Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05%

March 2016 | Volume 15 | Issue 3 | Original Article | 334 | Copyright © 2016

Linda Stein Gold MD,a J. Mark Jackson MD,b Melissa L.F. Knuckles MD,c,d and Jonathan S. Weiss MDe

aHenry Ford Medical Center, Detroit, MI
bUniversity of Louisville, Division of Dermatology, Louisville, KY
cUniversity of Louisville, Louisville, KY
dPikeville School of Osteopathic Medicine, Pikeville, KY
eGwinnett Dermatology, Snellville, GA

Abstract

BACKGROUND: A novel formulation of 0.05% betamethasone dipropionate in an emollient spray vehicle (DFD-01) was developed to deliver steroid to the skin layers most affected by psoriasis.
OBJECTIVE: To compare the efficacy and safety of DFD-01 to its vehicle for the treatment of moderate plaque psoriasis over 4 weeks.
METHODS: Two Phase 3 trials enrolled adults with moderate psoriasis (Investigator Global Assessment [IGA]=3; 10–20% body surface area [BSA]) and randomized them 2:1 to DFD-01 or Vehicle. Products were applied twice daily to affected areas for 28 days. Treatment success was defined as an IGA=0 or 1 and ≥2-grade improvement from baseline. Primary endpoint was the proportion of subjects achieving treatment success at day 15.
RESULTS: Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; 87 Vehicle) and Study 2 (182 DFD-01; 95 Vehicle). Mean BSA was 13–14%. Treatment success was achieved in significantly more subjects using DFD-01 than Vehicle at day 15 in both Study 1 (P<0.001) and Study 2 (P=0.002), and at day 29 (both studies P<0.001). Treatment success with DFD-01 was significant at day 8 in Study 1 (P=0.003) but not in Study 2 (P=0.156). Erythema, scaling, and plaque elevation scores of target lesions were significantly reduced as early as day 4 with DFD-01. Adverse events were similar between groups, with no increase between 2 and 4 weeks.
CONCLUSION: These studies demonstrate DFD-01’s excellent efficacy and safety for the treatment of extensive psoriasis (10–20% BSA). DFD-01 achieved treatment success in significantly more subjects than Vehicle after 2 and 4 weeks of treatment, and showed early onset of action with improved signs of erythema, scaling and elevation of target lesions after 4 days of treatment. This medium potency formulation provides a safe and effective choice for topical steroid treatment of psoriasis.

J Drugs Dermatol. 2016;15(3):334-342.

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INTRODUCTION

Chronic plaque psoriasis is an inflammatory skin condition reported to affect approximately 2% of the United States adult population.1,2 Topical steroids are the cornerstone of treatment of psoriasis, and have been used to treat psoriatic skin since the 1930s.3,4 Recommended for the treatment of approximately 80% of psoriasis patients who have mild to moderate disease, topical steroids are also typically continued as adjunctive therapy in moderate to severe patients who are on biologic therapy.2

Today, there are many topical steroids available in various formulations. Characteristics that differ between products are the steroid itself, its concentration, as well as the vehicle ingredients and how these influence the delivery of the steroid to the site of disease.

One way topical steroids are classified is by their potency. This is usually listed in the FDA-approved product information as anything ranging from “super-high” to “low” potency. Steroid potency is currently measured by the vasoconstrictor assay (VCA), which depends on the extent to which the steroid diffuses into the dermal vasculature and the pharmacology of the steroid molecule.5 Once in the systemic circulation, steroids have the potential to suppress the hypothalamic–pituitary–adrenal (HPA) axis. For example, a super potent steroid will be more systemically available than a mid potent steroid and would therefore carry a greater risk of potential HPA axis suppression. Several topical steroids commonly used for psoriasis are only indicated for 2 weeks due to their potential for HPA axis suppression as well as for adverse events (AEs) in general, such as atrophy. To date, there has been fairly high concordance between VCA score and steroid efficacy (the more potent the steroid rates on the VCA, the more efficacious the steroid). A strong relationship has also been demonstrated between potency as measured by the VCA and local side effects of atrophy and telangiectasia.

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