Topical monotherapy with clobetasol propionate spray 0.05% in the COBRA trial

Abstract

The Clobex Spray Community-Based Research Assessment (COBRA) trial, a large, 4-week, open-label, observational trial, evaluated the use of twice-daily clobetasol propionate spray 0.05% in subjects with moderate to severe plaque psoriasis affecting 3% to 20% body surface area (BSA). The study was designed to augment existing phase 3 clinical trial data. In this trial, 1254 subjects in the effectiveness-evaluable (EE) population were treated with clobetasol propionate spray 0.05% as monotherapy. Clinical effectiveness was evaluated at weeks 2 and 4 using a 6-point target plaque severity (TPS) scale and 7-point investigators' global assessment of improvement (GAI) scale. Psoriasis TPS at week 0 (baseline) was rated as moderate to severe in more than 90% of subjects. After 2 weeks of clobetasol propionate spray 0.05% monotherapy, statistically significant improvement in TPS was seen at weeks 2 and 4 (P < .001). In addition, statistically significant improvement was seen at week 4 versus week 2 (P < .001) using the GAI scale. Clobetasol propionate spray 0.05% monotherapy was well-tolerated as assessed by erythema, peeling/scaling, dryness, stinging/burning, telangiectasia, skin atrophy, pruritus, and folliculitis. Skin and subcutaneous tissue disorders as well as general disorders and application-site conditions defined as possibly or probably related to therapy occurred in 1.0% and less than 1.0% of subjects, respectively. In addition, more than 90% of subjects were reported by investigators as being very satisfied or somewhat satisfied with their treatment at week 4. Based on these data, clobetasol propionate spray 0.05% is an effective and convenient topical monotherapy for moderate to severe plaque psoriasis.