title: Continuous topical administration of a petrolatum formulation by a novel disposable diaper. 1. Effect on skin surface microtopography.
abstract: BACKGROUND
  Cutaneous problems are commonly associated with the use of diapers. Aiming to help reduce them, we have explored the use of the inner layer of diapers as a means to deliver to the skin dermatological formulations intended to help protect it from overhydration and irritation.
  
  
  OBJECTIVE
  To determine the feasibility of using the inner layer of the diaper as a vehicle for topical delivery of a petrolatum-based formulation and to determine its impact on skin surface microtopography.
  
  
  METHODS
  Two independent, blinded, randomized clinical trials were conducted, on children 16-24 months of age. All comparisons were done versus a control diaper, identical to the test product except for the absence of the petrolatum formulation. The studies determined the effects of the novel diaper on transfer of formulation to the skin and skin surface microtopography.
  
  
  RESULTS
  During normal diaper use, formulation transfer from the diaper to the skin occurred in a cumulative, time-dependent manner and use of the formulation-treated diaper was associated with significant reductions in skin surface roughness compared to the control diaper.
  
  
  CONCLUSIONS
  The results demonstrated the feasibility and 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.
authors.affiliation: Procter & Gamble Co., Cincinnati, Ohio 45242, USA. Odio.m@pg.com
authors.forename: M R
authors.initials: MR
authors.lastname: Odio
authors.forename: R J
authors.initials: RJ
authors.lastname: O'Connor
authors.forename: F
authors.initials: F
authors.lastname: Sarbaugh
authors.forename: S
authors.initials: S
authors.lastname: Baldwin
mesh_terms: D000287:Administration, Topical; D000704:Analysis of Variance; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007224:Infant Care; D008297:Male; D009823:Ointment Bases / Q000494:pharmacology*; D010577:Petrolatum / Q000494:pharmacology*; D012867:Skin / Q000187:drug effects; D017592:Skin Care / Q000379:methods; D012879:Skin Physiological Phenomena / Q000187:drug effects; D013997:Time Factors
chemical_list: D009823:Ointment Bases; D010577:Petrolatum