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 MD,a Jonathan S. Weiss MD,b Neil Sadick MD,c Fran E. Cook-Bolden MD,d Stephen K. Tyring MD PhD,e Eric Guenin PharmD PhD MPH,f Anya Loncaric MS,g 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.

DISCUSSION





This pooled, post hoc analysis of two phase 3 trials demonstrated that tazarotene 0.045% lotion applied once daily for 12 weeks improved acne symptoms and was well tolerated, regardless of race or ethnicity. Compared with vehicle lotion, treatment with tazarotene 0.045% lotion resulted in significant reductions in inflammatory and noninflammatory lesions and treatment success at week 12 in white, Hispanic, and non-Hispanic subpopulations. In black participants receiving tazarotene 0.045% lotion, there was a significant decrease in noninflammatory lesions compared with vehicle lotion. In all subpopulations, there were improvements in inflammation-associated sequelae of acne, including hyperpigmentation.

Clinical trials with topical retinoids have demonstrated efficacy for acne treatment in skin of color, but concerns remain on tolerability of some agents and formulations.11,18,19 Our findings provide support for the use of tazarotene 0.045% lotion in the understudied setting of skin of color and concur with smaller