title: Evaluation of the efficacy and safety of clobetasol propionate spray in the treatment of plaque-type psoriasis.
abstract: Treatment of the inflammatory component of plaque psoriasis is an important part of psoriasis management. A new and unique spray formulation of clobetasol propionate 0.05% may provide advantages over the currently available formulations through easy application to hard-to-reach areas and the ability to deliver a fixed dose of corticosteroid per spray. The purpose of this study was to evaluate the efficacy and safety of clobetasol propionate spray 0.05% in the treatment of moderate to severe plaque-type psoriasis. This study was conducted as a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group, comparative study in subjects with plaque psoriasis. Subjects were randomized to receive either clobetasol propionate spray 0.05% (n=60) or vehicle spray (n=60) twice daily for 4 weeks, followed by a 4-week treatment-free follow-up period. Efficacy evaluations at all visits included assessment of scaling, erythema, plaque elevation, pruritus, and overall disease severity. Success rates for each of the signs and symptoms evaluated, as well as for the overall disease severity assessment, were significantly in favor of clobetasol propionate (P<.001). The additional 2 weeks of treatment from weeks 2 to 4 increased the number of cleared subjects from 2% to 25%; treatment success was still in favor of clobetasol propionate (P<.001) at week 8 (4 weeks post-treatment). No treatment-related serious adverse events occurred during the course of the study. Mild application site burning/stinging was the most common treatment-related adverse event, with similar frequency and severity for both active and vehicle groups. There were no reports of skin atrophy, telangiectasia, folliculitis, or hypothalamus-pituitary-adrenal axis suppression. Overall, clobetasol propionate spray 0.05% administered twice daily for 4 weeks was effective and safe in reducing scaling, erythema, plaque elevation, and overall disease severity and demonstrates durable clinical response up to 4 weeks after treatment end.
authors.affiliation: DermResearch, Inc, Austin, Texas, USA.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Jarratt
authors.forename: Scott D
authors.initials: SD
authors.lastname: Clark
authors.forename: Ronald C
authors.initials: RC
authors.lastname: Savin
authors.forename: Leonard J
authors.initials: LJ
authors.lastname: Swinyer
authors.forename: Charles F
authors.initials: CF
authors.lastname: Safley
authors.forename: Robert T
authors.initials: RT
authors.lastname: Brodell
authors.forename: Karen
authors.initials: K
authors.lastname: Yu
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002990:Clobetasol / Q000008:administration & dosage* / Q000009:adverse effects; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; D002990:Clobetasol