Evaluating the Effect of Bathing Additives in Atopic Dermatitis

June 1, 2021 updated by: University of Arizona
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Banner University Medicine Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Dilute vinegar (acetic acid)
Dilute vinegar baths or gauze soaks
Other: Dilute bleach
Dilute bleach baths or gauze soaks
Experimental: 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.
Other: Dilute vinegar (acetic acid)
Dilute vinegar baths or gauze soaks
Other: Dilute bleach
Dilute bleach baths or gauze soaks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin barrier function - Transepidermal water loss (TEWL)
Time Frame: 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/).
Up to 21 days
Skin barrier function - Stratum corneum hydration
Time Frame: 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/).
Up to 21 days
Skin barrier function - pH
Time Frame: Up to 21 days
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Up to 21 days
Skin culture swab
Time Frame: Up to 21 days
Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
Up to 21 days
Change in Eczema Area and Severity Index (EASI)
Time Frame: Up to 21 days.
Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).
Up to 21 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1906687954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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