Evaluating the Effect of Bathing Additives in Atopic Dermatitis

NCT ID: NCT04001855

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-05-31

Brief Summary

This proposed project will be an open-label, split-arm, randomized controlled pilot study. Up to 60 patients diagnosed with atopic dermatitis (eczema) will be enrolled in the study. The purpose of this study is to understand the change in skin barrier function and skin microbial composition in patients with atopic dermatitis following dilute bleach bath/soak and dilute vinegar bath/soak.

Detailed Description

Atopic dermatitis (AD), also known as eczema, is an inflammatory skin condition that affects children and adults and causes skin redness, dryness and itching. Dilute bleach baths are standard of care for treatment of AD and work to decrease skin inflammation and modulate the skin microbiome. Dilute vinegar (acetic acid) has been reported to have similar effects on the skin. The purpose of this study is to evaluate the change in skin barrier function and skin microbial composition following baths or gauze soaks with dilute bleach and dilute vinegar.

Conditions

Atopic Dermatitis; Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dilute vinegar vs. dilute bleach bath

Subjects will complete a total of 5 study visits over 11 days. At visits 1-4, subjects will soak their forearms in either dilute bleach or dilute vinegar for 10 minutes. At all visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected.

Group Type: EXPERIMENTAL

Dilute vinegar (acetic acid)

Intervention Type: OTHER

Dilute vinegar baths or gauze soaks

Dilute bleach

Intervention Type: OTHER

Dilute bleach baths or gauze soaks

Dilute vinegar vs. dilute bleach gauze soaks

Subjects will complete a total of two study visits over 21 days, and will be instructed to apply gauze soaks daily at home over the 21-day study period. At baseline and 21-day follow-up visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected. Subjects will also be provided with a non-invasive skin barrier measurement device to take daily recordings at home.

Group Type: EXPERIMENTAL

Dilute vinegar (acetic acid)

Intervention Type: OTHER

Dilute vinegar baths or gauze soaks

Dilute bleach

Intervention Type: OTHER

Dilute bleach baths or gauze soaks

Interventions

Dilute vinegar (acetic acid)

Dilute vinegar baths or gauze soaks

Intervention Type: OTHER

Dilute bleach

Dilute bleach baths or gauze soaks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males and females, at least 5 years of age
• Subjects, parents/legal guardians must be able to comprehend and read the English language
• Subjects must have a diagnosis of atopic dermatitis (AD) by a board-certified dermatologist

• Subjects unable or unwilling to comply with the study procedures
• Concurrently have other inflammatory skin conditions
• Prior known allergies to any components of the materials used
• A subject who in the opinion of the investigator will be uncooperative or unable to comply with study procedures
• Subject unable to speak or read the English language
• Those that are pregnant, prisoners or cognitively impaired

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Banner University Medicine Dermatology

Tucson, Arizona, United States

Countries

United States

Other Identifiers

1906687954

Identifier Type: -

Identifier Source: org_study_id