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Sam Shuster, MD; Jean Meynadier, MD; Helmut Kerl, MD; Siegfried Nolting, MD

Arch Dermatol. 2005;141:47-52.

Objective  To demonstrate the efficacy, safety, and tolerance of ciclopirox shampoo for treatment and prophylaxis of seborrheic dermatitis of the scalp.

Design  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).

Setting  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.

Main Outcome Measures  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.

Author Affiliations: Departments of Dermatology, University Hospital, Norwich, England (Dr Shuster) and Saint-Eloi Hospital, Montpellier, France (Dr Meynadier); Department of Dermatology and Venereology, Graz University Hospital, Graz, Austria (Dr Kerl); and Department of Dermatology, University of Muenster, Muenster, Germany (Dr Nolting).

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