Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial.
BACKGROUND
Seborrheic dermatitis is a common inflammatory skin disorder. Yeasts of the genus Malassezia have been implicated in the etiology of seborrheic dermatitis, although this connection remains controversial. Ciclopirox is a synthetic, hydroxypyridone-derived, broad-spectrum antifungal agent with anti-inflammatory properties.


METHODS
A total of 499 US patients with seborrheic dermatitis of the scalp were randomized to apply either ciclopirox shampoo 1% or vehicle twice weekly for 4 weeks. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, erythema and itching) and a 6-point scale providing a global evaluation of the status of seborrheic dermatitis.


RESULTS
Ciclopirox was significantly better than vehicle in effectively treating seborrheic dermatitis. 'Effective treatment' (score of 0 or 1 for disease status, scaling and erythema) was achieved in 26.0% of ciclopirox-treated patients compared with 12.9% of vehicle-treated patients (P = 0.0001; OR: 2.383, 95% CI: 1.494-3.799). The majority of subjects experienced adverse events that were mild in intensity, with skin and appendage reactions the most commonly reported, at similar frequency in both groups.


CONCLUSIONS
Ciclopirox shampoo 1% is effective and safe in the treatment of seborrheic dermatitis of the scalp.
Lebwohl
Mark
M
Mount Sinai School of Medicine, New York, NY, USA.
Plott
Todd
T
D000279:Administration, Cutaneous; D000935:Antifungal Agents / Q000008:administration & dosage*; D000077768:Ciclopirox; D012628:Dermatitis, Seborrheic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006203:Hair Preparations; D006801:Humans; D008297:Male; D011728:Pyridones / Q000008:administration & dosage*; D012536:Scalp Dermatoses / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States
D000935:Antifungal Agents; D006203:Hair Preparations; D011728:Pyridones; D000077768:Ciclopirox