An Intra-Individual Randomized Safety and Efficacy Comparison of Clobetasol Propionate 0.05% Spray and its Vehicle in the Treatment of Plaque Psoriasis
April 2006 | Volume 5 | Issue 4 | Original Article | 357 | Copyright © April 2006
Karl Beutner MD PhD, Arun Chakrabarty MD, Shawna Lemke PhD, Karen Yu PhD
AbstractBackground: Plaque psoriasis affects about 2% of the US population. A new and unique spray formulation of clobetasol propionate (CP) 0.05% was developed to provide advantages over the currently available treatment formulations.
Objectives: To evaluate the efficacy and safety of CP 0.05% spray compared to its vehicle in the treatment of moderate to severe plaque psoriasis.
Methods: A 4-week, single-center, randomized, double-blind, vehicle-controlled, intra-individual study in subjects with plaque psoriasis. Each of 2 target lesions per subject were randomized to receive either CP 0.05% spray or its vehicle twice daily over 4 weeks. Efficacy parameters included overall target plaque severity score, scaling, erythema, and plaque elevation at all visits. Adverse events were reported throughout the study.
Results: A total of 27 subjects were enrolled in the study. At all visits there was a significant intra-individual treatment effect for the overall target plaque severity (P<.001) in favor of CP spray. Throughout the study, results for scaling, erythema, and plaque elevation were significantly (P<.001) in favor of CP spray. After 4 weeks of treatment, all intra-individual response measures, with the exception of erythema, showed an average difference in severity scores of more than 4 points (based on a 9-point scale) between the lesions treated with CP 0.05% spray and the lesions treated with vehicle. No serious adverse event occurred during the course of the study. One local adverse event at the application site (5%) was considered probably related to study medication.
Conclusion: CP 0.05% spray was effective and safe in reducing overall plaque severity, scaling, erythema, and plaque elevation from the first week of treatment continuing throughout the trial.