Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis

March 2017 | Volume 16 | Issue 3 | Original Article | 234 | Copyright © 2017

David Pariser MD,a Michael Bukhalo MD,b Scott Guenthner MD,c Steven Kempers MD,d Stephen Shideler MD,e Linda Stein Gold MD,f Eduardo Tschen MD MBA,g Jim Berg,h Mary Beth Ferdon PhD,h and Syd Dromgoole PhDh

aVirginia Clinical Research, Inc., Norfolk, VA bAltman Dermatology Associates, Arlington Heights, IL cThe Indiana Clinical Trials Center, PC, Plainfield, IN dMinnesota Clinical Study Center, Fridley, MN eForefront Dermatology, Carmel, IN f Henry Ford Health System, Detroit, MI gAcademic Dermatology Associates, Albuquerque, NM hTherapeutics, Inc., San Diego, CA

Abstract

BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis. OBJECTIVE: Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis. METHODS: Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment “success” defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator’s Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions. RESULTS: After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment “success” (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups. CONCLUSIONS: The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.

J Drugs Dermatol. 2017;16(3):234-240.

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INTRODUCTION

Psoriasis, a chronic autoimmune disease manifested as inflammatory dermatosis, affects 1-3% of the United States population and 0.5-4.6% of the worldwide population.Plaque psoriasis, the most common form of the disease, is characterized by well-demarcated, pruritic, thick, elevated, scaly skin lesions.1,2 Although there is no cure for psoriasis, medical treatments strive to control existing disease and reduce the associated signs and symptoms. Topical corticosteroids, because of their marked antiin ammatory, antiproliferative, antipruritic, and immunosuppressive activities, are a cornerstone in psoriasis and other refractory dermatoses treatments.3,4 Topical corticosteroids, available in many strengths and formulations, are the most widely used treatment option for plaque psoriasis and are preferred over systemic therapy because they can be applied directly to affected sites and have less systemic risk due to limited absorption through the skin.1,5 Halobetasol propionate, a trihalogenated molecule, is a super-potent Class I topical corticosteroid with a history of over 25 years of clinical use.6 In the United States, halobetasol

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