Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race/Ethnicity

July 2020 | Volume 19 | Issue 7 | Original Article | 727 | Copyright © July 2020


Published online June 22, 2020

Neal Bhatia MDa, Jonathan S. Weiss MDb, Neil Sadick MDc, Fran E. Cook-Bolden MDd, Stephen K. Trying MD PhDe, Eric Guenin PharmD PhD MPHf, Anya Loncaric MSg, Susan Harris MSh

aTherapeutics Clinical Research, San Diego, CA bGeorgia Dermatology Partners, and Gwinnett Clinical Research Center, Inc., Snellville, GA cWeill Cornell Medical College, New York, NY; Sadick Dermatology, New York, NY dFran E. Cook-Bolden, MD, PLLC; Mount Sinai Hospital Center, New York, NY EUniversity of Texas Health Science Center, Houston, TX fOrtho Dermatologics,* Bridgewater, NJ gBausch Health US, LLC,* Petaluma, CA hBausch Health US, LLC,* Bridgewater, NJ *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Abstract
Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials.
Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of ‘clear’ or ‘almost clear’). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated.
Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12.
Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125

INTRODUCTION

Acne vulgaris is one of the most common dermatologic conditions for which all patients seek treatment, including those with darker skin tones.1 Given the growing non-white population, estimated to be nearly one-half of the United States population by 2050,2 more information is needed regarding the effects of acne treatment in all skin types. Recent articles highlighting the treatment of acne in Asian patients,3 Hispanic patients,4 and women of color5 have set the stage for understanding how race and ethnicity might affect treatment outcomes. In all skin types, acne development has the same causes: follicular hyperkeratinization, increased sebum production, proliferation of Cutibacterium acnes (formerly Propionibacterium acnes) bacteria on the skin surface, and inflammation.6,7 More highly pigmented skin can have properties that increase the risk of acne and inflammation-related sequalae.6 These sequelae occur in 50%-75% of black women with acne and include dyspigmentation and scarring.8,9 Post-inflammatory hyperpigmentation (PIH) can be associated with acne resolution or irritation from harsh treatments or skin care.10-12 For many