Evaluating the Effect of Bathing Additives in Atopic Dermatitis

• ClinicalTrials.gov Identifier: NCT04001855
• Recruitment Status: Terminated
• First Posted: June 28, 2019
• Last Update Posted: June 4, 2021
• Sponsor: University of Arizona
• Information provided by (Responsible Party): University of Arizona

Tracking Information

• First Submitted Date: June 25, 2019
• First Posted Date: June 28, 2019
• Last Update Posted Date: June 4, 2021
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2019)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Effect of Bathing Additives in Atopic Dermatitis
• Official Title: Evaluating the Effect of Bathing Additives in Atopic Dermatitis
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized control split body study

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Atopic Dermatitis
• Eczema

Intervention

• Other: Dilute vinegar (acetic acid)
  Dilute vinegar baths or gauze soaks
• Other: Dilute bleach
  Dilute bleach baths or gauze soaks

Study Arms

• 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.
  Interventions:

  • Other: Dilute vinegar (acetic acid)
  • Other: Dilute bleach
• 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.
  Interventions:

  • Other: Dilute vinegar (acetic acid)
  • Other: Dilute bleach

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 1, 2021): 3
• Original Estimated Enrollment (submitted: June 26, 2019): 60
• Actual Study Completion Date: May 31, 2020
• Actual Primary Completion Date: May 31, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04001855
• Other Study ID Numbers: 1906687954
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Arizona
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Arizona
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Arizona
• Verification Date: June 2021