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

Background: 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 evaluate its role as a topical agent in the treatment of diaper dermatitis and compare its efficacy with topical zinc oxide. Method: 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. Result: 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 severity 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 0.01 respectively) 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). Conclusion: 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.