Diaper dermatitis: a therapeutic dilemma. Results of a double-blind placebo controlled trial of miconazole nitrate 0.25%.
Diaper dermatitis, an acute inflammation of the skin in the diaper area, is the most common dermatologic disorder of infancy. This placebo-controlled, randomized, double-blind, parallel-group trial compared the efficacy and safety of miconazole nitrate 0.25% in a zinc oxide/petrolatum base with that of the ointment base alone in treating acute diaper dermatitis in infants and evaluated the role of Candida albicans in the response to treatment. Infants age 2-13 months with diaper rash were treated with either miconazole nitrate 0.25% (N = 101) or ointment base (N = 101) for 7 days. Although improvement in rash from baseline was seen in both treatment groups on days 3, 5, and 7, patients receiving miconazole nitrate 0.25% had significantly fewer rash sites and lower mean total rash scores on days 5 and 7 (p < 0.001). In the miconazole nitrate 0.25% group, improvement was most marked among those with moderate or severe diaper dermatitis at baseline and among patients whose baseline rashes were positive for C. albicans. Treatment with miconazole nitrate 0.25% was as safe as with ointment base alone. Miconazole nitrate 0.25% ointment is a safe and effective treatment for diaper dermatitis in infants.
Concannon
P
P
Royal North Shore Hospital, St. Leonards, New South Wales, Australia.
Gisoldi
E
E
Phillips
S
S
Grossman
R
R
D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002176:Candida albicans / Q000187:drug effects; D002177:Candidiasis / Q000150:complications / Q000188:drug therapy; D003231:Conjunctivitis / Q000139:chemically induced; D003963:Diaper Rash / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007223:Infant; D008297:Male; D008825:Miconazole / Q000009:adverse effects / Q000627:therapeutic use*; D010352:Patient Dropouts; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D000935:Antifungal Agents; D008825:Miconazole