Continuous topical administration of a petrolatum formulation by a novel disposable diaper - 2. Effect on skin condition

Background: Diaper dermatitis is a common childhood affliction. Aiming to h elp reduce the prevalence of this problem, we have developed a novel diaper to deliver to the skin dermatological formulations intended to help protec t the skin from overhydration and irritation. Objective: To determine the c linical benefits of a novel disposable diaper designed to deliver a petrola tum-based formulation continuously to the skin during use. Methods: Two ind ependent, blinded, randomized clinical trials were conducted, involving an aggregate total of 391 children, 8-24 months of age. All comparisons were d one versus a control diaper, identical to the test product except for the a bsence of the petrolatum formulation. The studies determined the effects of the novel diaper on skin erythema and diaper rash. Results: Use of the for mulation-treated diaper was associated with significant reductions in sever ity of erythema and diaper rash compared to the control product. Conclusion s: The results demonstrated the clinical benefits associated with continuou s topical administration of a petrolatum-based formulation by this novel di aper. We anticipate that this advance in diaper design will contribute sign ificantly to further reduce the prevalence and severity of irritant contact dermatitis in the diaper area. Copyright (C) 2000 S. Karger AG,Basel.