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

August 2019 | Volume 18 | Issue 8 | Original Article | 790 | Copyright © August 2019

Neal Bhatia MD,a Linda Stein Gold MD,b Leon H. Kircik MD,c Rhonda Schreiber MSd

aTherapeutics Clinical Research, San Diego, CA bHenry Ford Health System, Detroit, MI cIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC; Skin Sciences, PLLC, Louisville, KY dMayne Pharma, LLC, Raleigh, NC

Abstract
Background: A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low application shear that allows for easier coverage over large and/or hirsute areas than existing formulations.

Objective: To determine the safety and effectiveness of HBP-Foam in subjects with plaque psoriasis.

Methods: Two randomized, double-blind, vehicle-controlled clinical studies were conducted in 560 adult subjects with moderate to severe plaque psoriasis. Subjects applied the assigned test article to all psoriatic plaques twice daily for 14 days. The key efficacy measures were the proportion of subjects with “treatment success,” defined as those subjects that achieved a score of 0 (clear) or 1 (almost clear) and at least a two-grade improvement compared to baseline for the Investigator’s Global Assessment (IGA) and for the clinical signs of psoriasis (plaque elevation, scaling, and erythema) as well as pruritus. Safety measurements included adverse events and local skin reactions in the treatment area.

Results: HBP-Foam was statistically superior to vehicle in achieving “Treatment Success” in 25.3% and 30.7% vs 3.9% and 7.4% (P<0.001) in Studies 1 and 2, respectively. Pruritus scores statistically improved by over 30% in HBP-Foam treated subjects. In addition, these subjects experienced a significant reduction in the clinical signs of psoriasis (plaque elevation, scaling, and erythema). In contrast, in the vehicle groups the decrease in psoriasis-related signs was generally not observed. Safety outcomes were unremarkable and similar in both the HBP-Foam and vehicle treatment groups.

Conclusions: These results demonstrate the safety and effectiveness of HBP-Foam in the treatment of plaque psoriasis. Furthermore, this novel foam formulation has demonstrable for its ease of application over large and/or hairy treatment areas.

ClinicalTrials.gov Registration: NCT02742441 NCT02368210
J Drugs Dermatol. 2019;18(8):790-796.

INTRODUCTION

Psoriasis is a chronic immune mediated disease of inflammatory dermatosis that affects 3.2% of adults in the United States and leads to a significant reduction in quality of life.1 The most common type of psoriasis is plaque psoriasis, which is characterized in moderate to severe disease by well-demarcated erythematous scaly plaques. Psoriasis pathogenesis involves the abnormal regulation of the cells of the immune system (white blood cells including T lymphocytes, neutrophils, and other leucocytes) prompted by both environmental and genetic factors, which leads to a dysregulation of normal keratinocyte proliferation and an increase in proinflammatory cell signals.4,5

Although there is no cure for psoriasis, medical treatments can control existing disease and reduce the associated signs and symptoms. Topical formulations are the most widely used treatment option for localized plaques.2,3,6 Historically, topical corticosteroids have been the most commonly used drugs for the treatment of psoriasis and other refractory dermatoses because of their marked anti-inflammatory, antiproliferative, antipruritic, and immunomodulatory activities.7

Halobetasol propionate (HBP) is a super-potent Class I topical corticosteroid for the treatment of dermal diseases with a history of over 25 years of clinical use. HBP (chemically known as 21- chloro-6α, 9-difluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17- propionate) is a trihalogenated molecule, which increases its anti-inflammatory and antiproliferative