Image

Sodium in the Skin and Atopic Dermatitis

Sodium in the Skin and Atopic Dermatitis

Recruiting
50 years and older
All
Phase N/A

Powered by AI

Overview

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.

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

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.)

Study details
    Eczema
    Atopic Dermatitis

NCT06998446

University of California, San Francisco

9 June 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.