EczemaSIS-ADNCT06998446
Sodium in the Skin and Atopic Dermatitis
An observational study of Eczema and Atopic Dermatitis, run by University of California, San Francisco at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eczema, Atopic Dermatitis
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2025to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults with no history of atopic dermatitis, mild atopic dermatitis, or severe dermatitis.
Who may be able to join
- 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).
Who cannot join
- 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.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94115
Frank Asare-Bediako, BS, 520-304-8529, frank.asarebediako@ucsf.edu
Theodora Mauro, MD
- Recruiting
UCSF Mt Zion Campus
San Francisco, California, 94511
Jie Zhu, MD, 415-502-0433, Jie.Zhu2@ucsf.edu
About this study
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.
Read the 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.
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- Sodium, Salt
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin sodium concentration
Skin sodium concentration will be measured via non-contrast sodium MRI
Measured: 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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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
Measured: 2 years
Atopic dermatitis severity
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.
Measured: 2 years
Atopic dermatitis severity
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start12 May 2025
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Katrina Abuabara, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998446
- Sponsor's protocol ID
- 22-38309
- Other IDs
- 1R01AR082831-01
- Acronym
- SIS-AD
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie the results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium in the Skin and Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06998446
- Acronym / sponsor ID
- SIS-AD / 22-38309
- Conditions
- Eczema, Atopic Dermatitis
- Keywords
- Sodium, Salt
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults with no history of atopic dermatitis, mild atopic dermatitis, or severe dermatitis.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin sodium concentration
Time frame: 2 years
Skin sodium concentration will be measured via non-contrast sodium MRI
Atopc dermatitis serverity
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.
6 secondary outcomes
Atopic dermatitis severity and persistence
Time frame: 2 years
Atopic dermatitis severity
Time frame: 2 years
Atopic dermatitis severity
Time frame: 2 years
Atopic dermatitis severity
Time frame: 2 years
Atopic dermatitis severity
Time frame: 2 years
Atopic dermatitis severity
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie the results in a publication
Related trials for Eczema
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrina Abuabara, M.D. principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eczema and Atopic Dermatitis, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Zhu, MD (415-502-0433, Jie.Zhu2@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin sodium concentration (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.