Tazarotene 0.045% Lotion for Moderate-to-Severe Acne in Male and Female Participants: A Phase II Post-hoc Analysis

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.

Keywords: Retinoid; acne; gender; sex; topical.

FIGURE 1.

Cryo-scanning electron microscopy of novel lotion formulation; from Tanghetti EA, Stein Gold L, Del Rosso JQ, et al. Optimized formulation for topical application of a fixed combination halobetasol/tazarotene lotion using polymeric emulsion technology. J Dermatolog Treat. 2019:1–8. Reprinted by permission of the publisher Informa UK Limited, trading as Taylor & Francis Ltd, http://www.tandfonline.com.

FIGURE 2.

Mean percent change in inflammatory lesions by sex (ITT population); A) male participants; B) female participants; no statistical analyses were conducted between tazarotene 0.045% lotion and combined vehicle, between tazarotene 0.045% lotion and tazarotene 0.01% cream, or between male and female participants. ITT: intent to treat.

FIGURE 3.

Mean percent change in noninflammatory lesions by sex (ITT population); A) male participants; B) female participants; no statistical analyses were conducted between tazarotene 0.045% lotion and combined vehicle, between tazarotene 0.045% lotion and tazarotene 0.01% cream, or between male and female participants. ITT: intent to treat.

FIGURE 4.

Least-squares mean percent change in lesions in tazarotene 0.045% lotion-treated male and female participants (ITT population). A) inflammatory lesions; B) noninflammatory lesions; *p<0.05 for tazarotene-treated female participants vs. male participants. ITT: intent to treat.

FIGURE 5.

Percentage of male and female participants with treatment success at Week 12 (ITT population); treatment success was defined as at least a two-grade reduction from baseline and a rating of "clear" or "almost clear" on the Evaluator’s Global Severity Scale. No statistically significant differences were found between tazarotene 0.045% lotion and combined vehicle. No statistically significant differences were found between tazarotene-treated males and females (0.045% lotion or 0.1% cream). ITT: intent to treat.