Fixed-Combination Halobetasol Propionate/Tazarotene Lotion for Psoriasis in Patients With 3%–5% Affected Body Surface Area

August 2021 | Volume 20 | Issue 8 | Original Article | 829 | Copyright © August 2021


Published online August 1, 2021

Emil A. Tanghetti MD,a Neal Bhatia MD,b Scott Drew DO,c Abby Jacobson MS PA-Cd

aCenter for Dermatology and Laser Surgery, Sacramento, CA
bTherapeutics Clinical Research, San Diego, CA
cDermatology Associates of Mid-Ohio, Marion, OH
dOrtho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ

Abstract
Introduction: Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement.
Methods: In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigator’s global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (≥2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of ≥4 points on dermatology life quality index (DLQI).
Results: Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (P< .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P< .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; P< .05). More participants achieved a ≥2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, P< .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare.
Conclusions: In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life.

J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217

INTRODUCTION

Psoriasis is a chronic inflammatory skin disease characterized by raised erythematous plaques with silvery scales.1 Psoriasis is common, affecting ~2% of the population, and is associated with reduced quality of life (QOL).1,2 Identification of patients with mild as opposed to moderate or severe psoriasis is complex.3 Furthermore, multiple studies have found that patients who are considered to have mild psoriasis nonetheless experience greatly impaired QOL because of ongoing symptoms such as pruritus and because of the shame and social rejection associated with visible skin lesions.4-7

Topical agents are the mainstay of treatment for mild-to-moderate psoriasis, including treatment of patients with lower levels of body surface area (BSA) involvement who are not candidates for systemic therapy.3,8 However, safety concerns associated with topical corticosteroids, including skin atrophy and adrenal suppression, limit their long-term use.8,9 Tachyphylaxis is also experienced by some patients with extended, >12-week topical steroid use.8 Combining the retinoid tazarotene with a potent or super-potent topical corticosteroid, such as halobetasol propionate, is recommended for patients with mild-to-moderate disease.8 Halobetasol propionate/Tazarotene may provide synergistic effectiveness, increase the duration of remission, and reduce adverse events (AEs), especially those associated with independent use of halobetasol propionate and tazarotene, including skin atrophy and irritation.8,10,11
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