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Treatment and prophylaxis of seborrheic dermatitis of the scalp with antipityrosporal 1% ciclopirox shampoo.
Arch Dermatol. 2005 Jan; 141(1):47-52.AD

Abstract

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.

Authors+Show Affiliations

Shuster S
Department of Dermatology, University Hospital, Norwich, England. sam@shuster42.freeserve.co.uk
Meynadier J
No affiliation info available
Kerl H
No affiliation info available
Nolting S
No affiliation info available

MeSH

AdultAgedAged, 80 and overAntifungal AgentsCiclopiroxDermatitis, SeborrheicDouble-Blind MethodDrug Administration ScheduleEstheticsFemaleHair PreparationsHumansMalasseziaMaleMiddle AgedPatient SatisfactionPyridonesScalp Dermatoses

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15655141

Citation

Shuster, Sam, et al. "Treatment and Prophylaxis of Seborrheic Dermatitis of the Scalp With Antipityrosporal 1% Ciclopirox Shampoo." Archives of Dermatology, vol. 141, no. 1, 2005, pp. 47-52.
Shuster S, Meynadier J, Kerl H, et al. Treatment and prophylaxis of seborrheic dermatitis of the scalp with antipityrosporal 1% ciclopirox shampoo. Arch Dermatol. 2005;141(1):47-52.
Shuster, S., Meynadier, J., Kerl, H., & Nolting, S. (2005). Treatment and prophylaxis of seborrheic dermatitis of the scalp with antipityrosporal 1% ciclopirox shampoo. Archives of Dermatology, 141(1), 47-52.
Shuster S, et al. Treatment and Prophylaxis of Seborrheic Dermatitis of the Scalp With Antipityrosporal 1% Ciclopirox Shampoo. Arch Dermatol. 2005;141(1):47-52. PubMed PMID: 15655141.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment and prophylaxis of seborrheic dermatitis of the scalp with antipityrosporal 1% ciclopirox shampoo. AU - Shuster,Sam, AU - Meynadier,Jean, AU - Kerl,Helmut, AU - Nolting,Siegfried, PY - 2005/1/19/pubmed PY - 2005/2/16/medline PY - 2005/1/19/entrez SP - 47 EP - 52 JF - Archives of dermatology JO - Arch Dermatol VL - 141 IS - 1 N2 - 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. SN - 0003-987X UR - https://www.unboundmedicine.com/medline/citation/15655141/Treatment_and_prophylaxis_of_seborrheic_dermatitis_of_the_scalp_with_antipityrosporal_1_ciclopirox_shampoo_ DB - PRIME DP - Unbound Medicine ER -