15211 Treatment of moderate to severe acne with once-daily tazarotene 0.045% lotion in males: Pooled analysis of two phase 3 studies

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Conference Proceeding

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J Am Acad Dermatol


Acne vulgaris has been reported in 85% of adolescents, with moderate to severe acne occurring more frequently in adolescent/adult males than females. Tazarotene is a potent topical retinoid for acne treatment, but irritation with existing formulations may limit its use. An innovative tazarotene 0.045% lotion formulation was developed by utilizing polymeric emulsion technology. In two phase 3, double-blind, vehicle-controlled 12-week studies, eligible patients aged ≥9 years with moderate to severe acne were randomized (1:1) to receive once-daily tazarotene 0.045% lotion or vehicle. Data for male patients were summarized descriptively at week 12 in this analysis. Efficacy assessments included reductions in inflammatory/noninflammatory lesion counts and percent of patients achieving ≥2-grade reduction in Evaluator Global Severity Scores (EGSS) and a clear/almost clear score (treatment success). Adverse events (AEs) and cutaneous safety/tolerability were also assessed. Of 1614 total pooled participants, 550 were males (n = 268 tazarotene 0.045%; n = 282 vehicle). Changes from baseline in absolute lesion counts were higher with tazarotene (least-squares mean [standard deviation] inflammatory: −15.9 [10.5]; noninflammatory −22.4 [16.1]) versus vehicle (−11.3 [10.5]; −14.4 [17.8]). More patients achieved treatment success with tazarotene (25.1%) versus vehicle (12.7%). The percent of males reporting treatment-emergent AEs (TEAEs) was similar between tazarotene (19.0%; 50/263) and vehicle (19.3%; 53/275). In both groups, most TEAEs were of mild-moderate severity. Serious AEs occurred in 1 patient in each group (not treatment-related). The most common administration-related TEAE was application site pain (2.7% tazarotene; 0% vehicle). The novel tazarotene 0.045% lotion was efficacious and well tolerated in male patients with moderate to severe acne.





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