DOCSLIB.ORG

Topical Tazarotene Gel, 0.1%, As a Novel Treatment Approach For

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read 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. The major brunt of the disease is borne by adolescents aging 16-20 years as 73 shown by a study in India1. Scarring as a sequel to acne can occur in up to 95% of acne patients 74 and 30% may develop cosmetically disfiguring scarring.2 75 Various factors have a role in the causation of acne. The major ones are increased sebum 76 production, hypercornification of pilosebaceous duct, abnormal colonization of pilosebaceous 77 unit by Propionibacterium acnes and inflammation. The uninhibited inflammatory process in 78 acne initiate the process of wound healing with the granulation tissue formation and remodeling 79 of extracellular matrix.3 Depending on the activity and balance between the components 80 involved in the process, there can be a net loss or gain of collagen forming atrophic or 81 hypertrophic scars respectively.4 Thus the inflammatory process associated with acne lead to post 82 acne scarring. 83 Jacob et al classified atrophic acne scars as icepick (60%–70% ), rolling(15%–25%) and boxcar 84 (20%–30%) depending on their shape.5 For the ease of identification and stratification of 85 severity, atrophic acne scars are graded by different scales, of which the most popular ones are 86 the qualitative scale and the quantitative scale proposed by Goodman and Baron.6, 7 87 Eventhough acne scarring is permanent, the appearance can be improved with various medical, 88 laser, surgical and tissue augmentation techniques. Topical retinoids are the mainstay of medical 89 management for macular post acne scars. They reduce epidermal melanin by inhibiting the action 90 of tyrosinase and and also by reduction of melanosome transfer to keratinocytes. Retinoids also 91 normalizes keratinocyte differentiation, reduces the inflammation and stimulates collagen 92 synthesis.8, 9 Topical tazarotene is therapeutically effective as 0.1% gel or 0.1% cream.10, 93 11Tazarotene (0.1%) gel was found to be superior to adapalene (0.1%) and tretinoin (0.025%, 12 94 0.1%) for the treatment of acne vulgaris. Based on its mechanism of action and role in collagen Downloaded From: https://jamanetwork.com/ on 09/23/2021 4 95 synthesis, topical tazarotene is a logical choice to investigate for the management of atrophic 96 post acne scars. 97 Among the procedural methods, microneedling with dermaroller is a novel and promising 98 option. It is a minimally invasive procedure for the management of atrophic acne scars.13 It 99 causes per-cutaneous collagen induction by augmenting the natural process of wound healing.14 100 There are studies establishing the efficacy of newer dermatosurgical technique, the 101 microneedling in atrophic post acne scar management.15, 16 The efficacy of topical tazarotene in 102 the management of acne vulgaris and reducing PIH has been proved in previous published 103 studies.12, 17This is a pilot study comparing microneedling and topical tazarotene for the 104 treatment of atrophic post acne scarring in regard to extent and rapidity of improvement, patient 105 satisfaction and any adverse events if any. 106 107 108 109 110 111 112 113 114 115 116 117 118 119 Downloaded From: https://jamanetwork.com/ on 09/23/2021 5 120 121 Introduction 122 Acne vulgaris is one of the most common dermatoses in the world. It is a chronic inflammatory 123 disease of the pilosebaceous unit. Majority of the incidence of acne is seen in adolescence. Acne 124 occurs over the seborrheic areas like face and trunk. It may manifest clinically as non 125 inflammatory (open and closed comedones) or inflammatory (papules, pustules and nodules) 126 lesions. The inflammatory process associated with acne may lead to post acne scarring and is 127 common sequelae. Scarring occurs due to gain or loss of collagen with resultant formation of 128 hypertrophic or atrophic scarring respectively. Scarring is a distressing phenomenon and is most 129 unwelcome when it occurs on the face. Severe scarring on the face is physically disfiguring and 130 causes significant psychological distress. The