Clinical trial NCT01996150: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
eczema
bleach bath
itch
skin barrier
staphylococcus aureus
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Eczema Association
First posted: 2013-11-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping
timeFrame: change from baseline after 12 weeks of bleach baths
Secondary outcomes:
measure: Itch - 5D pruritus scale
timeFrame: change from baseline after 12 weeks of bleach baths
measure: Skin permeability
timeFrame: change from baseline after 12 weeks of bleach baths
measure: Transepithelial electrical resistance
timeFrame: change from baseline after 12 weeks of bleach baths
measure: Tissue expression of relevant inflammatory and epidermal barrier markers
timeFrame: change from baseline after 12 weeks of bleach baths
measure: Skin bacterial diversity
timeFrame: change from baseline after 12 weeks of bleach baths
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: Department of Dermatology University of Rochester
name: Lisa Beck, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.