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.
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.
Department of Dermatology and Allergy, Biederstein, Technical University Munich, Munich, Germany. dietrich.abeck@lrz.tu-muenchen.de
Dietrich
D
Abeck
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D000077768:Ciclopirox; D012628:Dermatitis, Seborrheic / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006203:Hair Preparations; D006801:Humans; D008297:Male; D008875:Middle Aged; D011728:Pyridones / Q000008:administration & dosage*; D012536:Scalp Dermatoses / Q000188:drug therapy*; D016896:Treatment Outcome
D000935:Antifungal Agents; D006203:Hair Preparations; D011728:Pyridones; D000077768:Ciclopirox