The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The goal is this study is to investigate the effects of dilute bleach on the skin of subjects with atopic dermatitis and those with healthy skin. The second goal is to evaluate the effects of different moisturizers on the skin barrier of subjects with and without atopic dermatitis. The investigators hypothesize that the bleach bath will increase the skin pH, decrease the skin hydration, and increase skin water loss in all study subjects. Secondly, the investigators hypothesize that moisturizers with the lowest pH and the highest water to oil ratio will result in improved skin barrier function. Furthermore, the investigators believe there will be a greater improvement in patients with atopic dermatitis.

Detailed Description
-----------------
The study has two main parts. Subjects in both groups will have one forearm in a dilute bleach bath and the other arm in a water bath for 10 minutes. The change in skin will be measured using different painless devices. The second part of the study involves application of 4 various moisturizers. The change in skin will be measured over a period of time using the non-invasive devices.

Official Title
-----------------
The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Other: Bleach Bath and Moisturizers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 8 years to 65 years Has been diagnosed with atopic dermatitis by a board-certified dermatologist at UC Davis Subject/parents/legal guardians able to read and comprehend the study procedure and consent forms. Exclusion Criteria: Those who are pregnant, prisoners, or cognitively impaired Those who do not fit the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Group<br>These subjects do not have atopic dermatitis and are considered healthy. They will participate in the bleach bath and the moisturizer application. | Other: Bleach Bath and Moisturizers<br>* All subjects will have one forearm in a bleach bath and the other forearm in a water bath for 10 minutes. Following the bath, skin barrier function will be evaluated. Secondly, moisturizers will be applied to the arms and the skin barrier will be evaluated overtime.<br>* Other names: Hypochlorite Solution;|
| Experimental: Atopic Dermatitis Group<br>These subjects have atopic dermatitis and are considered healthy. They will participate in the bleach bath and the moisturizer application. | Other: Bleach Bath and Moisturizers<br>* All subjects will have one forearm in a bleach bath and the other forearm in a water bath for 10 minutes. Following the bath, skin barrier function will be evaluated. Secondly, moisturizers will be applied to the arms and the skin barrier will be evaluated overtime.<br>* Other names: Hypochlorite Solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transepidermal water loss post-bath immersion | Subjects will immerse one randomized arm in a bleach bath and the other arm in a water bath for 10 minutes. The skin barrier function will be evaluated for change in transepidermal water loss after 10 minutes of bath immersion. | 10 minutes post-bath immersion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transepidermal water loss after moisturizer application | Each subject will have 4 various moisturizers placed on each arm. The skin barrier function will be measured for change in transepidermal water loss to 60 minutes post-application.. | up to 60 minutes post-moisturizer application | 
| Change in skin hydration after moisturizer application | Each subject will have 4 various moisturizers placed on each arm. The skin barrier function will be measured for change in skin hydration up to 60 minutes post-application.. | up to 60 minutes post-moisturizer application | 
| Change in skin pH after moisturizer application | Each subject will have 4 various moisturizers placed on each arm. The skin barrier function will be measured for change in skin pH up to 60 minutes post-application.. | up to 60 minutes post-moisturizer application | 
| Change in skin hydration post-bath immersion | Subjects will immerse one randomized arm in a bleach bath and the other arm in a water bath for 10 minutes. The skin barrier function will be evaluated for change in skin hydration after 10 minutes of bath immersion. | 10 minutes post-bath immersion | 
| Change in skin pH post-bath immersion | Subjects will immerse one randomized arm in a bleach bath and the other arm in a water bath for 10 minutes. The skin barrier function will be evaluated for change in skin pH after 10 minutes of bath immersion. | 10 minutes post-bath immersion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atopic dermatitis