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Clinical Trial J Eur Acad Dermatol Venereol. 2010 Sep;24(9):1094-8.

doi: 10.1111/j.1468-3083.2010.03735.x. Epub 2010 Jun 9.

Efficacy and safety of two different antifungal pastes

in infants with diaper dermatitis: a randomized,
controlled study
P H Hoeger  1 , S Stark, G Jost

Affiliations
PMID: 20553355 DOI: 10.1111/j.1468-3083.2010.03735.x

Abstract
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.

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