Evaluation of the Efficacy and Safety of Clobetasol Propionate Spray in the Treatment of Plaque-Type Psoriasis
Jarratt MT, Clark SD, Savin RC, Swinyer LJ, Safley CF, Brodell RT, Yu K
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