Bleach Bath Treatment of Adults With Atopic Dermatitis
|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|
- 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.
- 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
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
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:
- 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.
- Bleach baths will improve validated measures of pruritus (itch).
- Bleach baths will diminish the local T-helper 2 (Th2) immune response measured from skin biopsy samples.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996150
|Contact: Nelissa Perez-Nazario, PhDfirstname.lastname@example.org|
|Contact: Caitlyn Eberle, BAemail@example.com|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Nelissa Perez-Nazario, PhD 585-273-4195 firstname.lastname@example.org|
|Contact: Jean Sauvain 5852750374 email@example.com|
|Sub-Investigator: Nelissa Perez-Nazario, PhD|
|Principal Investigator: Lisa Beck, MD|
|Principal Investigator:||Lisa Beck, MD||Department of Dermatology University of Rochester|