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.

Quality of Life
Improvements in Acne QoL scores at week 12 in the 10-13 year age group were numerically greater for tazarotene 0.045% versus vehicle in 3 domains (self-perception, role-emotional, acne symptoms; Figure 6). In the 14-17-year age group, QoL score improvements at week 12 were numerically greater for tazarotene 0.045% versus vehicle in the role-social and acne symptoms domains. The greatest improvements were observed in the younger age group for the domains of self-perception and acne symptoms.

Adverse events and cutaneous safety and tolerability for the overall pooled population have been reported previously.19 In this post hoc analysis, in the 10-13 year and 14-17-year age groups, TEAEs were reported in 27.7% and 22.9% of tazarotene-treated patients versus 19.1% and 22.4% in vehicle-treated patients (Table 2). No treatment-related SAEs were reported in either age group. No TEAEs in the overall pediatric population occurred in more than 5% of patients. The most common TEAEs (>2% of the tazarotene-treated pediatric population [n=340]) were at the ap-