Rationale of frequency of use of ciclopirox 1% shampoo in the treatment of seborrheic dermatitis: results of a double-blind, placebo-controlled study comparing the efficacy of once, twice, and three times weekly usage.

Author(s): Abeck D, Loprox Shampoo Dosing Study Group

Affiliation(s): Department of Dermatology and Allergy, Biederstein, Technical University Munich, Munich, Germany. dietrich.abeck@lrz.tu-muenchen.de

Publication date & source: 2004-07, Int J Dermatol., 43 Suppl 1:13-6.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND: Seborrheic dermatitis is a common inflammatory skin disorder. Although the precise etiology of seborrheic dermatitis is uncertain, yeasts of the genus Malassezia have been implicated. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties. METHODS: A total of 183 patients were enrolled in this randomized, parallel-group, double-blind, vehicle-controlled trial designed to compare three different application frequencies of ciclopirox 1% shampoo: once, twice, and three times weekly. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, inflammation and itching), global status of seborrheic dermatitis, and global change of seborrheic dermatitis. RESULTS: Each application frequency of ciclopirox 1% shampoo was found to significantly improve the signs and symptoms of seborrheic dermatitis of the scalp after 4 weeks of treatment. Furthermore, the therapeutic index calculated from the global change in seborrheic dermatitis score increased with increasing application frequency; therapeutic index scores increased from vehicle (1.25) to ciclopirox 1% once (3.30), twice (3.50), and three times (3.56) weekly. No serious adverse events were recorded during the course of the study. CONCLUSIONS: Ciclopirox 1% shampoo, applied once, twice or three times weekly, is a safe and acceptable preparation that improves seborrheic dermatitis of the scalp, suggesting that this is an alternative treatment for this indication.