Clinical trial NCT06998446: Sodium in the Skin and Atopic Dermatitis
Official title: Sodium in the Skin and Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eczema
Atopic Dermatitis
Keywords: Sodium
Salt
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2025-05-31
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults with no history of atopic dermatitis, mild atopic dermatitis, or severe dermatitis.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ages 50 years and above
* Willing to undergo non-contrast MRI (e.g., no contraindications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips or pregnancy).

Exclusion Criteria:

* History of autoimmune disease.
* Cardiac events in the last six months.
* Impaired function of the liver or kidneys (glomerular filtration rate \<60ml/min).
* Current use of medications that influence sodium excretion (e.g. thiazide diuretics, SGLT2 inhibitors and spironolactone), and/or chemotherapy or antibiotic treatment.
* Currently receiving phototherapy or taking systemic medications for atopic dermatitis including cyclosporine, methotrexate, or other broad immunosuppressive medications.

(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.)

Primary outcomes:
measure: Skin sodium concentration
timeFrame: 2 years
measure: Atopc dermatitis serverity
timeFrame: 2 years
Secondary outcomes:
measure: Atopic dermatitis severity and persistence
timeFrame: 2 years
measure: Atopic dermatitis severity
timeFrame: 2 years
measure: Atopic dermatitis severity
timeFrame: 2 years
measure: Atopic dermatitis severity
timeFrame: 2 years
measure: Atopic dermatitis severity
timeFrame: 2 years
measure: Atopic dermatitis severity
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Mt Zion Campus
state: California
Study officials:
affiliation: University of California, San Francisco
name: Katrina Abuabara, M.D.
role: PRINCIPAL_INVESTIGATOR
References: