"53779 Fixed-Combination Halobetasol Propionate 0.01%/Tazarotene 0.045%" by Linda Stein-Gold, Edward Lain et al.
 

53779 Fixed-Combination Halobetasol Propionate 0.01%/Tazarotene 0.045% and Halobetasol Propionate 0.01% Lotions for Plaque Psoriasis on Lower Extremities With Body Hair

Document Type

Conference Proceeding

Publication Date

9-1-2024

Publication Title

J Am Acad Dermatol

Abstract

Background: Fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) and HP 0.01% lotions are indicated for plaque psoriasis in adults. The efficacy and safety of HP/TAZ and HP in hair-bearing areas are not well understood. This post hoc analysis of pivotal phase 3 trials of participants with moderate-to-severe plaque psoriasis evaluated a subgroup of males with target plaques on the leg. Methods: Participants applied HP/TAZ (n=276) or vehicle (n=142 [NCT02462122, NCT02462070]); or HP (n=285) or vehicle (n=145 [NCT02514577, NCT02515097]) once daily for 8 weeks and were assessed at weeks 2, 4, 6, 8, and 12. Endpoints included treatment success (≥2-grade improvement from baseline in investigator’s global assessment [IGA] and IGA score of 0 or 1); treatment success of target lesion (≥2 grade improvement from baseline score in erythema, scaling, and plaque elevation); and safety. Results: Rates of treatment success were significantly greater at weeks 4 through 12 for HP/TAZ (n=87) and HP (n=91) vs vehicle (n=50 and 48, respectively; P≤0.01 for both HP/TAZ and HP vs vehicle). Target plaques receiving either HP/TAZ or HP vs placebo exhibited significantly higher rates of treatment success of erythema, scaling, and elevation at weeks 4 through 8 (P<0.05 for both HP/TAZ and HP vs vehicle). Forty two and 19 participants reported treatment-emergent adverse events in HP/TAZ- and HP-treated groups, respectively. Conclusions: This post hoc analysis demonstrates that HP/TAZ and HP lotions are effective and safe at treating plaque psoriasis of the leg on males, a body area historically difficult to treat due to the presence of hair.

Volume

91

Issue

3

First Page

AB217

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