The Healthy Baby Bottoms Study

• ClinicalTrials.gov Identifier: NCT04101890
• Recruitment Status: Terminated
• First Posted: September 24, 2019
• Results First Posted: December 17, 2021
• Last Update Posted: December 17, 2021
• Sponsor: Linda Fu
• Collaborator: Avadim Technologies, Inc.
• Information provided by (Responsible Party): Linda Fu, Children's National Research Institute

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diaper Dermatitis	Drug: Diaper care with Theraworx	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Healthy Baby Bottoms Study: A Trial of Theraworx Foam Formulation for the Prevention and Treatment of Diaper Dermatitis
• Actual Study Start Date: March 12, 2020
• Actual Primary Completion Date: January 2, 2021
• Actual Study Completion Date: January 2, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant [ Time Frame: 4 weeks ]
   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).

Secondary Outcome Measures :

1. Caregiver's Self-report of Diaper Rash Severity [ Time Frame: 4 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, District of Columbia

Chidlren's National Hospital

Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Linda Fu

Avadim Technologies, Inc.

  Study Documents (Full-Text)

Documents provided by Linda Fu, Children's National Research Institute:

Study Protocol and Statistical Analysis Plan  [PDF] January 13, 2020

More Information

• Responsible Party: Linda Fu, MD, Children's National Research Institute
• ClinicalTrials.gov Identifier: NCT04101890
• Other Study ID Numbers: 12239
• First Posted: September 24, 2019
• Results First Posted: December 17, 2021
• Last Update Posted: December 17, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis; Diaper Rash; Skin Diseases; Dermatitis, Irritant; Dermatitis, Contact; Skin Diseases, Eczematous; Zinc Oxide; Dermatologic Agents; Sunscreening Agents; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs