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The Healthy Baby Bottoms Study

NCT ID: NCT04101890

Last Updated: 2021-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2021-01-02

Brief Summary

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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.

Detailed Description

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Conditions

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Diaper Dermatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diaper care with Theraworx

Intervention Type DRUG

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

Routine diaper care

Participants continue their typical diaper care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diaper care with Theraworx

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avadim Technologies, Inc.

INDUSTRY

Sponsor Role collaborator

Linda Fu

OTHER

Sponsor Role lead

Responsible Party

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Linda Fu

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chidlren's National Hospital

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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12239

Identifier Type: -

Identifier Source: org_study_id