affected individual may suffer from lack of self 131 confidence, low self-esteem and many other psychological ill effects. Even though post acne 132 facial scarring is a challenging problem to manage there are various methods to improve the 133 appearance of scar. 134 Epidemiology 135 Acne is an almost universal condition in younger people. Acne usually starts in the early teens 136 near puberty with the onset of facial sebum production and facial comedones followed by 137 inflammatory lesions. Acne lesions usually develop earlier in females as puberty occurs earlier in 138 them. The major brunt of the disease is borne by the age group 16-20 years as shown by a study 139 in India.1 Mean age of onset was 15.97 years, affecting males more than females. Prevalence of 140 acne in age group of 12-17 years is 50-60% in boys and 38-73% in girls by a study in India.1 141 Scarring as a sequel to acne can occur in up to 95% of acne patients and 30% may develop 142 cosmetically disfiguring scarring.2 143 Pathogenesis 144 Pathogenesis of Acne 145 Acne is a multifactorial disease. The four basic factors which have been identified include: (i) 146 sebaceous gland hyperactivity and seborrhea (ii) abnormal follicular differentiation and Downloaded From: https://jamanetwork.com/ on 09/23/2021 6 147 hyperkeratinization of the pilosebaceous duct, (iii) abnormal colonization of the pilosebaceous 148 duct with microbial flora especially P. acnes and (iv) increased inflammation. 149 1. Sebaceous gland hyperactivity and seborrhea: 150 Increased production of sebum by sebaceous glands leads to development of acne.18 151 Triglycerides and lipoperoxides in sebum have an active role in acne formation. Free fatty acids 152 formed by the breakdown of triglycerides promote colonization of P.acnes, cause inflammation 153 and is comedogenic.19 Lipoperoxides produce proinflammatory cytokines and stimulate the 154 peroxisome proliferator-activated receptor (PPAR) pathway, increasing sebum production.20 155 Androgenic hormones such as testosterone and more active DHT also have a significant role in 156 acne pathogenesis. These hormones act on the sebocytes and regulate their proliferation and 157 differentiation.21 Corticotropin releasing hormone also has a role and it is seen that corticotropin 158 releasing hormone receptors are increased in the sebocytes of patients with acne.22 159 2. Comedogenesis : 160 Follicular epidermis including that of the infundibulum becomes hyperproliferative and the 161 corneocytes become increasingly cohesive with the formation of a plug in the follicular ostium. 162 The plug so formed further causes collection of keratin, sebum and bacteria in the follicle and 163 dilation of the upper hair follicle producing a microcomedone. 164 Keratinocyte hyperproliferation is stimulated by DHT, subnormal levels of linoleic acid, 165 increased interleukin 1 alpha (IL-1) activity and effects of P.acnes.23, 24 Fibroblast growth factor 166 receptor (FGFR)- 2 pathway also causes proliferation of corneocytes and is androgen 167 dependent.25 168 Ductal hyperkeratinisation is seen histologically as microcomedones and clinically as 169 blackheads, whiteheads and other forms of comedones such as macrocomedones .The number 170 and size of follicular casts (micro-comedones) correlates with acne severity.26 171 3. Colonization of Intrafollicular duct with P.acnes : 172 P.acnes is a Gram-positive, anaerobic, and microaerobic bacterium found in the pilosebaceous 173 follicle. Colonization of intrafollicular duct with P.acnes has significant role in comedogenesis 174 and initiating inflammation. The breakdown of triglycerides into free fatty acids by P.acnes Downloaded From: https://jamanetwork.com/ on 09/23/2021 7 175 further promotes its colonization resulting in comedogenesis .19The carbohydrate antigen present 176 in the cell wall of P.acnes causes antibody development whose titres correlates with severity of 177 acne.27 178 4. Inflammation: 179 The microcomedone formed by follicular plugging further expand by accumulation
Load more

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]
  • 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]
