Efficacy of different concentrations of ciclopirox shampoo for the treatment of seborrheic dermatitis of the scalp: results of a randomized, double-blind, vehicle-controlled trial.
BACKGROUND
Seborrheic dermatitis is a common inflammatory skin disorder affecting 1-3% of the population. It is thought to be linked to dandruff via a common etiology, yeasts of the genus Malassezia. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties.


METHODS
A total of 203 patients were enrolled in this vehicle-controlled, double-blind, randomized study designed to compare vehicle with three different concentrations of ciclopirox shampoo: 0.1%, 0.3% and 1%, with each applied twice a week. 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 disease, and global change in disease.


RESULTS
A tendency towards improvement of the sum score from baseline was found in all ciclopirox treatment groups. The most pronounced improvement was found in the ciclopirox 1% group, which changed from a baseline sum score of 8.3 to 4.4 at the end of the 4-week study period (P-value vs. vehicle 0.0372). In addition, the therapeutic index showed increasing efficacy with the use of increased concentrations of ciclopirox.


CONCLUSIONS
The study supports the use of 1% ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp. Furthermore, ciclopirox shampoo at each concentration was found to be safe and well tolerated.
Altmeyer
Peter
P
Department of Dermatology, Ruhr-University Bochum, St. Josef-Hospital, Bochum, Germany. p.altmeyer@derma.de
Hoffmann
Klaus
K
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D000077768:Ciclopirox; D012628:Dermatitis, Seborrheic / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; 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