Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials

January 2020 | Volume 19 | Issue 1 | Original Article | 70 | Copyright © January 2020


Published online December 13, 2019

Emil A. Tanghetti MDa, William P. Werschler MDb Terry Lain MD,c Eric Guenin PharmD PhD MPH,d Gina Martin MOT,E Radhakrishnan Pillai PhDe

aCenter for Dermatology and Laser Surgery, Sacramento, CA bUniversity of Washington, School of Medicine, Seattle, WA cUniversity of Texas MD Anderson Cancer Center, Houston, TX dOrtho Dermatologics, Bridgewater, NJ eBausch Health Americas, Inc., Petaluma, CA





of subjects in the tazarotene 0.045% lotion groups achieved at least a 2-grade improvement in EGSS at week 12 compared with 15.2% and 20.9% with vehicle (both P<0.001).

Lesion Counts
Tazarotene 0.045% lotion was significantly more effective than vehicle in achieving a reduction in lesion counts (Figure 3 and 4). At week 12, the absolute reduction (15.6, Study 1 and 16.7, Study 2) in inflammatory lesion count relative to baseline for the tazarotene 0.045% lotion group was significantly greater than for vehicle (12.4, Study 1 and 13.4, Study 2, P<0.001 both studies). Correspondingly, the absolute reduction (21.0, Study 1 and 24.6, Study 2) in noninflammatory lesion count relative to baseline for the tazarotene 0.045% lotion group was significantly greater than for vehicle (16.4, Study 1 and 16.6, Study 2, P<0.001 both studies).

By week 12, there was a 55.5% and 51.4% (Study 1) change in inflammatory and noninflammatory lesion counts from baseline (LS mean), and a 59.5% and 60.0% change in Study 2, respectively, compared with 45.7% and 41.5% (Study 1, both P<0.001) and 49.0% and 41.6% (Study 2, both P<0.001) with vehicle.

Percent changes in noninflammatory lesions were statistically significant compared with vehicle from week 2 (Study 2, P=0.018) or week 4 (Study 1, P=0.004) and changes in inflammatory lesions statistically significantly greater at week 8 (P≤0.006) Acne-Specific QoL

At baseline, the mean scores for each domain were similar. By Week 12 improvements in QoL (mean absolute changes) were consistently greater in the groups treated with tazarotene 0.045% lotion. Absolute change from baseline in Self-Perception, Role-Emotional, Role-Social and Acne Symptom domains were 7.5, 6.0, 4.7, and 6.4, respectively, compared with 6.7, 5.5, 4.1, and 5.3 for subjects treated with vehicle. Safety Evaluation Overall, 26.8% (N=209) of subjects treated with tazarotene 0.045% lotion reported AEs compared with 19.1% (N=151) with