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.




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).