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Efficacy of different concentrations of ciclopirox shampoo for the treatment of seborrheic dermatitis of the scalp: results of a randomized, double-blind, vehicle-controlled trial.
Int J Dermatol. 2004 Jul; 43 Suppl 1:9-12.IJ

Abstract

BACKGROUND

Seborrheic dermatitis is a common inflammatory skin disorder affecting 1-3% of the population. It is thought to be linked to dandruff via a common etiology, yeasts of the genus Malassezia. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties.

METHODS

A total of 203 patients were enrolled in this vehicle-controlled, double-blind, randomized study designed to compare vehicle with three different concentrations of ciclopirox shampoo: 0.1%, 0.3% and 1%, with each applied twice a week. 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 disease, and global change in disease.

RESULTS

A tendency towards improvement of the sum score from baseline was found in all ciclopirox treatment groups. The most pronounced improvement was found in the ciclopirox 1% group, which changed from a baseline sum score of 8.3 to 4.4 at the end of the 4-week study period (P-value vs. vehicle 0.0372). In addition, the therapeutic index showed increasing efficacy with the use of increased concentrations of ciclopirox.

CONCLUSIONS

The study supports the use of 1% ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp. Furthermore, ciclopirox shampoo at each concentration was found to be safe and well tolerated.

Authors+Show Affiliations

Altmeyer P
Department of Dermatology, Ruhr-University Bochum, St. Josef-Hospital, Bochum, Germany. p.altmeyer@derma.de
Hoffmann K
No affiliation info available
Loprox Shampoo Dosing Concentration Study Group
No affiliation info available

MeSH

Administration, CutaneousAdolescentAdultAgedAntifungal AgentsCiclopiroxDermatitis, SeborrheicDose-Response Relationship, DrugDouble-Blind MethodFemaleHair PreparationsHumansMaleMiddle AgedPyridonesScalp DermatosesTreatment Outcome

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15271194

Citation

Altmeyer, Peter, et al. "Efficacy of Different Concentrations of Ciclopirox Shampoo for the Treatment of Seborrheic Dermatitis of the Scalp: Results of a Randomized, Double-blind, Vehicle-controlled Trial." International Journal of Dermatology, vol. 43 Suppl 1, 2004, pp. 9-12.
Altmeyer P, Hoffmann K, Loprox Shampoo Dosing Concentration Study Group. Efficacy of different concentrations of ciclopirox shampoo for the treatment of seborrheic dermatitis of the scalp: results of a randomized, double-blind, vehicle-controlled trial. Int J Dermatol. 2004;43 Suppl 1:9-12.
Altmeyer, P., & Hoffmann, K. (2004). Efficacy of different concentrations of ciclopirox shampoo for the treatment of seborrheic dermatitis of the scalp: results of a randomized, double-blind, vehicle-controlled trial. International Journal of Dermatology, 43 Suppl 1, 9-12.
Altmeyer P, Hoffmann K, Loprox Shampoo Dosing Concentration Study Group. Efficacy of Different Concentrations of Ciclopirox Shampoo for the Treatment of Seborrheic Dermatitis of the Scalp: Results of a Randomized, Double-blind, Vehicle-controlled Trial. Int J Dermatol. 2004;43 Suppl 1:9-12. PubMed PMID: 15271194.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of different concentrations of ciclopirox shampoo for the treatment of seborrheic dermatitis of the scalp: results of a randomized, double-blind, vehicle-controlled trial. AU - Altmeyer,Peter, AU - Hoffmann,Klaus, AU - ,, PY - 2004/7/24/pubmed PY - 2005/2/3/medline PY - 2004/7/24/entrez SP - 9 EP - 12 JF - International journal of dermatology JO - Int J Dermatol VL - 43 Suppl 1 N2 - BACKGROUND: Seborrheic dermatitis is a common inflammatory skin disorder affecting 1-3% of the population. It is thought to be linked to dandruff via a common etiology, yeasts of the genus Malassezia. Ciclopirox is a broad-spectrum, hydroxypyridone-derived, synthetic antifungal agent with anti-inflammatory properties. METHODS: A total of 203 patients were enrolled in this vehicle-controlled, double-blind, randomized study designed to compare vehicle with three different concentrations of ciclopirox shampoo: 0.1%, 0.3% and 1%, with each applied twice a week. 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 disease, and global change in disease. RESULTS: A tendency towards improvement of the sum score from baseline was found in all ciclopirox treatment groups. The most pronounced improvement was found in the ciclopirox 1% group, which changed from a baseline sum score of 8.3 to 4.4 at the end of the 4-week study period (P-value vs. vehicle 0.0372). In addition, the therapeutic index showed increasing efficacy with the use of increased concentrations of ciclopirox. CONCLUSIONS: The study supports the use of 1% ciclopirox shampoo in the treatment of seborrheic dermatitis of the scalp. Furthermore, ciclopirox shampoo at each concentration was found to be safe and well tolerated. SN - 0011-9059 UR - https://www.unboundmedicine.com/medline/citation/15271194/Efficacy_of_different_concentrations_of_ciclopirox_shampoo_for_the_treatment_of_seborrheic_dermatitis_of_the_scalp:_results_of_a_randomized_double_blind_vehicle_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -