Atopic Dermatitis, Eczema
Conditions
Keywords
Atopic Dermatitis, Eczema
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.
Interventions
OTHERDilute vinegar (acetic acid)
Dilute vinegar baths or gauze soaks
OTHERDilute bleach
Dilute bleach baths or gauze soaks
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control split body study
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin barrier function - Transepidermal water loss (TEWL) | 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 | 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 | 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 | 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) | Up to 21 days. | Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD). |
Countries
United States
Outcome results
None listed