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

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ClinicalTrials.gov Identifier: NCT02594969
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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
Atopic Dermatitis Other: Bleach Bath and Moisturizers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Hypochlorite Solution




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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..

  2. 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..

  3. 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..

  4. 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.

  5. 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.



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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594969


Locations
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United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, MD UC Davis

Additional Information:
Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02594969     History of Changes
Other Study ID Numbers: 523979
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
atopic dermatitis

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents