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Diaper Dermatitis: A Therapeutic Dilemma. Results of a Double‐Blind Placebo Controlled Trial of Miconazole Nitrate 0.25%
Author(s) -
Concan Patrick,
Gisoldi Elvira,
Phillips Steven,
Grossman Rachel
Publication year - 2001
Publication title -
pediatric dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.542
H-Index - 73
eISSN - 1525-1470
pISSN - 0736-8046
DOI - 10.1046/j.1525-1470.2001.018002149.x
Subject(s) - miconazole nitrate , medicine , diaper dermatitis , miconazole , rash , dermatology , placebo , adverse effect , randomized controlled trial , antifungal , pathology , alternative medicine
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.