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The Healthy Baby Bottoms Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101890
Recruitment Status : Terminated (Principal Investigator left the Institution and decision was made by funders to terminate the trial.)
First Posted : September 24, 2019
Results First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Collaborator:
Avadim Technologies, Inc.
Information provided by (Responsible Party):
Linda Fu, Children's National Research Institute

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Rashes
Drug Information available for: Zinc oxide

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.



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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101890


Locations
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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:
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Responsible Party: Linda Fu, MD, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT04101890    
Other Study ID Numbers: 12239
First Posted: September 24, 2019    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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