Treatment and prophylaxis of seborrheic dermatitis of the scalp with antipityrosporal 1% ciclopirox shampoo.
OBJECTIVE
To demonstrate the efficacy, safety, and tolerance of ciclopirox shampoo for treatment and prophylaxis of seborrheic dermatitis of the scalp.


METHODS
Multicenter, randomized, double-blind, vehicle-controlled study. After treatment with ciclopirox shampoo once or twice weekly or vehicle for 4 weeks (study segment A), responders were randomized to a 12-week prophylactic study arm (segment B).


METHODS
Forty-five medical centers in Germany (n = 19), France (n = 15), the United Kingdom (n = 8), and Austria (n = 3). Patients A total of 1000 patients with stable or exacerbating seborrheic dermatitis of the scalp. Interventions A total of 949 patients were randomized to receive ciclopirox treatment once or twice weekly or vehicle for 4 weeks. Thereafter, 428 responders received either ciclopirox prophylaxis once weekly or every 2 weeks or vehicle for 3 months.


METHODS
Primary and secondary: response of "effectively treated" and "cured," with investigators and patients rating acceptability and tolerance.


RESULTS
Ciclopirox twice and once weekly produced response rates of 57.9% and 45.4%, respectively, compared with 31.6% for vehicle. Relapses occurred in 14.7% of patients using prophylactic ciclopirox once weekly, 22.1% of those in the prophylactic group shampooing once every 2 weeks, and 35.5% in the vehicle group. The few adverse events were evenly distributed among groups. Local tolerance and cosmetic acceptability were "good" in more than 85% of subjects.


CONCLUSIONS
Seborrheic dermatitis of the scalp responds well to 1% ciclopirox shampoo once or twice weekly for 4 weeks. A low relapse rate is maintained by once-weekly shampooing or shampooing once every 2 weeks. These treatments are safe and well-tolerated.
Shuster
Sam
S
Department of Dermatology, University Hospital, Norwich, England. sam@shuster42.freeserve.co.uk
Meynadier
Jean
J
Kerl
Helmut
H
Nolting
Siegfried
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077768:Ciclopirox; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004954:Esthetics; D005260:Female; D006203:Hair Preparations; D006801:Humans; D008290:Malassezia / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011728:Pyridones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000382:microbiology / Q000517:prevention & control*
D000935:Antifungal Agents; D006203:Hair Preparations; D011728:Pyridones; D000077768:Ciclopirox