Back to resultsEvaluating the Effect of Bathing Additives in Atopic Dermatitis
Primary Purpose
Atopic Dermatitis, Eczema
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dilute vinegar (acetic acid)
Dilute bleach
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Eczema
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
Sites / Locations
- Banner University Medicine Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dilute vinegar vs. dilute bleach bath
Dilute vinegar vs. dilute bleach gauze soaks
Arm 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.
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.
Outcomes
Primary Outcome Measures
Skin barrier function - Transepidermal water loss (TEWL)
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 - Stratum corneum hydration
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/).
Skin barrier function - pH
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Skin culture swab
Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
Change in Eczema Area and Severity Index (EASI)
Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04001855
Brief Title
Evaluating the Effect of Bathing Additives in Atopic Dermatitis
Official Title
Evaluating the Effect of Bathing Additives in Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Investigator left university
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
Atopic Dermatitis, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control split body study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dilute vinegar vs. dilute bleach bath
Arm Type
Experimental
Arm 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 Title
Dilute vinegar vs. dilute bleach gauze soaks
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Dilute vinegar (acetic acid)
Intervention Description
Dilute vinegar baths or gauze soaks
Intervention Type
Other
Intervention Name(s)
Dilute bleach
Intervention Description
Dilute bleach baths or gauze soaks
Primary Outcome Measure Information:
Title
Skin barrier function - Transepidermal water loss (TEWL)
Description
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/).
Time Frame
Up to 21 days
Title
Skin barrier function - Stratum corneum hydration
Description
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/).
Time Frame
Up to 21 days
Title
Skin barrier function - pH
Description
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Time Frame
Up to 21 days
Title
Skin culture swab
Description
Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
Time Frame
Up to 21 days
Title
Change in Eczema Area and Severity Index (EASI)
Description
Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).
Time Frame
Up to 21 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Banner University Medicine Dermatology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effect of Bathing Additives in Atopic Dermatitis
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