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.
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.
Gallup
Elizabeth
E
Medical Strategies Inc., Mission, KS 66202, USA. bethg@nchqa.org
Plott
Todd
T
D000287:Administration, Topical; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002179:Candidiasis, Cutaneous / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D002675:Child, Preschool; D000077768:Ciclopirox; D003872:Dermatitis / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D003963:Diaper Rash / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011728:Pyridones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013535:Suspensions; D016896:Treatment Outcome
D000935:Antifungal Agents; D011728:Pyridones; D013535:Suspensions; D000077768:Ciclopirox