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Bleach Bath Treatment of Adults With Atopic Dermatitis

Assessing the Impact of Bleach Baths on Itch, Cutaneous Inflammation, Microbial Flora and Skin Barrier Function in Adult Atopic Dermatitis Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01996150
Enrollment
58
Registered
2013-11-27
Start date
2014-01-31
Completion date
2017-06-01
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, eczema, bleach bath, itch, skin barrier, staphylococcus aureus

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.

Interventions

DRUGbleach bath (sodium hypochlorite)

Subjects will take diluted bleach bath (0.005% Sodium Hypochlorite) for 5-10 minutes twice a week for 12 weeks.

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
National Eczema Association
CollaboratorUNKNOWN
University of Rochester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape strippingchange from baseline after 12 weeks of bleach bathsTEWL will be measured at 3 timepoints throughout the study.

Secondary

MeasureTime frameDescription
Tissue expression of relevant inflammatory and epidermal barrier markerschange from baseline after 12 weeks of bleach bathsMessenger ribonucleic acid (mRNA) expression of key inflammatory mediators and epidermal barrier proteins performed on the biopsy specimens
Itch - 5D pruritus scalechange from baseline after 12 weeks of bleach bathsChange in self reported itch using a validated assessment tool.
Skin permeabilitychange from baseline after 12 weeks of bleach bathsamount of fluorescent labeled molecule passage through the epithelial layer ex-vivo
Transepithelial electrical resistancechange from baseline after 12 weeks of bleach bathschange of epithelium membrane potential and resistance in millivolts ex-vivo
Skin bacterial diversitychange from baseline after 12 weeks of bleach bathsChange in diversity of bacteria present in the skin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026