A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Clinical Study to Compare the Safety and Efficacy of a Novel Tazarotene 0.045% Lotion and Tazarotene 0.1% Cream in the Treatment of Moderate-to-Severe Acne Vulgaris

June 2019 | Volume 18 | Issue 6 | Original Article | 542 | Copyright © June 2019


Emil A. Tanghetti MD,a Leon H. Kircik MD,b Lawrence J. Green MD,c Eric Guenin PharmD PhD,d Susan Harris MS,e Gina Martin MOT,f Radhakrishnan Pillai PhDf

aCenter for Dermatology and Laser Surgery, Sacramento, CA bIndiana University School of Medicine, Indianapolis, IN, Physicians Skin Care, PLLC, Louisville, KY, Icahn School of Medicine at Mount Sinai, New York, NY cDepartment of Dermatology, George Washington University School of Medicine, Washington, DC dOrtho Dermatologics, Bridgewater, NJ eBausch Health, Bridgewater, NJ fBausch Health Americas, Inc., Petaluma, CA



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Treatment Success
Treatment success was defined as at least a 2-grade improvement in global severity by EGSS and ‘clear’ or ‘almost clear’. At week 12, 18.8% of patients achieved treatment success with tazarotene 0.045% lotion compared to 10.1% with combined vehicle (P=.148; Figure 4). Tazarotene 0.045% lotion showed a greater treatment success at week 12 when compared with tazarotene 0.1% cream (16.7%), but differences were not significant.

Subject Self-Assessment (SSA)
Tazarotene 0.045% lotion showed a greater numerical treatment success (‘clear’ or ‘almost clear’) at week 12 in terms of SSA when compared with tazarotene 0.1% cream (P=.768). Treatment success was achieved in 38.5% of patients, compared with 35.9% and 24.6% (tazarotene 0.01% cream and combined vehicle [P=.096], respectively).
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