The Healthy Baby Bottoms Study

NCT04101890 | Terminated Phase 4 Results DMC

• 1 other identifier: 12239
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaper Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Caregiver's Self-report of Diaper Rash Severity

  4 weeks

Study Arms (2)

Diaper care with Theraworx

EXPERIMENTAL

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

Routine diaper care

NO INTERVENTION

Participants continue their typical diaper care.

Interventions

Diaper care with Theraworx DRUG

Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes

Diaper care with Theraworx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linda Fu: lead
• Avadim Technologies, Inc.: collaborator

Study Sites (1)

Chidlren's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Diaper Rash

Interventions

Zinc Oxide

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Results Point of Contact

• Title: Elena Gibson
• Organization: Children's Research Institute

egibson@cnmc.org

(202) 476-6877

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 24, 2019
• Study Start: March 12, 2020
• Primary Completion: January 2, 2021
• Study Completion: January 2, 2021
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)