Efficacy of topical sucralfate versus topical zinc oxide in diaper dermatitis: a randomized, double blind study

Diaper rash is a common but non life threatening condition during infancy. Different modalities of treatment are suggested. Sucralfate acts as a physical barrier to irritants and has antibacterial activities. Promising reports of the effect of topical sucralfate on wound epithelialization along with its bacteriostatic properties led us to carry out a trial to evaluateits role as a topical agent in the treatment of diaper dermatitis and compare its efficacy with topical zinc oxide. This double blind randomized clinical trial was conducted in Shariati hospital from April 2008 to September 2009. Sucralfate and zinc oxide were formulated as 20% ointments with the same excipients. All patients were randomly treated topically with either sucralfate (N=25) or zinc oxide (N=21) for 7 days. Diaper severity scores were obtained before treatment and at days 3, 5, 7 by the authors. A total of 46 infants (54.3% female and 45.7% male) with mean age of 4.4±6.5 months entered the study. The mean age,sex, frequency of diaper change (per day) and everity of diaper rash showed no statistically significant difference between two groups. Sucralfate 20% ointment was significantly superior in healing diaper dermatitis at days 5 and 7 (p < 0.05 and 0.01respectively) and showed a significantly shorter healing time (3.24+/-2.02 days) in comparison with zinc oxide 20% ointment (5.42+/-2.39 days) (P = 0.002). Since sucralfate in topical formulations acts as a physical barrier with proved safety and no noticeable absorption,it may be used as a potential treatment for diaper dermatitis.