Hilary E Baldwin1,2,3,4, Lawrence J Green1,2,3,4, Leon Kircik1,2,3,4, Eric Pierre Guenin1,2,3,4, Anya Loncaric Forest1,2,3,4, Radhakrishnan Pillai1,2,3,4. 1. Dr. Baldwin is with the Acne Treatment and Research Center in Brooklyn, New York, and Rutgers Robert Wood Johnson Medical Center in New Brunswick, New Jersey. 2. Dr. Green is with the Department of Dermatology at George Washington University School of Medicine in Washington, DC. 3. Dr. Kircik is with the Indiana University School of Medicine in Indianapolis, Indiana; Physicians Skin Care, PLLC, in Louisville, Kentucky; and the Icahn School of Medicine at Mount Sinai in New York, New York. 4. Dr. Guenin is with Ortho Dermatologics in Bridgewater, New Jersey. Ms. Forest and Dr. Pillai are with Bausch Health US, LLC in Petaluma, California.
Abstract
CLINICAL TRIALS ID: NCT02938494 BACKGROUND: In a Phase II study, tazarotene 0.045% lotion was statistically superior to vehicle and comparable to tazarotene 0.1% cream in reducing acne lesions, with fewer treatment-related adverse events (TEAEs) than the cream. OBJECTIVE: We analyzed data from the aforementioned study post-hoc to evaluate the effects of sex on treatment outcomes. METHODS:Participants aged 12 years or older with moderate-to-severe acne were randomized to tazarotene (0.045% lotion or 0.1% cream) or vehicle (lotion or cream) for 12 weeks of double-blind treatment. Outcomes analyzed in male and female subgroups included changes from baseline in inflammatory/noninflammatory lesions and TEAEs. RESULTS: In the intent-to-treat population (94 males and 116 females), reductions in lesion count were greater with tazarotene (lotion or cream) than with vehicle. In participants receiving tazarotene 0.045% lotion, the least-squares mean percent changes from baseline to Week 12 were greater in females than males, but the differences were not statistically significant (inflammatory [-70.3% vs. -56.2%]; noninflammatory [-60.0% vs. -53.2%]). In both females and males, the TEAE incidence was lower with tazarotene 0.045% lotion than 0.1% cream. CONCLUSION:Tazarotene 0.045% lotion substantially reduced acne lesions in both female and male participants. This newest tazarotene formulation might benefit patients who cannot tolerate older formulations or other topical retinoids. Given the relatively small size of this study, however, the results of this post-hoc analysis are intended to be exploratory in nature.
RCT Entities:
CLINICAL TRIALS ID: NCT02938494 BACKGROUND: In a Phase II study, tazarotene 0.045% lotion was statistically superior to vehicle and comparable to tazarotene 0.1% cream in reducing acne lesions, with fewer treatment-related adverse events (TEAEs) than the cream. OBJECTIVE: We analyzed data from the aforementioned study post-hoc to evaluate the effects of sex on treatment outcomes. METHODS:Participants aged 12 years or older with moderate-to-severe acne were randomized to tazarotene (0.045% lotion or 0.1% cream) or vehicle (lotion or cream) for 12 weeks of double-blind treatment. Outcomes analyzed in male and female subgroups included changes from baseline in inflammatory/noninflammatory lesions and TEAEs. RESULTS: In the intent-to-treat population (94 males and 116 females), reductions in lesion count were greater with tazarotene (lotion or cream) than with vehicle. In participants receiving tazarotene 0.045% lotion, the least-squares mean percent changes from baseline to Week 12 were greater in females than males, but the differences were not statistically significant (inflammatory [-70.3% vs. -56.2%]; noninflammatory [-60.0% vs. -53.2%]). In both females and males, the TEAE incidence was lower with tazarotene 0.045% lotion than 0.1% cream. CONCLUSION:Tazarotene 0.045% lotion substantially reduced acne lesions in both female and male participants. This newest tazarotene formulation might benefit patients who cannot tolerate older formulations or other topical retinoids. Given the relatively small size of this study, however, the results of this post-hoc analysis are intended to be exploratory in nature.
Authors: Joshua A Zeichner; Hillary E Baldwin; Fran E Cook-Bolden; Lawrence F Eichenfield; Sheila Fallon-Friedlander; David A Rodriguez Journal: J Clin Aesthet Dermatol Date: 2017-01-01
Authors: Leon H. Kircik; Linda Stein Gold; Kenneth Beer; Hilary Baldwin; Eric Guenin; Robert Kang; Johnson Varughese Journal: J Drugs Dermatol Date: 2020-08-01 Impact factor: 2.114
Authors: Maria Cecilia Rivitti Machado; Edileia Bagatin; Thais Helena Proença de Freitas; Maria Cecília Rivitti-Machado; Beatriz Medeiros Ribeiro; Samanta Nunes; Marco Alexandre Dias da Rocha Journal: An Bras Dermatol Date: 2019 Jan-Feb Impact factor: 1.896
Authors: Emil A Tanghetti; Linda Stein Gold; James Q Del Rosso; Tina Lin; Arturo Angel; Radhakrishnan Pillai Journal: J Dermatolog Treat Date: 2019-09-26 Impact factor: 3.359