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A multicenter, open-label study to assess the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans.
J Drugs Dermatol. 2005 Jan-Feb; 4(1):29-34.JD

Abstract

Ciclopirox is a broad-spectrum antifungal, antibacterial, and anti-inflammatory agent. This open-label study investigated the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans (C. albicans). Forty-four male and female subjects aged 6 to 29 months were included in the study. Study medication was applied topically to the affected diaper area twice daily for 1 week. Subjects were clinically evaluated at baseline and days 3, 7, and 14 (7 days post-treatment). Safety and efficacy variables included adverse events, mycological culture studies, KOH tests, Severity Scores, and Global Evaluation of Clinical Response. All adverse events were mild to moderate and considered not related to the study medication. Treatment provided statistically significant improvement (P < .05) for both the rate of mycological cure and reduction of Severity Score at each time point compared with baseline. Ciclopirox was safe and effective in the treatment of diaper dermatitis due to C. albicans.

Authors+Show Affiliations

Medical Strategies Inc., Mission, KS 66202, USA. bethg@nchqa.orgNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

15696982

Citation

Gallup, Elizabeth, et al. "A Multicenter, Open-label Study to Assess the Safety and Efficacy of Ciclopirox Topical Suspension 0.77% in the Treatment of Diaper Dermatitis Due to Candida Albicans." Journal of Drugs in Dermatology : JDD, vol. 4, no. 1, 2005, pp. 29-34.
Gallup E, Plott T, Ciclopirox TS Investigators. A multicenter, open-label study to assess the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans. J Drugs Dermatol. 2005;4(1):29-34.
Gallup, E., & Plott, T. (2005). A multicenter, open-label study to assess the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans. Journal of Drugs in Dermatology : JDD, 4(1), 29-34.
Gallup E, Plott T, Ciclopirox TS Investigators. A Multicenter, Open-label Study to Assess the Safety and Efficacy of Ciclopirox Topical Suspension 0.77% in the Treatment of Diaper Dermatitis Due to Candida Albicans. J Drugs Dermatol. 2005 Jan-Feb;4(1):29-34. PubMed PMID: 15696982.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, open-label study to assess the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans. AU - Gallup,Elizabeth, AU - Plott,Todd, AU - ,, PY - 2005/2/9/pubmed PY - 2005/4/30/medline PY - 2005/2/9/entrez SP - 29 EP - 34 JF - Journal of drugs in dermatology : JDD JO - J Drugs Dermatol VL - 4 IS - 1 N2 - Ciclopirox is a broad-spectrum antifungal, antibacterial, and anti-inflammatory agent. This open-label study investigated the safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans (C. albicans). Forty-four male and female subjects aged 6 to 29 months were included in the study. Study medication was applied topically to the affected diaper area twice daily for 1 week. Subjects were clinically evaluated at baseline and days 3, 7, and 14 (7 days post-treatment). Safety and efficacy variables included adverse events, mycological culture studies, KOH tests, Severity Scores, and Global Evaluation of Clinical Response. All adverse events were mild to moderate and considered not related to the study medication. Treatment provided statistically significant improvement (P < .05) for both the rate of mycological cure and reduction of Severity Score at each time point compared with baseline. Ciclopirox was safe and effective in the treatment of diaper dermatitis due to C. albicans. SN - 1545-9616 UR - https://www.unboundmedicine.com/medline/citation/15696982/A_multicenter_open_label_study_to_assess_the_safety_and_efficacy_of_ciclopirox_topical_suspension_0_77_in_the_treatment_of_diaper_dermatitis_due_to_Candida_albicans_ DB - PRIME DP - Unbound Medicine ER -