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.





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.

Safety
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-