Diaper dermatitis is one of the most common dermatologic diseases affecting infants and
children. The incidence is highest among those 9-12 months old and it has been reported to
affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several
factors including: excessive moisture, topical irritants, reduced pH, friction, maceration
and bacterial infection. When infants soil their diaper, diaper contents saturate the area
raising the pH of the skin above the normal level of 5 or less, and leaving the area highly
vulnerable to maceration from friction. Irritants in urine and feces are then able to
penetrate the macerated skin, causing inflammation and greater skin friability. An elevation
in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the
skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam
Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for
temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such,
Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper
rash wounds, as well as for assisting with wound healing and reducing any associated pain.
The purpose of this study is to determine caregivers' perceptions of the benefits of using
Theraworx Foam on their infant's diaper area as part of their hygienic routine, including
whether they feel the product is pleasant and easy to use, and whether they feel it helps
prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.