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Efficacy and safety of two different antifungal pastes in infants with diaper dermatitis: a randomized, controlled study.

Author(s): Hoeger PH, Stark S, Jost G

Affiliation(s): Department of Paediatric Dermatology, Catholic Children's Hospital Wilhelmstift, Hamburg, Germany. hoeger@kkh-wilhelmstift.de

Publication date & source: 2010-09, J Eur Acad Dermatol Venereol., 24(9):1094-8. Epub 2010 Jun 9.

BACKGROUND: Diaper dermatitis (DD) is the most common type of irritative dermatitis in infancy. It is frequently complicated by Candida superinfection. OBJECTIVE: Comparison of efficacy and safety of two antifungal pastes (Imazol = 1% clotrimazole; Multilind = 100,000 IU nystatin/g + 20% zinc oxide) in infants with DD. METHODS: A total of 96 infants were included in this multi-centre, controlled, randomized, evaluator-blinded phase IV trial and treated with pastes containing either clotrimazole (n = 45) or nystatin (n = 46) twice daily for 14 days. In all, 91 children (age 12.1 +/- 5.3 months; 48 females) with DD were evaluable. Total symptom score after 7 days (TSS7) was assessed as primary parameter. Secondary efficacy parameters were TSS at 14 days (TSS14), clinical and microbiological cure rates and global assessment (GA) of clinical response. RESULTS: TSS improved markedly with both pastes. Decreases in symptom score were 4.5 +/- 2.1 (day 7) and 6.1 +/- 1.9 (day 14) with clotrimazole compared with 4.2 +/- 2.3 and 5.4 +/- 2.4 with nystatin (P < 0.0001). With respect to TSS14, clotrimazole was superior to nystatin (P = 0.0434). Clinical cure rate was higher with clotrimazole [36.2% (day 7) and 68.1% (day 14)] compared with 28.6% and 46.9% (nystatin). GA was very good in 26 (55.3%) clotrimazole-treated children (nystatin: 16 [32.7%], P = 0.0257). Frequency of adverse events was comparable in both treatment groups. CONCLUSION: Clotrimazole was superior to nystatin with respect to reduction in symptom score and GA. Microbiological cure rate was 100% for both agents. Both treatments were safe and well-tolerated.

Page last updated: 2010-10-05

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