The Healthy Baby Bottoms Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Diaper Dermatitis
• Intervention / Treatment: Drug: Diaper care with Theraworx

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Chidlren's National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Read English at the 8th grade level
• Have reliable access to email for 7 weeks
• Complete the first online survey within 24 hours of the request
• Custodial guardian of an infant between the ages of 1-12 months old living with him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding recruitment

Exclusion Criteria:

• Does not have a stable address at which to receive a package of Theraworx and is unable/unwilling to pick it up at Children's National Health System
• Infant is immunocompromised, has a congenital disorder, or on the day of recruitment, has a diaper rash, has a moderate to severe illness requiring hospitalization or transfer to the emergency room, or was circumcised <10 days prior.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diaper care with Theraworx; Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks.	Drug: Diaper care with Theraworx; Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
No Intervention: Routine diaper care; Participants continue their typical diaper care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant	Caregivers self-report on a weekly basis the total number of days during the past week that their infant had a diaper rash. Diaper rash was defined as the presence of one or more of the following in the diaper region: redness, skin breakdown, papules or pustules. The total number of days with diaper rash for the entire 4 week period was summed from the 4 weekly surveys (outcome measure range: 0-28 days with fewer days representing a better outcome).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver's Self-report of Diaper Rash Severity	Caregivers used a modified Diaper Dermatitis Scale (Buckley, et al, Pediatric Dermatology 2016) to report infant diaper rash severity. The scale ranged from 0 (none) to 6 (most severe) with higher scores indicating a worse outcome. Items on the scale included assessments of rash size (0-2), redness (0-1), evidence of skin breakdown (0-1), evidence of papules (0-1) and evidence of pustules (0-1). Mean score was calculated using scores for every day over 28 days.	4 weeks

Collaborators and Investigators

• Sponsor: Linda Fu
• Collaborators: Avadim Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): January 2, 2021
• Study Completion (Actual): January 2, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Diaper Rash; Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents; Zinc Oxide
• Other Study ID Numbers: 12239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No