Health TrialsbyHealthPanel

Sodium in the Skin and Atopic Dermatitis

ConditionsEczemaAtopic Dermatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Older adults with no history of atopic dermatitis, mild atopic dermatitis, or severe dermatitis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: No History of AD
Group B: Mild AD
Group C: Severe AD

Trial outcomes

Primary outcomes

1

Skin sodium concentration

Skin sodium concentration will be measured via non-contrast sodium MRI

Time frame
2 years
2

Atopc dermatitis serverity

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

Secondary outcomes

1

Atopic dermatitis severity and persistence

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
2

Atopic dermatitis severity

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
3

Atopic dermatitis severity

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
4

Atopic dermatitis severity

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
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