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.

plication site (pain [n=17; 5.0%], dryness [n=9; 2.6%], erythema [n=7; 2.1%] and pruritus [n=7; 2.1%]); viral upper respiratory tract infection was also reported in 4.7% of pediatric patients though none of these instances were deemed related to treatment. Rates of application site irritation were low (0.6%).

The majority of the ratings for cutaneous safety and tolerability, including hypopigmentation and hyperpigmentation, were either 0 (none) or 1 (mild) in both age groups at week 12; in the tazarotene-treated 14-17 year age group, 1 patient reported severe burning and 1 reported severe stinging (Figure 7). For nearly all cutaneous safety and tolerability evaluations, there were transient increases in severity (primarily mild or moderate) following treatment with tazarotene 0.045% at weeks 2, 4, and 8 relative to baseline; however, by week 12 the percentage of patients with ratings of “none” were similar to or greater than baseline values. The exception was for scaling in the 14-17-year age group, in which 217 (83.8%) reported “none” at week 12 versus 257 (93.5%) at baseline (Figure 7).