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Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial.
Int J Dermatol. 2004 Jul; 43 Suppl 1:17-20.IJ

Abstract

BACKGROUND

Seborrheic dermatitis is a common inflammatory skin disorder. Yeasts of the genus Malassezia have been implicated in the etiology of seborrheic dermatitis, although this connection remains controversial. Ciclopirox is a synthetic, hydroxypyridone-derived, broad-spectrum antifungal agent with anti-inflammatory properties.

METHODS

A total of 499 US patients with seborrheic dermatitis of the scalp were randomized to apply either ciclopirox shampoo 1% or vehicle twice weekly for 4 weeks. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, erythema and itching) and a 6-point scale providing a global evaluation of the status of seborrheic dermatitis.

RESULTS

Ciclopirox was significantly better than vehicle in effectively treating seborrheic dermatitis. 'Effective treatment' (score of 0 or 1 for disease status, scaling and erythema) was achieved in 26.0% of ciclopirox-treated patients compared with 12.9% of vehicle-treated patients (P = 0.0001; OR: 2.383, 95% CI: 1.494-3.799). The majority of subjects experienced adverse events that were mild in intensity, with skin and appendage reactions the most commonly reported, at similar frequency in both groups.

CONCLUSIONS

Ciclopirox shampoo 1% is effective and safe in the treatment of seborrheic dermatitis of the scalp.

Authors+Show Affiliations

Lebwohl M
Mount Sinai School of Medicine, New York, NY, USA.
Plott T
No affiliation info available

MeSH

Administration, CutaneousAntifungal AgentsCiclopiroxDermatitis, SeborrheicDouble-Blind MethodFemaleHair PreparationsHumansMalePyridonesScalp DermatosesTreatment OutcomeUnited States

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15271196

Citation

Lebwohl, Mark, and Todd Plott. "Safety and Efficacy of Ciclopirox 1% Shampoo for the Treatment of Seborrheic Dermatitis of the Scalp in the US Population: Results of a Double-blind, Vehicle-controlled Trial." International Journal of Dermatology, vol. 43 Suppl 1, 2004, pp. 17-20.
Lebwohl M, Plott T. Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial. Int J Dermatol. 2004;43 Suppl 1:17-20.
Lebwohl, M., & Plott, T. (2004). Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial. International Journal of Dermatology, 43 Suppl 1, 17-20.
Lebwohl M, Plott T. Safety and Efficacy of Ciclopirox 1% Shampoo for the Treatment of Seborrheic Dermatitis of the Scalp in the US Population: Results of a Double-blind, Vehicle-controlled Trial. Int J Dermatol. 2004;43 Suppl 1:17-20. PubMed PMID: 15271196.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of ciclopirox 1% shampoo for the treatment of seborrheic dermatitis of the scalp in the US population: results of a double-blind, vehicle-controlled trial. AU - Lebwohl,Mark, AU - Plott,Todd, PY - 2004/7/24/pubmed PY - 2005/2/3/medline PY - 2004/7/24/entrez SP - 17 EP - 20 JF - International journal of dermatology JO - Int J Dermatol VL - 43 Suppl 1 N2 - BACKGROUND: Seborrheic dermatitis is a common inflammatory skin disorder. Yeasts of the genus Malassezia have been implicated in the etiology of seborrheic dermatitis, although this connection remains controversial. Ciclopirox is a synthetic, hydroxypyridone-derived, broad-spectrum antifungal agent with anti-inflammatory properties. METHODS: A total of 499 US patients with seborrheic dermatitis of the scalp were randomized to apply either ciclopirox shampoo 1% or vehicle twice weekly for 4 weeks. The main efficacy parameters were based on 6-point ordinal scales describing the disease's signs and symptoms (scaling, erythema and itching) and a 6-point scale providing a global evaluation of the status of seborrheic dermatitis. RESULTS: Ciclopirox was significantly better than vehicle in effectively treating seborrheic dermatitis. 'Effective treatment' (score of 0 or 1 for disease status, scaling and erythema) was achieved in 26.0% of ciclopirox-treated patients compared with 12.9% of vehicle-treated patients (P = 0.0001; OR: 2.383, 95% CI: 1.494-3.799). The majority of subjects experienced adverse events that were mild in intensity, with skin and appendage reactions the most commonly reported, at similar frequency in both groups. CONCLUSIONS: Ciclopirox shampoo 1% is effective and safe in the treatment of seborrheic dermatitis of the scalp. SN - 0011-9059 UR - https://www.unboundmedicine.com/medline/citation/15271196/Safety_and_efficacy_of_ciclopirox_1_shampoo_for_the_treatment_of_seborrheic_dermatitis_of_the_scalp_in_the_US_population:_results_of_a_double_blind_vehicle_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -