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.