University of Rochester Medical Center
Rochester, New York, 14642, United States
NCT Number: NCT01996150
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).
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Rochester, New York, 14642, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will take diluted bleach bath (0.005% Sodium Hypochlorite) for 5-10 minutes twice a week for 12 weeks.
Other names: Sodium hypochlorite
Time frame: change from baseline after 12 weeks of bleach baths
TEWL will be measured at 3 timepoints throughout the study.
Time frame: change from baseline after 12 weeks of bleach baths
Change in self reported itch using a validated assessment tool.
Time frame: change from baseline after 12 weeks of bleach baths
amount of fluorescent labeled molecule passage through the epithelial layer ex-vivo
Time frame: change from baseline after 12 weeks of bleach baths
change of epithelium membrane potential and resistance in millivolts ex-vivo
Time frame: change from baseline after 12 weeks of bleach baths
Messenger ribonucleic acid (mRNA) expression of key inflammatory mediators and epidermal barrier proteins performed on the biopsy specimens
Time frame: change from baseline after 12 weeks of bleach baths
Change in diversity of bacteria present in the skin
University of Rochester
Other
Assessing the Impact of Bleach Baths on Itch, Cutaneous Inflammation, Microbial Flora and Skin Barrier Function in Adult Atopic Dermatitis Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06238817
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Little Rock, Arkansas, United States
View Trial DetailsNCT06516783
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Lodz, Poland
View Trial DetailsNCT03745651
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial DetailsNCT03745638
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial Details