Ciclopiroxolamine Cream 1% in the Treatment of Seborrhoeic Dermatitis A Double-Blind, Parallel-Group Comparison with Ketoconazole and Vehicle in a Confirmatory Trial

摘要

Objective: To compare the efficacy and tolerability of topically applied ciclopiroxolamine cream with that of ketoconazole cream and the corresponding vehicle in patients with seborrhoeic dermatitis.Design and setting: The study was conducted as a multicentre, prospective, randomised, double-blind, parallel-group comparison at five centres in Germany.Patients: 165 patients with clinically diagnosed seborrhoeic dermatitis participated in the study.Interventions: Each patient applied ciclopiroxolamine 1% cream, ketoconazole 2% cream or the vehicle of the former cream once daily as a thin film to the affected skin areas for 28 days. In case of complete resolution, treatment was terminated prematurely.Results: Clinical response rates were significantly higher with ciclopiroxolamine than with vehicle (in the intention-to-treat population: 81.8% vs 59.6%, p = 0.013; in the per-protocol population: 78.7% vs 57.7%, p = 0.032). The response rate in the ketoconazole group was 73.6% with regard to the intention-to-treat population and 57.7% with regard to the per-protocol population. Treatment with ciclopiroxolamine reduced the sum score of the clinical signs of seborrhoeic dermatitis to a greater extent than did vehicle (p = 0.0001). Differences between the treatment groups with regard to recurrence rates were not statistically significant. Ciclopiroxolamine was well tolerated; adverse events assumed to be treatment-related were detected clinically in only one of 55 patients (1.8%).Conclusions: This study demonstrates for the first time, using confirmatory data analysis, that topical treatment with ciclopiroxolamine is effective and well tolerated in patients with seborrhoeic dermatitis.