Evaluating the Effect of Bathing Additives in Atopic Dermatitis

Evaluating the Effect of Bathing Additives in Atopic Dermatitis

Sponsors

Lead sponsor: University of Arizona

Source 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.

Overall Status Recruiting
Start Date July 1, 2019
Completion Date July 1, 2022
Primary Completion Date July 1, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Skin barrier function - Transepidermal water loss (TEWL) Up to 21 days
Skin barrier function - Stratum corneum hydration Up to 21 days
Skin barrier function - pH Up to 21 days
Skin culture swab Up to 21 days
Change in Eczema Area and Severity Index (EASI) Up to 21 days.
Enrollment 60
Condition
Intervention

Intervention type: Other

Intervention name: Dilute vinegar (acetic acid)

Description: Dilute vinegar baths or gauze soaks

Intervention type: Other

Intervention name: Dilute bleach

Description: Dilute bleach baths or gauze soaks

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

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

Gender: All

Minimum age: 5 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: UA Dermatology Clinical Trials Unit

Phone: 520-694-1828

Email: [email protected]

Location
facility status contact investigator Banner University Medicine Dermatology UA Dermatology Clinical Trials Unit 520-694-1828 [email protected] Vivian Y Shi, MD Principal Investigator
Location Countries

United States

Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Dilute vinegar vs. dilute bleach bath

Arm group type: Experimental

Description: 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.

Arm group label: Dilute vinegar vs. dilute bleach gauze soaks

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized control split body study

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov