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

NCT ID: NCT02594969

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy Group

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

Group Type ACTIVE_COMPARATOR

Bleach Bath and Moisturizers

Intervention Type OTHER

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.

Atopic Dermatitis Group

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

Group Type EXPERIMENTAL

Bleach Bath and Moisturizers

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Hypochlorite Solution

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja K Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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UC Davis Department of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15245365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14988682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15301569 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23617366 (View on PubMed)

Related Links

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http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

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523979

Identifier Type: -

Identifier Source: org_study_id

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