Bleach Bath Treatment of Adults With Atopic Dermatitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of Rochester
Sponsor:
Collaborators:
National Eczema Association
Information provided by (Responsible Party):
Lisa Beck, University of Rochester
ClinicalTrials.gov Identifier:
NCT01996150
First received: November 12, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Atopic Dermatitis
Drug: bleach bath (sodium hypochlorite)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Impact of Bleach Baths on Itch, Cutaneous Inflammation, Microbial Flora and Skin Barrier Function in Adult Atopic Dermatitis Subjects

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping [ Time Frame: change from baseline after 12 weeks of bleach baths ] [ Designated as safety issue: No ]
    TEWL will be measured at 3 timepoints throughout the study.


Secondary Outcome Measures:
  • Itch - 5D pruritus scale [ Time Frame: change from baseline after 12 weeks of bleach baths ] [ Designated as safety issue: No ]
    Change in self reported itch using a validated assessment tool.

  • Skin permeability [ Time Frame: change from baseline after 12 weeks of bleach baths ] [ Designated as safety issue: No ]
    amount of fluorescent labeled molecule passage through the epithelial layer ex-vivo

  • Transepithelial electrical resistance [ Time Frame: change from baseline after 12 weeks of bleach baths ] [ Designated as safety issue: No ]
    change of epithelium membrane potential and resistance in millivolts ex-vivo

  • Tissue expression of relevant inflammatory and epidermal barrier markers [ Time Frame: change from baseline after 12 weeks of bleach baths ] [ Designated as safety issue: No ]
    Messenger ribonucleic acid (mRNA) expression of key inflammatory mediators and epidermal barrier proteins performed on the biopsy specimens

  • Skin bacterial diversity [ Time Frame: change from baseline after 12 weeks of bleach baths ] [ Designated as safety issue: No ]
    Change in diversity of bacteria present in the skin


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dilute bleach bath
Subjects will take a diluted bleach bath (0.005% Sodium hypochlorite) for 5-10 minutes twice a week for 12 weeks.
Drug: bleach bath (sodium hypochlorite)
Subjects will take diluted bleach bath (0.005% Sodium Hypochlorite) for 5-10 minutes twice a week for 12 weeks.
Other Name: Sodium hypochlorite

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 promicrobial 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996150

Contacts
Contact: Nelissa Perez-Nazario, PhD 5852734195 nelissa_pereznazario@urmc.rochester.edu
Contact: Caitlyn Eberle, BA 5852731909 caitlyn_eberle@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Contact: Nelissa Perez-Nazario, PhD    585-273-4195    nelissa_pereznazario@urmc.rochester.edu   
Contact: Jean Sauvain    5852750374    jean_sauvain@urmc.rochester.edu   
Sub-Investigator: Nelissa Perez-Nazario, PhD         
Principal Investigator: Lisa Beck, MD         
Sponsors and Collaborators
University of Rochester
National Eczema Association
Investigators
Principal Investigator: Lisa Beck, MD Department of Dermatology University of Rochester
  More Information

Publications:
Responsible Party: Lisa Beck, Professor of Medicine and Dermatology, University of Rochester
ClinicalTrials.gov Identifier: NCT01996150     History of Changes
Other Study ID Numbers: BB/URMC- 2013
Study First Received: November 12, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
atopic dermatitis
eczema
bleach bath
itch
skin barrier
staphylococcus aureus

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014