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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bleach Bath and Moisturizers
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis

Eligibility Criteria

8 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UC Davis Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Group

Atopic Dermatitis Group

Arm Description

These subjects do not have atopic dermatitis and are considered healthy. They will participate in the bleach bath and the moisturizer application.

These subjects have atopic dermatitis and are considered healthy. They will participate in the bleach bath and the moisturizer application.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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..
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..
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..
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.
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.

Full Information

First Posted
July 10, 2014
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02594969
Brief Title
The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis
Acronym
AD
Official Title
The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Group
Arm Type
Active Comparator
Arm Description
These subjects do not have atopic dermatitis and are considered healthy. They will participate in the bleach bath and the moisturizer application.
Arm Title
Atopic Dermatitis Group
Arm Type
Experimental
Arm Description
These subjects have atopic dermatitis and are considered healthy. They will participate in the bleach bath and the moisturizer application.
Intervention Type
Other
Intervention Name(s)
Bleach Bath and Moisturizers
Other Intervention Name(s)
Hypochlorite Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in transepidermal water loss post-bath immersion
Description
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.
Time Frame
10 minutes post-bath immersion
Secondary Outcome Measure Information:
Title
Change in transepidermal water loss after moisturizer application
Description
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..
Time Frame
up to 60 minutes post-moisturizer application
Title
Change in skin hydration after moisturizer application
Description
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..
Time Frame
up to 60 minutes post-moisturizer application
Title
Change in skin pH after moisturizer application
Description
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..
Time Frame
up to 60 minutes post-moisturizer application
Title
Change in skin hydration post-bath immersion
Description
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.
Time Frame
10 minutes post-bath immersion
Title
Change in skin pH post-bath immersion
Description
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.
Time Frame
10 minutes post-bath immersion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15245365
Citation
Eichenfield LF. Consensus guidelines in diagnosis and treatment of atopic dermatitis. Allergy. 2004 Aug;59 Suppl 78:86-92. doi: 10.1111/j.1398-9995.2004.00569.x.
Results Reference
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PubMed Identifier
14988682
Citation
Hanifin JM, Cooper KD, Ho VC, Kang S, Krafchik BR, Margolis DJ, Schachner LA, Sidbury R, Whitmore SE, Sieck CK, Van Voorhees AS. Guidelines of care for atopic dermatitis, developed in accordance with the American Academy of Dermatology (AAD)/American Academy of Dermatology Association "Administrative Regulations for Evidence-Based Clinical Practice Guidelines". J Am Acad Dermatol. 2004 Mar;50(3):391-404. doi: 10.1016/j.jaad.2003.08.003. No abstract available. Erratum In: J Am Acad Dermatol. 2005 Jan;52(1):156.
Results Reference
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PubMed Identifier
15301569
Citation
Rippke F, Schreiner V, Doering T, Maibach HI. Stratum corneum pH in atopic dermatitis: impact on skin barrier function and colonization with Staphylococcus Aureus. Am J Clin Dermatol. 2004;5(4):217-23. doi: 10.2165/00128071-200405040-00002.
Results Reference
background
PubMed Identifier
23617366
Citation
Ryan C, Shaw RE, Cockerell CJ, Hand S, Ghali FE. Novel sodium hypochlorite cleanser shows clinical response and excellent acceptability in the treatment of atopic dermatitis. Pediatr Dermatol. 2013 May-Jun;30(3):308-15. doi: 10.1111/pde.12150.
Results Reference
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Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research

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

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