Once-Daily Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Sex

Abstract

Background: Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex. Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 ["clear"] or 1 ["almost clear"]), and treatment-emergent adverse events (TEAEs). Results: A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory: females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory: females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P<0.001, all). The percentage of participants achieving treatment success at week 12 was also significantly higher with tazarotene 0.045% lotion versus vehicle in females and males (P<0.001, both). Compared with tazarotene-treated males, tazarotene-treated females had significantly greater changes from baseline in inflammatory and noninflammatory lesions and a greater proportion achieved treatment success at week 12 (P<0.05, all). TEAE rates were similar between tazarotene-and vehicle-treated males; rates were higher for tazarotene-treated females than vehicle-treated females. Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in the treatment of moderate-to-severe acne in female and male participants.

The Right Formula for Acne: Importance of Vehicle Formulation in Tazarotene 0.045% Lotion Design, Application, Tolerability, and Efficacy

“…Study participants treated with tazarotene 0.045% lotion experienced signifcantly greater reductions from the baseline in infammatory and noninfammatory lesion counts and signifcantly greater rates of treatment success (≥2-grade reduction (improvement) in Evaluator's Global Severity Score and "clear" or "almost clear" skin) than those treated with vehicle [37,42,43]. Subsequent post hoc analyses have demonstrated efcacy and tolerability of tazarotene 0.045% lotion among phase 3 study participants grouped by sex, race, ethnicity, and age [44][45][46][47][48][49]. An additional post hoc analysis based on skin type demonstrated that most participants who self-reported oily skin at the baseline also reported improvement to "moderately oily" or "low/not oily" skin [50].…”

New medications for the treatment of acne

“…6 Females treated with tazarotene 0.05% lotion demonstrated greater improvement from baseline than males, though efficacy was demonstrated in both. 7 In pooled analysis examining the efficacy and tolerability of tazarotene 0.045% lotion by race and ethnicity, White, Hispanic, and non-Hispanic participants all had significant reductions in inflammatory and noninflammatory lesions. 8 Another examination of pooled phase 3 data demonstrated that younger participants, both male and female, had greater improvements in treated versus vehicle groups than older participants.…”