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

Atopic Dermatitis Clinical Trial

— AD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594969
• Other study ID #: 523979
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: May 25, 2017
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
United States	UC Davis Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (4)

Eichenfield LF. Consensus guidelines in diagnosis and treatment of atopic dermatitis. Allergy. 2004 Aug;59 Suppl 78:86-92. — View 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. Erratum in: J Am Acad Dermatol. 2005 Jan;52(1):156. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes post-bath immersion
Secondary	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..	up to 60 minutes post-moisturizer application
Secondary	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..	up to 60 minutes post-moisturizer application
Secondary	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..	up to 60 minutes post-moisturizer application
Secondary	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.	10 minutes post-bath immersion
Secondary	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.	10 minutes post-bath immersion

External Links

•   University of California-Davis Department of Dermatology Clinical Research