NCT04101890

The Healthy Baby Bottoms Study

The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Linda Fu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diaper Dermatitis

Interventions

Type	Name	Description
DRUG	Diaper care with Theraworx	Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes

Timeline

• Start date: 2020-03-12
• Primary completion: 2021-01-02
• Completion: 2021-01-02
• First posted: 2019-09-24
• Last updated: 2021-12-17
• Results posted: 2021-12-17

Locations

1 site across 1 country: United States