Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials

October 2018 | Volume 17 | Issue 10 | Original Article | 1062 | Copyright © 2018

Lawrence J. Green MD,a Francisco A. Kerdel MD,b Fran E. Cook-Bolden MD,c Jerry Bagel MD,d Tina Lin PharmD,e Gina Martin MOT,f Radhakrishnan Pillai PhD,f Robert Israel MD,g Tage Ramakrishna MDg

aGeorge Washington University School of Medicine, Washington, DC bFlorida Academic Dermatology Centers, Miami, FL cSkin Specialty Dermatology and Department of Dermatology, Mount Sinai Hospital Center, New York, NY dPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ eOrtho Dermatologics, Bridgewater, NJ fDow Pharmaceutical Sciences Inc., Petaluma, CA gBausch Health, Bridgewater, NJ

Abstract

BACKGROUND: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. METHODS: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ‘clear’ or ‘almost clear’) at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. RESULTS: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%. LIMITATIONS: Study did not include subjects with BSA greater than 12. CONCLUSIONS: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.

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INTRODUCTION

Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population.1-3 The use of topical therapy is a key component in the management of almost all psoriasis patients. Topicals are considered first-line therapy for mild disease and are having an increasing role in moderate-to-severe psoriasis.4The use of topical corticosteroids (TCS) is commonplace, mainly due to their immunosuppressive, anti-inflammatory, and anti-proliferative properties. Treatment guidelines suggest their use as monotherapy in mild-to-moderate psoriasis; or in combination with other topical agents, ultraviolet light, or systemic agents in moderate-to-severe disease.4 However, long-term safety concerns remain, particularly with more potent formulations due to increased risk of local cutaneous adverse events (AEs); including skin atrophy, telangiectasia, and infrequently, hypothalamic–pituitary–adrenal (HPA) axis suppression.4-6 Consequently, super potent TCS such as halobetasol propionate (Ultravate® 0.05%, Ranbaxy Laboratories, Inc., Jacksonville, FL) cream are not recommended for more than two consecutive weeks’ use.Formulation advances may provide comparable efficacy, with reduced concentration of active ingredients and a correspondingly improved safety profile that can extend a product's utility. The

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