Not provided
Not provided
Not provided
Not provided
Not provided
Investigator left university
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilute vinegar (acetic acid) | Other | Dilute vinegar baths or gauze soaks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medicine Dermatology | Tucson | Arizona | 85718 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| ID | Term |
|---|---|
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Randomized control split body study
Not provided
Not provided
Not provided
Not provided
| Dilute bleach | Other | Dilute bleach baths or gauze soaks |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |