Continuous topical administration of a petrolatum formulation by a novel disposable diaper - 1. Effect on skin surface microtopography

Background: Cutaneous problems are commonly associated with the use of diap ers. Aiming to help reduce them, we have explored the use of the inner laye r of diapers as a means to deliver to the skin dermatological formulations intended to help protect it from overhydration and irritation. Objective: T o determine the feasibility of using the inner layer of the diaper as a veh icle for topical delivery of a petrolatum-based formulation and to determin e its impact on skin surface microtopography. Methods: Two independent, bli nded, randomized clinical trials were conducted, on children 16-24 months o f age. All comparisons were done versus a control diaper, identical to the test product except for the absence of the petrolatum formulation. The stud ies determined the effects of the novel diaper on transfer of formulation t o the skin and skin surface microtopography. Results: During normal diaper use, formulation transfer from the diaper to the skin occurred in a cumulat ive, time-dependent manner and use of the formulation-treated diaper was as sociated with significant reductions in skin surface roughness compared to the control diaper. Conclusions: The results demonstrated the feasibility a nd skin surface benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. This unprecedented dosimetric approach offers new avenues to reduce further the dermatological problems commonly associated with diaper use. Copyright (C) 2000 S. Karger AG,Basel.