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

June 2025 | Volume 24 | Issue 6 | 590 | Copyright © June 2025


Published online May 30, 2025

doi:10.36849/JDD.8720R1

Emil Tanghetti MDa, Linda Stein Gold MDb, Edward Lain MDc, Abby Abby PA-Cd

aCenter for Dermatology and Laser Surgery, Sacramento, CA
bHenry Ford Health System, West Bloomfield, MI
cAustin Institute for Clinical Research, Austin, TX
dBausch Health Companies Inc, Bridgewater, NJ

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

INTRODUCTION

Hyperkeratotic psoriatic plaques are associated with treatment difficulty and enhanced disease burden. For instance, patients with elevated plaques are less likely to achieve skin clearance with topical corticosteroids (TCSs) than patients with less plaque elevation.1 Additionally, by obstructing light penetration, severe scaling may limit response to phototherapy.2 Furthermore, patients with moderate-to-severe scaling experience poorer quality of life than patients without scaling.3

Because of their rapid action and safety when used in accord- ance with current guidelines, TCSs are a mainstay of psoriasis treatment.4,5 Treatment with an ultra-high potency TCS (eg, halobetasol propionate [HP, potent-to-superpotent]) is recommended for thick plaques.5 The retinoid tazarotene (TAZ) can supplement and reduce TCS use and mitigate the risk of steroid-associated adverse events, although pruritis and irritation may occur with TAZ monotherapy.5-7 Additionally, TAZ causes a reduction of inflammation and normalization of keratinocyte differentiation and proliferation, which may contribute to resolving hyperkeratosis.5,8 Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) leverages the rapid onset of TCS action and immunogenetic mechanisms of TAZ to reduce keratinocyte proliferation while also mitigating TCS- and TAZ-associated adverse event risk.9 The addition of TAZ to HP increases TCS effectiveness, minimizes steroid exposure, and optimizes maintenance of psoriasis remission.5,9,10 Further, the complementary mechanisms of HP and TAZ, including anti-inflammatory action and reduction in keratinocyte hyperproliferation, suggest that HP/TAZ may ameliorate hyperkeratosis.9

Hyperkeratotic plaques require an efficacious and well-tolerated therapy that reduces scaling and elevation. In the authors' clinical experience, HP/TAZ shows particular efficacy for hyperkeratotic plaques; however, clinical data supporting this observation are needed. To investigate the utility of HP/TAZ,