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

Diaper dermatitis (DD) is the most common type of irritative dermatitis in infancy. It is frequently complicated by Candida superinfection.

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.

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.

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.

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.