Clinical Study Results of Desoximetasone Spray, 0.25% in Moderate to Severe Plaque Psoriasis
December 2013 | Volume 12 | Issue 12 | Original Article | 1404 | Copyright © December 2013
Leon Kircik MD,a,b,c Mark G. Lebwohl MD,c James Q. Del Rosso DO,d
Jerry Bagel MD,eLinda Stein Gold MD,f Jonathan S. Weiss MDg
aDepartment of Dermatology, Indiana University School of Medicine, Indianapolis, IN
bPhysicians Skin Care, PLLC, Louisville, KY
cDepartment of Dermatology, Mount Sinai School of Medicine, New York, New York
dDepartment of Dermatology, Touro University College of Osteopathic Medicine, Henderson, NV
ePsoriasis Treatment Center of Central New Jersey, East Windsor, NJ
fDirector of Dermatology, Clinical Research and Division Head of Dermatology, Henry Ford Health System, Detroit and West Bloomfield, Michigan
gGwinnett Clinical Research Center, Snellville, Georgia
Abstract
Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of desoximetasone spray 0.25%, a super-potent topical corticosteroid, twice daily vs vehicle spray twice daily for 28 days in adult patients with moderate to severe plaque psoriasis. At baseline and throughout the study, the severity of disease for the psoriatic lesions was assessed using the Physician Global Assessment (PGA) score and a target lesion was assessed using the Total Lesion Severity Score (TLSS). A designated psoriatic plaque lesion was selected as the target lesion upon enrollment and evaluated throughout the study to determine the TLSS. To qualify for study entry, the subject needed to exhibit a PGA score of 3 (moderate) or 4 (severe) for overall disease severity, and a target lesion with an area of at least 5 cm2 that achieved a combined score TLSS of >=7, with a plaque elevation score of >=3 (at least moderate). The mean % BSA affected by psoriasis ranged from 13%-17% at baseline.
In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily.
Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.
J Drugs Dermatol. 2013;12(12):1404-1410.
INTRODUCTION
The anti-inflammatory properties of a topically-applied
corticosteroid (CS) have been well recognized since the
discovery of Compound F (hydrocortisone) in 1949.1 In
1958, dexamethasone was introduced after a search for a more
metabolically stable compound with greater anti-inflammatory
activity and decreased mineralocorticoid effect when given
systemically. Attempts to find additional corticosteroid
compounds resulted in the discovery and development of
desoximetasone (16α-methyl-9 α-fluoro-Δ,-corticosterone),
a derivative of dexamethasone. Animal studies confirmed
the anti-inflammatory activity of desoximetasone, with the
determination that the pharmacologic properties of this agent
were most amenable to topical administration.
Topically applied desoximetasone was first used in Brazil in 1973.
The first topical formulation of desoximetasone (0.25% cream)
was approved in the United States (US) by the Food and Drug
Administration (FDA) in 1977.1 The indication was for relief of
the inflammatory and pruritic manifestations of corticosteroidresponsive
dermatoses, based on studies conducted in subjects
