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Rationale of frequency of use of ciclopirox 1% shampoo in the treatment of seborrheic dermatitis: results of a double-blind, placebo-controlled study comparing the efficacy of once, twice, and three times weekly usage.
Int J Dermatol. 2004 Jul; 43 Suppl 1:13-6.IJ

Abstract

BACKGROUND

Seborrheic dermatitis is a common inflammatory skin disorder. Although the precise etiology of seborrheic dermatitis is uncertain, yeasts of the genus Malassezia have been implicated. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties.

METHODS

A total of 183 patients were enrolled in this randomized, parallel-group, double-blind, vehicle-controlled trial designed to compare three different application frequencies of ciclopirox 1% shampoo: once, twice, and three times weekly. 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 seborrheic dermatitis, and global change of seborrheic dermatitis.

RESULTS

Each application frequency of ciclopirox 1% shampoo was found to significantly improve the signs and symptoms of seborrheic dermatitis of the scalp after 4 weeks of treatment. Furthermore, the therapeutic index calculated from the global change in seborrheic dermatitis score increased with increasing application frequency; therapeutic index scores increased from vehicle (1.25) to ciclopirox 1% once (3.30), twice (3.50), and three times (3.56) weekly. No serious adverse events were recorded during the course of the study.

CONCLUSIONS

Ciclopirox 1% shampoo, applied once, twice or three times weekly, is a safe and acceptable preparation that improves seborrheic dermatitis of the scalp, suggesting that this is an alternative treatment for this indication.

Authors+Show Affiliations

Abeck D
Department of Dermatology and Allergy, Biederstein, Technical University Munich, Munich, Germany. dietrich.abeck@lrz.tu-muenchen.de
Loprox Shampoo Dosing Study Group
No affiliation info available

MeSH

Administration, CutaneousAdolescentAdultAgedAntifungal AgentsCiclopiroxDermatitis, SeborrheicDouble-Blind MethodDrug Administration ScheduleFemaleHair PreparationsHumansMaleMiddle AgedPyridonesScalp DermatosesTreatment Outcome

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15271195

Citation

Abeck, Dietrich, and Loprox Shampoo Dosing Study Group. "Rationale of Frequency of Use of Ciclopirox 1% Shampoo in the Treatment of Seborrheic Dermatitis: Results of a Double-blind, Placebo-controlled Study Comparing the Efficacy of Once, Twice, and Three Times Weekly Usage." International Journal of Dermatology, vol. 43 Suppl 1, 2004, pp. 13-6.
Abeck D, Loprox Shampoo Dosing Study Group. Rationale of frequency of use of ciclopirox 1% shampoo in the treatment of seborrheic dermatitis: results of a double-blind, placebo-controlled study comparing the efficacy of once, twice, and three times weekly usage. Int J Dermatol. 2004;43 Suppl 1:13-6.
Abeck, D. (2004). Rationale of frequency of use of ciclopirox 1% shampoo in the treatment of seborrheic dermatitis: results of a double-blind, placebo-controlled study comparing the efficacy of once, twice, and three times weekly usage. International Journal of Dermatology, 43 Suppl 1, 13-6.
Abeck D, Loprox Shampoo Dosing Study Group. Rationale of Frequency of Use of Ciclopirox 1% Shampoo in the Treatment of Seborrheic Dermatitis: Results of a Double-blind, Placebo-controlled Study Comparing the Efficacy of Once, Twice, and Three Times Weekly Usage. Int J Dermatol. 2004;43 Suppl 1:13-6. PubMed PMID: 15271195.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rationale of frequency of use of ciclopirox 1% shampoo in the treatment of seborrheic dermatitis: results of a double-blind, placebo-controlled study comparing the efficacy of once, twice, and three times weekly usage. AU - Abeck,Dietrich, AU - ,, PY - 2004/7/24/pubmed PY - 2005/2/3/medline PY - 2004/7/24/entrez SP - 13 EP - 6 JF - International journal of dermatology JO - Int J Dermatol VL - 43 Suppl 1 N2 - BACKGROUND: Seborrheic dermatitis is a common inflammatory skin disorder. Although the precise etiology of seborrheic dermatitis is uncertain, yeasts of the genus Malassezia have been implicated. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties. METHODS: A total of 183 patients were enrolled in this randomized, parallel-group, double-blind, vehicle-controlled trial designed to compare three different application frequencies of ciclopirox 1% shampoo: once, twice, and three times weekly. 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 seborrheic dermatitis, and global change of seborrheic dermatitis. RESULTS: Each application frequency of ciclopirox 1% shampoo was found to significantly improve the signs and symptoms of seborrheic dermatitis of the scalp after 4 weeks of treatment. Furthermore, the therapeutic index calculated from the global change in seborrheic dermatitis score increased with increasing application frequency; therapeutic index scores increased from vehicle (1.25) to ciclopirox 1% once (3.30), twice (3.50), and three times (3.56) weekly. No serious adverse events were recorded during the course of the study. CONCLUSIONS: Ciclopirox 1% shampoo, applied once, twice or three times weekly, is a safe and acceptable preparation that improves seborrheic dermatitis of the scalp, suggesting that this is an alternative treatment for this indication. SN - 0011-9059 UR - https://www.unboundmedicine.com/medline/citation/15271195/Rationale_of_frequency_of_use_of_ciclopirox_1_shampoo_in_the_treatment_of_seborrheic_dermatitis:_results_of_a_double_blind_placebo_controlled_study_comparing_the_efficacy_of_once_twice_and_three_times_weekly_usage_ DB - PRIME DP - Unbound Medicine ER -