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

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT02594969
Collaborator
(none)
20
1
2
15.9
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bleach Bath and Moisturizers
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in transepidermal water loss post-bath immersion [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.

    Secondary Outcome Measures

    1. Change in transepidermal water loss after moisturizer application [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..

    2. Change in skin hydration after moisturizer application [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..

    3. Change in skin pH after moisturizer application [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..

    4. Change in skin hydration post-bath immersion [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.

    5. Change in skin pH post-bath immersion [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Davis Department of Dermatology Sacramento California United States 95816

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

    • Principal Investigator: Raja K Sivamani, MD, UC Davis

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT02594969
    Other Study ID Numbers:
    • 523979
    First Posted:
    Nov 3, 2015
    Last Update Posted:
    May 30, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by University of California, Davis
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 30, 2017