  • 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]
  • Clinical Experience Utilizing Topical Combination of Benzoyl Peroxide 5
    Clinical Focus: Acne Clinical Experience Utilizing Topical Combination of Benzoyl Peroxide 5%/Clindamycin 1% and Retinoids The use of a fixed combination clindamycin/benzoyl peroxide formulation in conjunction with topical retinoids addresses multiple elements of the pathophysiology of acne. By Joseph B. Bikowski, MD se of combinations of different classes of topi- Benzoyl peroxide 5%clindamycin phosphate 1% cal products—frequently antimicrobials and (BPO/CP, Duac® Topical Gel, Stiefel Laboratories, Inc.) retinoids—is common in the management of is such a product. This once-daily, fixed-combination Uacne vulgaris. This article provides background moisturizing gel has demonstrated significantly on the benefits of different classes of anti-acne med- improved efficacy and tolerability compared with its ications and reviews data supporting their use in com- individual components.2,3 Consensus guidelines rec- bination to complement three case reports of patients ommend the use of a retinoid either alone or in com- treated with benzoyl peroxide 5%/clindamycin phos- bination with BPO and/or a topical antibiotic for phate 1% gel in combination with a retinoid. Clinical mild-to-moderate inflammatory acne, and for most improvement is noted by photographic and physician comedonal acne, except for very severe disease.4,5 The assessments at baseline and follow-up visits. combination of BPO/CP and a topical retinoid pro- vides optimal synergism of agents. While each of Introduction these agents has some degree of anti-inflammatory Acne has a multifactorial pathogenesis including seba- activity, and both antibiotics and BPO decrease ceous gland hyperplasia, follicular hyperkeratiniza- Propionibacterium acnes (P. acnes) proliferation, tion, microbial proliferation, immune reactions, and retinoids are the only anti-acne agents that normalize inflammation.1 There is a variety of agents available keratinization.1,5,6 By using these agents together, the for the treatment of acne, including topical and sys- benefits of each overlap, thereby maximizing efficacy.
    [Show full text]
  • 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.
    [Show full text]
  • A Comparative Study of Efficacy of Once Daily 0.1% Tazarotene and Adapalene Gel for the Treatment of Facial Acne Vulgaris
    Original Research A Comparative Study of Efficacy of once Daily 0.1% Tazarotene and Adapalene Gel for the Treatment of Facial Acne Vulgaris Mukunda Ranga Swaroop Associate Professor, Adichunchanagiri Institute of Medical Sciences, Mandya, Karnataka Email: [email protected] ABSTRACT Background: Acne is a self-limiting chronic inflammatory disorder of pilo- sebaceous follicles seen among young adults with significant psychological and social impact. Tretinoin which was widely used for many years is being replaced gradually by newer generation agents like Tazarotene and Adapalene which unlike Tretinoin are specific for a subset of retinoic acid receptors. Objectives: To compare the efficacy of once daily topical 0.1% Tazarotene and Adapalene gel in the treatment of mild to moderate facial acne vulgaris. Method: A total number of 60 patients with mild to moderate facial acne vulgaris attending out-patient department of Dermatology, Venereology and Leprosy from Oct.2004 – April. 2006 were studied. Patients were allocated alternately to group A and group B. Group A received 0.1% Tazarotene gel and group B patients received 0.1% Adapalene gel and were advised to apply topically once daily in the evening. Patients were followed up on 4th, 8th and 12th week. Results: At the 4thweek of post treatment evaluation, the non-inflammatory lesions (comedones) responded early to Tazarotene 0.1% gel than to Adapalene 0.1% gel. At the end of 12th week treatment period, Tazarotene 0.1% gel had an overall superiority to Adapalene 0.1% gel as an antiacne agent. Conclusion: The results of the study show that Tazarotene 0.1% gel is a better anticomedogenic agent with rapid rate of clinical improvement when compared with Adapalene 0.1% gel.
    [Show full text]