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.
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