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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Patient Satisfaction (PSS) and Quality of Life
There were no significant differences in PSS mean scores at week 12 between tazarotene 0.045% lotion and tazarotene 0.1% cream (P=.372) or combined vehicle (P=.242). Overall, patients treated with tazarotene 0.045% lotion assessed their treatment satisfaction higher than tazarotene 0.1% cream (mean score of 7.7 versus 7.4).
There were also no statistically significant differences in the improvement between treatment groups based on the meanAcne-QoL assessments in each of the 4 evaluated domains. Improvements in self-perception, role-emotional, and role-social were similar with tazarotene 0.045% lotion and tazarotene 0.1% cream, and markedly greater than those achieved in the combined vehicle groups. In terms of acne symptoms improvement, the absolute change from baseline with tazarotene 0.045% lotion was again greater than that achieved with the combined vehicle, however tazarotene 0.1% cream only demonstrated an improvement similar to that achieved with vehicle.