S. Baldwin et al., Skin benefits from continuous topical administration of a zinc oxide/petrolatum formulation by a novel disposable diaper, J EUR A D V, 15, 2001, pp. 5-11
Citations number
23
Categorie Soggetti
Dermatology
Journal title
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Background Diaper dermatitis is a common childhood affliction. Aiming to he
lp reduce the prevalence of this problem, we have advanced in our developme
nt of a novel diaper that delivers dermatological formulations to help prot
ect the skin from over-hydration and irritation.
Objective To determine the clinical benefits of a novel disposable diaper d
esigned to deliver a zinc oxide and petrolatum-based formulation continuous
ly 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. Childre
n 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 d
iaper to the child's skin during product use. Transfer of ZnO increased fro
m 4.2 mug/cm(2) at 3 h to > 8 mug/cm(2) at 24 h. Exposure to the formulatio
ns directly on adult skin prior to an irritant challenge was associated wit
h 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 fo
rmulation treated diaper was also associated with a significant reduction i
n 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 formul
ation by this novel diaper.