Document Detail

Diaper dermatitis: a therapeutic dilemma. Results of a double-blind placebo controlled trial of miconazole nitrate 0.25%.
MedLine Citation:
PMID:  11358560     Owner:  NLM     Status:  MEDLINE    
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.
P Concannon; E Gisoldi; S Phillips; R Grossman
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Pediatric dermatology     Volume:  18     ISSN:  0736-8046     ISO Abbreviation:  Pediatr Dermatol     Publication Date:    2001 Mar-Apr
Date Detail:
Created Date:  2001-05-18     Completed Date:  2001-07-26     Revised Date:  2009-03-03    
Medline Journal Info:
Nlm Unique ID:  8406799     Medline TA:  Pediatr Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  149-55     Citation Subset:  IM    
Royal North Shore Hospital, St. Leonards, New South Wales, Australia.
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MeSH Terms
Antifungal Agents / adverse effects,  therapeutic use*
Candida albicans / drug effects
Candidiasis / complications,  drug therapy
Conjunctivitis / chemically induced
Diaper Rash / complications,  drug therapy*,  pathology
Double-Blind Method
Fever / chemically induced
Miconazole / adverse effects,  therapeutic use*
Patient Dropouts
Severity of Illness Index
Skin / drug effects,  pathology
Time Factors
Treatment Outcome
Vomiting / chemically induced
Reg. No./Substance:
0/Antifungal Agents; 22916-47-8/Miconazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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