Skin benefits from continuous topical administration of a zinc oxide/petrolatum formulation by a novel disposable diaper.
BACKGROUND
Diaper dermatitis is a common childhood affliction. Aiming to help reduce the prevalence of this problem, we have advanced in our development of a novel diaper that delivers dermatological formulations to help protect the skin from over-hydration and irritation.


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


METHODS
All studies were independent, blinded, randomized clinical trials. Study A was conducted to confirm transfer of the zinc oxide/petrolatum (ZnO/Pet) formulation from the diaper to the child's skin during use. Children wore a single diaper for 3 h or multiple diapers for 24 h. After the use period, stratum corneum samples were taken from each child and analysed for ZnO/Pet. Study B evaluated the prevention of skin irritation and barrier damage from a standard skin irritant (SLS) in an adult arm model. Study C evaluated skin erythema and diaper rash in 268 infants over a 4-week usage period. One half of the infants used the ZnO/Pet diaper, while the other half used a control diaper that was identical except for the absence of the ZnO/Pet formulation.


RESULTS
The ointment formulation and ZnO transferred effectively from the diaper to the child's skin during product use. Transfer of ZnO increased from 4.2 microg/cm2 at 3 h to > 8 microg/cm2 at 24 h. Exposure to the formulations directly on adult skin prior to an irritant challenge was associated with up to a 3.5 reduction in skin barrier damage and skin erythema. Greatest reductions were seen for the ZnO containing formulations. Wearing of the formulation treated diaper was also associated with a significant reduction in skin erythema and diaper rash compared to the control product.


CONCLUSIONS
The results demonstrated the clinical benefits associated with continuous topical administration of a zinc oxide/petrolatum-based formulation by this novel diaper.
Baldwin
S
S
Procter & Gamble Co., Cincinnati, OH 45242, USA. Baldwins@pg.com
Odio
M R
MR
Haines
S L
SL
O'Connor
R J
RJ
Englehart
J S
JS
Lane
A T
AT
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage*; D003963:Diaper Rash / Q000517:prevention & control*; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004643:Emollients / Q000008:administration & dosage; D004890:Erythema; D005260:Female; D006801:Humans; D007223:Infant; D007224:Infant Care; D008875:Middle Aged; D010577:Petrolatum / Q000008:administration & dosage; D015034:Zinc Oxide / Q000008:administration & dosage*
D003879:Dermatologic Agents; D004643:Emollients; D010577:Petrolatum; D015034:Zinc Oxide