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

May 25, 2017 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • UC Davis Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Group
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
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.
Other Names:
  • Hypochlorite Solution
Experimental: Atopic Dermatitis Group
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
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.
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
Time Frame: 10 minutes 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
Time Frame: up to 60 minutes post-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
Time Frame: up to 60 minutes post-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
Time Frame: up to 60 minutes post-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
Time Frame: 10 minutes 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
Time Frame: 10 minutes 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 523979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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