NCT06998446

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
May 2025Aug 2028

First Submitted

Initial submission to the registry

May 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2028

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

3.3 years

First QC Date

May 12, 2025

Last Update Submit

July 13, 2026

Conditions

EczemaAtopic Dermatitis

Keywords

SodiumSalt

Outcome Measures

Primary Outcomes (2)

  • Skin sodium concentration

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

    2 years

  • 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.

    2 years

Secondary Outcomes (6)

  • Atopic dermatitis severity and persistence

    2 years

  • Atopic dermatitis severity

    2 years

  • Atopic dermatitis severity

    2 years

  • Atopic dermatitis severity

    2 years

  • Atopic dermatitis severity

    2 years

  • +1 more secondary outcomes

Study Arms (3)

No History of AD

Healthy controls

Mild AD

Eczema Area Severity Index (EASI): scores \<7 will be considered mild AD

Severe AD

Eczema Area Severity Index (EASI): scores \>21 will be considered severe

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94115, United States

RECRUITING

UCSF Mt Zion Campus

San Francisco, California, 94511, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, microbiome skin swabs, and saliva will be collected during each in-person visit. After local anesthesia, one 6mm punch biopsy will be collected from patients with severe atopic dermatitis, from affected skin, for use in histopathology and/or cell culture.

MeSH Terms

Conditions

EczemaDermatitis, Atopic

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Katrina Abuabara, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhu, MD

CONTACT

415-502-0433Jie.Zhu2@ucsf.edu

Katrina Abuabara, MD

CONTACT

415-514-9769katrina.abuabara@ucsf.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 31, 2025

Study Start

May 12, 2025

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

August 30, 2028

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

All IPD that underlie the results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 1 year and ending 5 years after publication of the results
Access Criteria
Researchers interested in accessing data from the project must submit a written resource request via email to the Principal Investigator and sign a Data Use Agreement. De-identified data will be shared through a secure server.

Locations

US(2)