Evaluating the Effect of Bathing Additives in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Evaluating the Effect of Bathing Additives in Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04001855
• Other study ID #: 1906687954
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	Banner University Medicine Dermatology	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Skin culture swab	Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.	Up to 21 days
Primary	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.