Hoeger PH, Stark S, Jost G, et al.
Journal of the European Academy of Dermatology and Venereology : JEADV. Date of publication 2010 Sep 1;volume 24(9):1094-8.
1. 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.
Hoeger PH(1), Stark S, Jost G.
Author information:
(1)Department of Paediatric Dermatology, Catholic Children's Hospital
Wilhelmstift, Hamburg, Germany. hoeger@kkh-wilhelmstift.de
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.
DOI: 10.1111/j.1468-3083.2010.03735.x
PMID: 20553355 [Indexed for MEDLINE]
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