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.




dryness, and exfoliation (Table 2). Application site irritation was reported in ≤1.2% of each race and ethnic subgroup.

Among tazarotene-treated participants who had cutaneous safety and tolerability signs and symptoms, most had mild or moderate severity at baseline and week 12 (Figure 6). Across all tazarotene-treated subgroups, there were transient increases in severity (primarily mild or moderate) at weeks 2 or 4 relative to baseline for several of the cutaneous safety and tolerability evaluations (data not shown). Investigator‑rated assessments indicated higher baseline rates (>20%) of hyperpigmentation in black participants and erythema in white, Hispanic, and non- Hispanic participants; however, all of these rates decreased by week 12. Patient‑reported tolerability assessments of itching, burning, and stinging were generally low in all subgroups, with itching tending to decrease and burning/stinging tending to increase from baseline to week 12.