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 , Emil A. Tanghetti , Eric Guenin , Gina Martin , Radhakrishnan Pillai

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.