Bleach Bath Treatment of Adults With Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: bleach bath (sodium hypochlorite)

• Registration Number: NCT01996150
• Lead Sponsor: University of Rochester

Brief Summary

This is pilot, mechanistic study to address whether bleach baths given to adult subjects with atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will significantly alter their skin microbiome and in so doing improve their skin barrier, diminish expression of inflammatory proteins in the skin and improve itch. To answer these questions the investigators will perform a 3-month, pilot, investigator-initiated, single-center, open-label clinical study. This study will allow us to test the following hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths will diminish the local inflammatory response in the skin, and 3) that bleach baths will improve validated measures of itch (also called pruritus).

Detailed Description

Atopic Dermatitis subjects have different proportions of bacterial communities on their skin surface. Often, their skin is colonized with the pathogenic bacteria called Staphylococcus aureus. Studies have demonstrated a remarkable clinical improvement in Atopic Dermatitis subjects who take bleach baths two times per week for three months. The assumption was that this worked by reducing the S. aureus on the skin surface but by standard culture techniques there was no change in S. aureus colonization. Therefore, the mechanism by which these bleach baths improved the disease remains entirely unknown. This study will assess the effects bleach baths have on bacteria that can and cannot be cultured using new molecular biologic tools that have shown us that the skin is home to thousands of different microbial species. This bacterial ecosystem is called the microbiome. The investigators will also determine whether bleach baths affect skin barrier integrity and the cutaneous expression of lymphocyte-derived cytokines that are thought to cause the skin inflammation in subjects with Atopic Dermatitis. The investigators will also assess to what degree these baths improve disease severity and the symptoms of itch using validated scoring systems. This work will likely uncover new ideas about the pathogenesis of Atopic Dermatitis and may be the first step to developing new pro-microbial and antimicrobial therapeutics.

This study is designed to test the following hypotheses:

1. The chronic use of bleach baths will normalize skin barrier function in adult Atopic Dermatitis subjects as measured by physiological measures of barrier in vivo, and as assessed by ex vivo studies (measuring transepithelial electrical resistance (TEER) and permeability of the epidermis from skin biopsies). The investigators will evaluate whether any of the functional changes correlate with changes in expression of relevant tight and intercellular junction molecules at the messenger ribonucleic acid (mRNA) level.

2. Bleach baths will improve validated measures of pruritus (itch).

3. Bleach baths will diminish the local T-helper 2 (Th2) immune response measured from skin biopsy samples.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Study Start: 2014-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Moderate to severe Atopic dermatitis: Eczema Area and Severity Index (EASI) score ≥ 10.
• Skin culture positive for Staphylococcus aureus
• Must have active skin disease on the day of enrollment.

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Exclusion Criteria

• Unwillingness or inability to complete informed consent
• Lidocaine or Novocain allergy
• History of keloid formation
• Course of systemic antibiotics or antivirals within 2 weeks prior to enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dilute bleach bath	bleach bath (sodium hypochlorite)	Subjects will take a diluted bleach bath (0.005% Sodium hypochlorite) for 5-10 minutes twice a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping	change from baseline after 12 weeks of bleach baths	TEWL will be measured at 3 timepoints throughout the study.

Secondary Outcome Measures

Name	Time	Method
Skin permeability	change from baseline after 12 weeks of bleach baths	amount of fluorescent labeled molecule passage through the epithelial layer ex-vivo
Itch - 5D pruritus scale	change from baseline after 12 weeks of bleach baths	Change in self reported itch using a validated assessment tool.
Transepithelial electrical resistance	change from baseline after 12 weeks of bleach baths	change of epithelium membrane potential and resistance in millivolts ex-vivo
Tissue expression of relevant inflammatory and epidermal barrier markers	change from baseline after 12 weeks of bleach baths	Messenger ribonucleic acid (mRNA) expression of key inflammatory mediators and epidermal barrier proteins performed on the biopsy specimens
Skin bacterial diversity	change from baseline after 12 weeks of bleach baths	Change in diversity of bacteria present in the skin

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States