Skin benefits from continuous topical administration of a zinc oxide/petrolatum formulation by a novel disposable diaper

J Eur Acad Dermatol Venereol. 2001 Sep:15 Suppl 1:5-11. doi: 10.1046/j.0926-9959.2001.00002.x.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Dermatologic Agents / administration & dosage*
  • Diaper Rash / prevention & control*
  • Double-Blind Method
  • Drug Delivery Systems / instrumentation*
  • Emollients / administration & dosage
  • Erythema
  • Female
  • Humans
  • Infant
  • Infant Care*
  • Middle Aged
  • Petrolatum / administration & dosage
  • Zinc Oxide / administration & dosage*


  • Dermatologic Agents
  • Emollients
  • Petrolatum
  • Zinc Oxide