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.




with tazarotene 0.045% lotion versus vehicle for all racial and ethnic subpopulations. At week 12, a significantly higher proportion of participants achieved treatment success with tazarotene 0.045% lotion compared with vehicle in the white, Hispanic, and non-Hispanic groups (P<0.05, all; Figure 5). Although a higher proportion of black participants achieved treatment success with tazarotene 0.045% lotion compared with vehicle, this difference was not significant. The size of black population subgroup may be responsible for the lack of statistical significance.

Safety
Rates of TEAEs were similar across the tazarotene 0.045% lotion- treated racial and ethnic subgroups (range, 20.2%–28.7%; Table 2). Overall, TEAE incidence was lower in the vehicletreated groups compared with tazarotene. None of the SAEs were deemed related to treatment by study investigators. Most TEAEs were mild-moderate in severity; the incidence of moderate TEAEs was highest in white and the non-Hispanic subpopulations, regardless of treatment. The incidence of treatment-related TEAEs ranged from 9.8%–12.4% among the tazarotene 0.045% lotion-treated racial and ethnic subgroups. The most common TEAEs were related to application site pain,