Bleach Bath Treatment of Adults With Atopic Dermatitis

NCT01996150 | Completed

• 2 other identifiers: BB/URMC- 2013R21AR062357
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Itch - 5D pruritus scale

  change from baseline after 12 weeks of bleach baths

• Skin permeability

  change from baseline after 12 weeks of bleach baths

• Transepithelial electrical resistance

  change from baseline after 12 weeks of bleach baths

• Tissue expression of relevant inflammatory and epidermal barrier markers

  change from baseline after 12 weeks of bleach baths

• Skin bacterial diversity

  change from baseline after 12 weeks of bleach baths

Study Arms (1)

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.

Drug: bleach bath (sodium hypochlorite)

Interventions

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.

Also known as: Sodium hypochlorite

Dilute bleach bath

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Eczema Association: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (4)

• 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.

  PMID: 19403473 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.

  PMID: 22310478 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.

  PMID: 21163515 BACKGROUND

• 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.

  PMID: 37755506 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus; Staphylococcal Infections

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Lisa Beck, MD

  Department of Dermatology University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Dermatology

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)