New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis

June 2020 | Volume 19 | Issue 6 | Original Article | 602 | Copyright © June 2020

Published online May 8, 2020

Lawrence F. Eichenfield MD,ª Emil A. Tanghetti MD,b Eric Guenin PharmD PhD MPH,c Gina Martin MOT,d Radhakrishnan Pillai PhDd

ªDepartments of Dermatology and Pediatrics; University of California, San Diego School of Medicine and Rady Children's Hospital, San Diego, CA bCenter for Dermatology and Laser Surgery, Sacramento, CA cOrtho Dermatologics*, Bridgewater, NJ dBausch Health US, LLC*, Petaluma, CA *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

was a 55.6% reduction in mean percent change from baseline in inflammatory lesion counts in tazarotene-treated patients aged 10-13 years, compared with a 37.0% reduction in the vehicle arm (P<0.01; Figure 3). Among tazarotene-treated patients 14-17 years of age, mean percent inflammatory lesion count reduction was 53.3% compared with a 41.2% reduction with vehicle (P<0.001). At week 8, there was also a significant reduction in mean percent inflammatory lesion counts in the tazarotene 0.045% lotion group versus vehicle among patients 14-17 years of age (43.6% vs 34.6%, P=0.004; Figure 3). Mean percent reductions in noninflammatory lesion counts were significantly greater with tazarotene 0.045% than with vehicle in both age groups at weeks 4, 8, and 12 (P<0.05, all; Figure 4). Improvement in acne lesions are shown in Figure 5.

When comparing tazarotene-treated patients in both age groups, there were no statistically significant differences in lesion count reductions or percent of patients achieving treatment success at any timepoint.