Clobetasol Propionate 0.05% Spray for the Management of Moderate-to-Severe Plaque Psoriasis of the Scalp: Results From a Randomized Controlled Trial
August 2011 | Volume 10 | Issue 8 | Original Article | 885 | Copyright © August 2011
Howard Sofen MD,a Charles P. Hudson MD FAAD,b Fran E. Cook-Bolden MD,c Norman Preston PhD,d Luz E. Colón MS, CCRC, CCRAd, Scott W. Caveney MD PhD,d Ronald W. Gottschalk MD FRCPCd
aDermatology Research Associates, Los Angeles, CA; bHudson Dermatology, Evansville, IN; cResearch Division of The Skin Specialty Group, New York, NY; dGalderma Laboratories, L.P., Fort Worth, TX
Abstract
Background: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp.
Objective: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp.
Methods: Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events.
Results: At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P < .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome.
Conclusion: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.
J Drugs Dermatol. 2011;10(8):888-895.
INTRODUCTION
Recent estimates suggest that psoriasis affects between two and 3.5 percent of adults in the United States (U.S.), which corresponds to approximately 4.5 million to 8 million adults.1,2 Scalp involvement is commonly associated with plaque psoriasis, and is reported to occur in as many as 50 to 79 percent of patients3,4 and is more likely to occur with a longer duration of psoriasis.5 Scaling and pruritus are the most commonly identified symptoms, and lesions affecting the scalp can extend to a few centimeters beyond the hairline. Considerable social and psychological consequences, and an overall negative impact on quality of life, have been reported with plaque psoriasis of the scalp.3,6
The treatment of plaque psoriasis of the scalp is similar to that for lesions at other body sites. Topical corticosteroids are considered the mainstay treatment option across the spectrum of disease (extent of scalp area involved and severity).7 Clinicians can consider many different topical corticosteroids and vehicle/formulation options when selecting therapy for an individual patient with plaque psoriasis of the scalp, and it has been
