Evaluating the Effect of Bathing Additives in Atopic Dermatitis

Not Applicable

Terminated

• Conditions: Eczema; Atopic Dermatitis
• Interventions: Other: Dilute vinegar (acetic acid); Other: Dilute bleach

• Registration Number: NCT04001855
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Study Start: 2019-07-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Exclusion Criteria

• Subjects who do not fit the inclusion criteria
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilute vinegar vs. dilute bleach gauze soaks	Dilute vinegar (acetic acid)	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.
Dilute vinegar vs. dilute bleach bath	Dilute bleach	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.
Dilute vinegar vs. dilute bleach bath	Dilute vinegar (acetic acid)	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.
Dilute vinegar vs. dilute bleach gauze soaks	Dilute bleach	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.

Primary Outcome Measures

Name	Time	Method
Skin culture swab	Up to 21 days	Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
Skin barrier function - Transepidermal water loss (TEWL)	Up to 21 days	Assess skin barrier function through measurement of transepidermal water loss (in g/m\^2h) using a commercially-available, non-invasive device (Delfin VapoMeter: http://www.delfintech.com/en/product_information/vapometer/).
Skin barrier function - pH	Up to 21 days	Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Skin barrier function - Stratum corneum hydration	Up to 21 days	Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device (Delfin MoistureMeterSC: http://www.delfintech.com/en/product_information/moisturemetersc/).
Change in Eczema Area and Severity Index (EASI)	Up to 21 days.	Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).

Trial Locations

Locations (1)

Banner University Medicine Dermatology; 🇺🇸 Tucson, Arizona, United States