Clinical Profile of Halobetasol Propionate 0.01%/ Tazarotene 0.045% Lotion in Patients With Hyperkeratotic Plaque Psoriasis

Abstract

Background: Hyperkeratotic psoriatic plaques, characterized by considerable elevation and scaling, present treatment challenges with topical therapy. This post hoc analysis of two phase 3 trials evaluated the efficacy and tolerability of fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ; indicated for the topical treatment of plaque psoriasis in adults) in treating hyperkeratotic plaques.

Methods: Participants received HP/TAZ or vehicle daily for 8 weeks, with a 4-week posttreatment follow-up. Multiple subpopulations represented patients with hyperkeratotic plaques. Analysis 1 included a subgroup with severe plaque elevation and a second subgroup with severe scaling. Analysis 2 included a subgroup with either an investigator's global assessment (IGA) of 3 with moderate-to-severe plaque elevation or an IGA of 4. Endpoints included plaque elevation and/or scaling success (greater than or equal to 2-grade improvement for either) and safety assessments.

Results: At week 8, the severe plaque elevation subgroup and severe scaling subgroup achieved plaque elevation and scaling success, respectively, at significantly greater rates with HP/TAZ versus vehicle (P<0.05 for all; Analysis 1). Analysis 2 participants achieved significantly greater rates of plaque elevation and scaling success with HP/TAZ versus vehicle at week 8 (P less than or equal to 0.001 for all). Tolerability improved from baseline by >46% for all subgroups. Adverse events were similar between treatment groups.

Conclusion: HP/TAZ was efficacious and well tolerated for treating hyperkeratotic plaques.

Citation: Tanghetti E, Stein Gold L, Lain E, Jacobson A. Clinical profile of halobetasol propionate 0.01%/tazarotene 0.045% lotion in patients with hyperkeratotic plaque psoriasis. J Drugs Dermatol. 2025;24(6):590-598. doi:10.36849/JDD.8720R1.