Evaluating the Effect of Bathing Additives in Atopic Dermatitis

University of Arizona3 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

Dilute vinegar (acetic acid)OTHER

Dilute vinegar baths or gauze soaks

Dilute bleachOTHER

Dilute bleach baths or gauze soaks

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Banner University Medicine Dermatology

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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/).

Time frame: 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/).

Time frame: 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.

Time frame: Up to 21 days

Skin culture swab

Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.

Time frame: 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).

Time frame: Up to 21 days.

Data from ClinicalTrials.gov

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