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| ID | Type | Description | Link |
|---|---|---|---|
| R21AR062357 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Eczema Association | UNKNOWN |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilute bleach bath | Experimental | Subjects will take a diluted bleach bath (0.005% Sodium hypochlorite) for 5-10 minutes twice a week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleach bath (sodium hypochlorite) | Drug | Subjects will take diluted bleach bath (0.005% Sodium Hypochlorite) for 5-10 minutes twice a week for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from baseline after 12 weeks of bleach baths |
| Measure | Description | Time Frame |
|---|---|---|
| Itch - 5D pruritus scale | Change in self reported itch using a validated assessment tool. | change from baseline after 12 weeks of bleach baths |
| Skin permeability | amount of fluorescent labeled molecule passage through the epithelial layer ex-vivo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Beck, MD | Department of Dermatology University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19403473 | Background | 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. | |
| 22310478 | Background | 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. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D011537 | Pruritus |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
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| change from baseline after 12 weeks of bleach baths |
| Transepithelial electrical resistance | change of epithelium membrane potential and resistance in millivolts ex-vivo | change from baseline after 12 weeks of bleach baths |
| 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 | change from baseline after 12 weeks of bleach baths |
| Skin bacterial diversity | Change in diversity of bacteria present in the skin | change from baseline after 12 weeks of bleach baths |
| 21163515 | Background | 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. |
| 37755506 | Derived | Stolarczyk A, Perez-Nazario N, Knowlden SA, Chinchilli E, Grier A, Paller A, Gill SR, De Benedetto A, Yoshida T, Beck LA. Bleach baths enhance skin barrier, reduce itch but do not normalize skin dysbiosis in atopic dermatitis. Arch Dermatol Res. 2023 Dec;315(10):2883-2892. doi: 10.1007/s00403-023-02723-1. Epub 2023 Sep 27. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017601 |
| Oxygen Compounds |
| D017670 | Sodium Compounds |