Bleach Bath Treatment of Adults With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bleach bath (sodium hypochlorite)
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema, bleach bath, itch, skin barrier, staphylococcus aureus
Eligibility Criteria
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.
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.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dilute bleach bath
Arm Description
Subjects will take a diluted bleach bath (0.005% Sodium hypochlorite) for 5-10 minutes twice a week for 12 weeks.
Outcomes
Primary Outcome Measures
Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping
TEWL will be measured at 3 timepoints throughout the study.
Secondary Outcome Measures
Itch - 5D pruritus scale
Change in self reported itch using a validated assessment tool.
Skin permeability
amount of fluorescent labeled molecule passage through the epithelial layer ex-vivo
Transepithelial electrical resistance
change of epithelium membrane potential and resistance in millivolts ex-vivo
Tissue expression of relevant inflammatory and epidermal barrier markers
Messenger ribonucleic acid (mRNA) expression of key inflammatory mediators and epidermal barrier proteins performed on the biopsy specimens
Skin bacterial diversity
Change in diversity of bacteria present in the skin
Full Information
NCT ID
NCT01996150
First Posted
November 12, 2013
Last Updated
January 12, 2018
Sponsor
University of Rochester
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Eczema Association
1. Study Identification
Unique Protocol Identification Number
NCT01996150
Brief Title
Bleach Bath Treatment of Adults With Atopic Dermatitis
Official Title
Assessing the Impact of Bleach Baths on Itch, Cutaneous Inflammation, Microbial Flora and Skin Barrier Function in Adult Atopic Dermatitis Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Eczema Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
Bleach baths will improve validated measures of pruritus (itch).
Bleach baths will diminish the local T-helper 2 (Th2) immune response measured from skin biopsy samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, eczema, bleach bath, itch, skin barrier, staphylococcus aureus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dilute bleach bath
Arm Type
Experimental
Arm Description
Subjects will take a diluted bleach bath (0.005% Sodium hypochlorite) for 5-10 minutes twice a week for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bleach bath (sodium hypochlorite)
Other Intervention Name(s)
Sodium hypochlorite
Intervention Description
Subjects will take diluted bleach bath (0.005% Sodium Hypochlorite) for 5-10 minutes twice a week for 12 weeks.
Primary Outcome Measure Information:
Title
Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping
Description
TEWL will be measured at 3 timepoints throughout the study.
Time Frame
change from baseline after 12 weeks of bleach baths
Secondary Outcome Measure Information:
Title
Itch - 5D pruritus scale
Description
Change in self reported itch using a validated assessment tool.
Time Frame
change from baseline after 12 weeks of bleach baths
Title
Skin permeability
Description
amount of fluorescent labeled molecule passage through the epithelial layer ex-vivo
Time Frame
change from baseline after 12 weeks of bleach baths
Title
Transepithelial electrical resistance
Description
change of epithelium membrane potential and resistance in millivolts ex-vivo
Time Frame
change from baseline after 12 weeks of bleach baths
Title
Tissue expression of relevant inflammatory and epidermal barrier markers
Description
Messenger ribonucleic acid (mRNA) expression of key inflammatory mediators and epidermal barrier proteins performed on the biopsy specimens
Time Frame
change from baseline after 12 weeks of bleach baths
Title
Skin bacterial diversity
Description
Change in diversity of bacteria present in the skin
Time Frame
change from baseline after 12 weeks of bleach baths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Beck, MD
Organizational Affiliation
Department of Dermatology University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19403473
Citation
Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
Results Reference
background
PubMed Identifier
22310478
Citation
Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.
Results Reference
background
PubMed Identifier
21163515
Citation
De Benedetto A, Rafaels NM, McGirt LY, Ivanov AI, Georas SN, Cheadle C, Berger AE, Zhang K, Vidyasagar S, Yoshida T, Boguniewicz M, Hata T, Schneider LC, Hanifin JM, Gallo RL, Novak N, Weidinger S, Beaty TH, Leung DY, Barnes KC, Beck LA. Tight junction defects in patients with atopic dermatitis. J Allergy Clin Immunol. 2011 Mar;127(3):773-86.e1-7. doi: 10.1016/j.jaci.2010.10.018. Epub 2010 Dec 15.
Results Reference
background
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Bleach Bath Treatment of Adults With Atopic Dermatitis
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