Studies of Skin Microbes in Healthy People and in People With Skin Conditions
NCT00605878
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT06998446
The goal of this observational study is to understand factors associated with skin sodium storage in healthy adults and people with atopic dermatitis ages 50 and above.
The study is designed to test whether diet and skin barrier function are associated with skin sodium concentration and whether skin sodium concentration is linked to atopic dermatitis and immune profiles over time.
Participants will be asked to complete questionnaires, provide bio samples, and undergo non-contrast sodium MRI at 2-3 time points over 3-24 months.
Interested in participating?
Request Info50 year and older
All sexes
Observational
San Francisco VA Medical Center, San Francisco, California, United States
The central hypothesis of this proposal is that excess dietary sodium (consumed primarily as salt) is concentrated in the skin as a physiologic response to poor barrier function, and that high levels of skin sodium worsen atopic dermatitis.
The study will recruit 90 individuals (30 healthy participants, 30 with mild atopic dermatitis and 30 with severe atopic dermatitis) and follow them to identify factors associated with skin sodium storage. Diet will be evaluated using food frequency questionnaires and urine biomarkers, skin sodium concentration will be measured using a non-invasive sodium MRI technique, and atopic dermatitis activity and severity will be measured using multiple patient-reported outcomes and clinician scores. Participants without atopic dermatitis will be asked to visit the research site 4 times over 3 months. Participants with atopic dermatitis will be additionally asked to complete monthly severity scores for up to 24 months total and to visit the research site an additional 2 times when their disease severity changes.
The first specific aim will evaluate the association between dietary sodium intake and skin barrier function on skin sodium concentration. The primary analysis will use regression models to determine the association between dietary sodium intake and skin sodium concentration across 2-3 time points. The association with skin barrier function will also be evaluated.
The second specific aim will evaluate the extent to which skin sodium is associated with atopic dermatitis severity and persistence. The analysis will use regression models to determine the association between skin sodium and atopic dermatitis prevalence and severity. It will also examine immune profiles associated with skin sodium.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(Patients on dupilumab will not be excluded if they have been on dupilumab for at least two months and still meet the criteria for severe disease.)
Time frame: 2 years
Skin sodium concentration will be measured via non-contrast sodium MRI
Time frame: 2 years
Atopic dermatitis severity will be measured via the eczema area severity index (EASI). The score range is 0-72 and higher scores indicate more severe atopic dermatitis.
Time frame: 2 years
Atopic dermatitis severity and persistence will be tracked via assessments at clinic visits and via virtual monthly assessments using the Patient Oriented Eczema Measure (POEM). The POEM score ranges from 0-28 and higher scores indicate more severe atopic dematitis.
Time frame: 2 years
Atopic dermatitis-associated itch will be assessed at clinic visits using the numerical rating score for itch (NRS 11). The range for the NRS is 0-10, and higher scores indicate more severe itch / worse disease.
Time frame: 2 years
Atopic dermatitis severity will be measured at participant visits using the validated Investigator's Global Assessment (vIGA). The scores range from 0-4, and higher scores indicate more severe atopic dermatitis.
Time frame: 2 years
Atopic dermatitis severity will be measured at participant visits using a Body Surface Area (BSA) estimation. The BSA ranges from 0-100 and higher scores indicate more severe disease
Time frame: 2 years
Atopic dermatitis severity will be measured at participant visits using the Recap of Atopic Eczema (RECAP) measure of long term control. Scores range from 0-28, and higher scores indicate more severe atopic dermatitis.
Time frame: 2 years
Atopic dermatitis severity will be measured at participant visits using the Dermatology Life Quality Index (DLQI). Scores range from 0-30, and higher scores indicate worse outcomes.
Contact information is provided by the study sponsor or research team.
Jie Zhu, MD
CONTACT
Katrina Abuabara, MD
CONTACT
University of California, San Francisco
Other
Acronym: SIS-AD
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.
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