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Skin benefits from continuous topical administration of a zinc oxide/petrolatum formulation by a novel disposable diaper
Author(s) -
Baldwin S,
Odio M R,
Haines S L,
O'Connor R J,
Englehart J S,
Lane A T
Publication year - 2001
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1046/j.0926-9959.2001.00002.x
Subject(s) - diaper dermatitis , medicine , dermatology , stratum corneum , skin irritation , irritation , erythema , shampoo , skin barrier , rash , surgery , pathology , immunology
Abstract 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 µg/cm 2 at 3 h to > 8 µg/cm 2 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.