Topical Miconazole Nitrate Ointment in the Treatment of Diaper Dermatitis Complicated by Candidiasis

Diaper dermatitis (DD) complicated by candidiasis is a common problem in diaper-wearing infants and children. We report a double-blind, vehicle-controlled, parallel-group study evaluating the efficacy and safety of a low concentration of miconazole nitrate in a zinc oxide/petrolatum ointment for the treatment of DD complicated by candidiasis. Patients (N=330) who had DD with a severity score of 3 or higher were enrolled. Those patients with a baseline potassium hydroxide (KOH) preparation and a baseline culture specimen that both tested positive for Candida were retained for efficacy analysis (n=236). Miconazole nitrate 0.25% ointment or a zinc oxide/petrolatum vehicle control were applied to all clinically affected areas of patients with DD for 7 days at each diaper change and after bathing. A follow-up test-of-cure visit was conducted at day 14. Among the patients completing the study, the overall rate of cure (clinical cure plus microbiologic cure) was 23% for the miconazole nitrate group and 10% for the vehicle control group (P=.005); the rate of clinical cure (complete rash clearance, DD severity score=0 at day 14) was 38% for the miconazole nitrate group and 11% for the vehicle control group (P