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

NCT02594969 | Completed

• 1 other identifier: 523979
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in transepidermal water loss after moisturizer application

  up to 60 minutes post-moisturizer application

• Change in skin hydration after moisturizer application

  up to 60 minutes post-moisturizer application

• Change in skin pH after moisturizer application

  up to 60 minutes post-moisturizer application

• Change in skin hydration post-bath immersion

  10 minutes post-bath immersion

• Change in skin pH post-bath immersion

  10 minutes post-bath immersion

Study Arms (2)

Healthy Group

ACTIVE COMPARATOR

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

Atopic Dermatitis Group

EXPERIMENTAL

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

Interventions

Bleach Bath and Moisturizers 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.

Also known as: Hypochlorite Solution

Atopic Dermatitis Group; Healthy Group

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those who are pregnant, prisoners, or cognitively impaired

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (4)

• 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.

  PMID: 15245365 BACKGROUND

• 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.

  PMID: 14988682 BACKGROUND

• 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.

  PMID: 15301569 BACKGROUND

• 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.

  PMID: 23617366 BACKGROUND

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Raja K Sivamani, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: November 3, 2015
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)