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 help reduce the prevalence of this problem, we have developed a novel diaper to deliver to the skin dermatological formulations intended to help protect the skin from overhydration and irritation.


OBJECTIVE
To determine the clinical benefits of a novel disposable diaper designed to deliver a petrolatum-based formulation continuously to the skin during use.


METHODS
Two independent, blinded, randomized clinical trials were conducted, involving an aggregate total of 391 children, 8-24 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 skin erythema and diaper rash.


RESULTS
Use of the formulation-treated diaper was associated with significant reductions in severity of erythema and diaper rash compared to the control product.


CONCLUSIONS
The results demonstrated the clinical benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. We anticipate that this advance in diaper design will contribute significantly to further reduce the prevalence and severity of irritant contact dermatitis in the diaper area.
Odio
M R
MR
Procter & Gamble Co., Cincinnati, Ohio 45242, USA. Odio.m@pg.com
O'Connor
R J
RJ
Sarbaugh
F
F
Baldwin
S
S
D000287:Administration, Topical; D000704:Analysis of Variance; D002675:Child, Preschool; D003963:Diaper Rash / Q000473:pathology / Q000517:prevention & control; D004311:Double-Blind Method; D004890:Erythema / Q000473:pathology / Q000517:prevention & control; D005260:Female; D006801:Humans; D007223:Infant; D007224:Infant Care; D008297:Male; D009823:Ointment Bases / Q000627:therapeutic use*; D010577:Petrolatum / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects / Q000473:pathology; D013997:Time Factors
D009823:Ointment Bases; D010577:Petrolatum