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Evaluating the Effect of Bathing Additives in Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT04001855
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Other: Dilute vinegar (acetic acid) Other: Dilute bleach Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control split body study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effect of Bathing Additives in Atopic Dermatitis
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. 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/).

  2. 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/).

  3. 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.

  4. Skin culture swab [ Time Frame: Up to 21 days ]
    Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.

  5. 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).



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001855


Contacts
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Contact: UA Dermatology Clinical Trials Unit 520-694-1828 uadermatologyresearch@gmail.com

Locations
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United States, Arizona
Banner University Medicine Dermatology Recruiting
Tucson, Arizona, United States, 85718
Contact: UA Dermatology Clinical Trials Unit    520-694-1828    uadermatologyresearch@gmail.com   
Principal Investigator: Vivian Y Shi, MD         
Sponsors and Collaborators
University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT04001855     History of Changes
Other Study ID Numbers: 1906687954
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arizona:
Atopic Dermatitis
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Acetic Acid
Anti-Bacterial Agents
Anti-Infective Agents