consent form 43 Annexure II Study Proforma 44-46 Annexure III Patient Information Sheet 47-51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 Downloaded From: https://jamanetwork.com/ on 09/23/2021 3 68 SUMMARY OF THE PROPOSED RESEARCH 69 70 Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It manifests clinically 71 as non-inflammatory (open and closed comedones) or inflammatory (papules, pustules and 72 nodules) lesions.
    [Show full text]
  • Aetna Formulary Exclusions Drug List
    Covered and non-covered drugs Drugs not covered – and their covered alternatives 2020 Advanced Control Plan – Aetna Formulary Exclusions Drug List 05.03.525.1B (7/20) Below is a list of medications that will not be covered without a Key prior authorization for medical necessity. If you continue using one of these drugs without prior approval, you may be required UPPERCASE Brand-name medicine to pay the full cost. Ask your doctor to choose one of the generic lowercase italics Generic medicine or brand formulary options listed below. Preferred Options For Excluded Medications1 Excluded drug name(s) Preferred option(s) ABILIFY aripiprazole, clozapine, olanzapine, quetiapine, quetiapine ext-rel, risperidone, ziprasidone, VRAYLAR ABSORICA isotretinoin ACANYA adapalene, benzoyl peroxide, clindamycin gel (except NDC^ 68682046275), clindamycin solution, clindamycin-benzoyl peroxide, erythromycin solution, erythromycin-benzoyl peroxide, tretinoin, EPIDUO, ONEXTON, TAZORAC ACIPHEX, esomeprazole, lansoprazole, omeprazole, pantoprazole, DEXILANT ACIPHEX SPRINKLE ACTICLATE doxycycline hyclate capsule, doxycycline hyclate tablet (except doxycycline hyclate tablet 50 mg [NDC^ 72143021160 only], 75 mg, 150 mg), minocycline, tetracycline ACTOS pioglitazone ACUVAIL bromfenac, diclofenac, ketorolac, PROLENSA acyclovir cream acyclovir (except acyclovir cream), valacyclovir ADCIRCA sildenafil, tadalafil ADZENYS XR-ODT amphetamine-dextroamphetamine mixed salts ext-rel†, dexmethylphenidate ext-rel, dextroamphetamine ext-rel, methylphenidate ext-rel†, MYDAYIS,
    [Show full text]
  • Acitretin; Adapalene; Alitretinoin; Bexarotene; Isotretinoin
    21 June 2018 EMA/261767/2018 Updated measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids On 22 March 2018, the European Medicines Agency (EMA) completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids (those taken by mouth). Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin. They are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including severe acne and psoriasis. Some retinoids are also used to treat certain forms of cancer. The review confirmed that oral retinoids can harm the unborn child and must not be used during pregnancy. In addition, the oral retinoids acitretin, alitretinoin and isotretinoin, which are used to treat conditions mainly affecting the skin, must be used in accordance with the conditions of a new pregnancy prevention programme by women able to have children. Topical retinoids (those applied to the skin) must also not be used during pregnancy, and by women planning to have a baby. More information is available below. Regarding the risk of neuropsychiatric disorders, the limitations of the available data did not allow to clearly establish whether this risk was due to the use of retinoids. However, considering that patients with severe skin conditions may be more vulnerable to neuropsychiatric disorders due to the nature of the disease, the prescribing information for oral retinoids will be updated to include a warning about this possible risk.
    [Show full text]