Evaluating the Effect of Bathing Additives in Atopic Dermatitis

NCT04001855 | Terminated

• 1 other identifier: 1906687954
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Keywords

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (5)

• 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/).

  Up to 21 days

• 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/).

  Up to 21 days

• Skin barrier function - pH

  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

  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)

  Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).

  Up to 21 days.

Study Arms (2)

Dilute vinegar vs. dilute bleach bath

EXPERIMENTAL

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); Other: Dilute bleach

Dilute vinegar vs. dilute bleach gauze soaks

EXPERIMENTAL

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); Other: Dilute bleach

Interventions

Dilute vinegar (acetic acid) OTHER

Dilute vinegar baths or gauze soaks

Dilute vinegar vs. dilute bleach bath; Dilute vinegar vs. dilute bleach gauze soaks

Dilute bleach OTHER

Dilute bleach baths or gauze soaks

Dilute vinegar vs. dilute bleach bath; Dilute vinegar vs. dilute bleach gauze soaks

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medicine Dermatology

Tucson, Arizona, 85718, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control split body study

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 28, 2019
• Study Start: July 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)