Atopic Dermatitis (Eczema)Phase 4SIS-ISDNCT07487831
The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease
A Phase 4 study testing Sodium chloride tablets in people with Atopic Dermatitis (Eczema) and Psoriasis, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The goal of this clinical trial is to demonstrate the feasibility of a trial that examines the impact of changes in dietary sodium intake on skin sodium levels, atopic dermatitis, and psoriasis. In addition, it aims to generate preliminary data to begin to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (Eczema), Psoriasis
- What is being tested?
- Sodium chloride tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2026to 17 Mar 2028
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants ages 18 years
- Willing and able to undergo non-contrast MRI.
Who cannot join
- Contraindications to MRI (such as cardiac pacemakers, claustrophobia, non-compatible intracranial vascular clips, IUDs, or other implants)
- A cardiac event in the past 6 months
- Impaired function of the liver or kidney (glomerular filtration rate <60 mL/min)
- Medications that influence sodium excretion (e.g., diuretics or SGLT2 inhibitors)
- Antibiotic or immunomodulatory medications within the last month
- Contraindications to sodium tablets
- (Topical medications used exclusively on the head/neck or hands/feet (e.g., antifungal nail treatment, antidandruff shampoo, acne cleansers) are acceptable. Topical and systemic eczema treatments are acceptable if the participant has been on a stable dose for at least 2 months and still meets the severity entry criteria. Patients on dupilumab will not be excluded if they have been on dupilumab for at least two months and still meet the disease severity inclusion criteria.)
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
UCSF Mt Zion Campus
San Francisco, California, 94115
Alicia Hamblin, 925-549-7889, Alicia.Hamblin@ucsf.edu
Katrina Abuabara, MD, katrina.abuabara@ucsf.edu
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Alicia Hamblin, 925-549-7889, Alicia.Hamblin@ucsf.edu
Katrina Abuabara, MD, 415-514-9769, katrina.abuabara@ucsf.edu
About this study
The goal of this clinical trial is to demonstrate the feasibility of a trial that examines the impact of changes in dietary sodium intake on skin sodium levels, atopic dermatitis, and psoriasis. In addition, it aims to generate preliminary data to begin to answer the following questions:
- Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity?
- Are changes in dietary sodium are associated with changes in skin sodium concentration and atopic dermatitis and psoriasis severity?
Read more
Researchers will compare sodium tablets to a placebo (a look-alike substance that contains no drug) to specifically examine the impact of altering sodium intake.
Participants will:
- Follow a low-salt diet for the duration of the 13-week study
- Take sodium chloride tablets every day for 5 weeks followed by a placebo every day for 5 weeks after a 2-week washout period, or vice versa
- Visit the clinic up to 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI
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 a low-sodium diet can improve inflammatory skin disease severity. This study is meant to generate pilot data to complement the iDOSE trial (NCT07447063). The study will recruit 50 individuals (10 participants with atopic dermatitis, 10 with psoriasis, and up to 30 'healthy' individuals without skin disease) and measure skin sodium concentration using a non-invasive sodium MRI technique. Healthy individuals will only undergo sodium scans at Visit 1. Participants with atopic dermatitis and psoriasis will be counseled on how to follow the DASH low-sodium diet and asked to maintain the diet for the duration of the 13-week study. After a 1-week wash-in period on the diet alone, they will be asked to add daily sodium chloride tablets in a self-controlled cross-over design. Participants will be randomized in equal groups to either start with sodium tables or placebo tablets. One group will receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13. The other group will receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 6-8 then sodium tablets for weeks 8-13. Sodium consumption will be evaluated using dietary recall questionnaires and urine biomarkers and eczema and psoriasis activity and severity will be measured using validated severity scores and patient-reported outcomes.
- Conditions
- Atopic Dermatitis (Eczema), Psoriasis
- Being tested
- Sodium chloride tablets, Placebo Tablets
- Keywords
- sodium, salt, diet
- Medical subject headings
- Dermatitis, Atopic, Eczema, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride tabletsDrug
During the 5-week long sodium tablet intervention period, participants will receive five 1 g sodium chloride tablets each morning and four 1 g sodium chloride tablets each evening. Each sodium chloride tablet will contain 0.394 g or 17 mmol of sodium
Placebo TabletsOther
During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening.
| Study group | Role | What they receive |
|---|---|---|
| Sodium tablets first | Experimental | Participants will be randomized to receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13. Receives: Drug: Sodium chloride tablets; Other: Placebo Tablets |
| Placebo tablets first | Experimental | Participants will be randomized to receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then sodium tablets for weeks 9-13. Receives: Drug: Sodium chloride tablets; Other: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity of low-salt diet
Fidelity of the low-salt diet and sodium tab intervention adherence will be assessed based on sodium levels from food recall questionnaires and 24-hour urine sodium samples.
Measured: 4 months
Feasibility measured by recruitment rates and exclusion and non-participation reasons
To assess feasibility, recruitment rates will be calculated and reasons for exclusion and non-participation will be summarized using descriptive statistics.
Measured: 4 months
Retention rates
Retention rates will be calculated as the proportion of visits completed and will be compared by study arm and participant characteristics.
Measured: 4 months
Secondary outcomes (9)
Eczema severity
Eczema severity will be measured by the Eczema Area Severity Index (EASI). The score range is 0-72 and higher scores indicate more severe eczema. Change in the score after the intervention periods will be compared.
Measured: 4 months
Atopic dermatitis severity measured by POEM score
Atopic dermatitis severity will be tracked via assessments at clinic visits using the Patient Oriented Eczema Measure (POEM). The POEM score ranges from 0-28 and higher scores indicate more severe atopic dermatitis; change in the score after the intervention peroids will be compared.
Measured: 4 months
Atopic dermatitis control measured by mean RECAP score
Atopic dermatitis control 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. Change in the score after the intervention periods will be compared.
Measured: 4 months
Psoriasis severity
Psoriasis severity will be measured by the Psoriasis Area and Severity Index (PASI). The score range is 0-72 and higher scores indicate more severe psoriasis. Change in the score after the intervention periods will be compared.
Measured: 4 months
Participant-reported psoriasis severity measured by PSI score
Psoriasis severity will be tracked via assessments at clinic visits using the Psoriasis Symptom Inventory (PSI). The PSI score ranges from 0-32 and higher scores indicate more severe psoriasis. Change in the score after the interventions will be compared.
Measured: 4 months
Presence of psoriatic arthritis
Potential underlying psoriatic arthritis will be assessed using the Psoriasis Epidemiology Screening Tool (PEST). The PEST score ranges from 0-5 and a score of 3 or higher indicates potential psoriatic arthritis; presence of psoriatic arthritis after the interventions and between groups will be compared.
Measured: 4 months
Participant-reported itch score
Atopic dermatitis or psoriasis-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. Change in the score after the interventions will be compared.
Measured: 4 months
Skin-related quality of life score
Skin-related quality of life will be measured at participant visits using the Dermatology Life Quality Index (DLQI). Scores range from 0-30, and higher scores indicate worse outcomes. Change in the score after the interventions will be compared.
Measured: 4 months
Clinician-reported overall severity of eczema and psoriasis
Clinician-reported overall severity of eczema and psoriasis will be assessed using the Investigator's Global Assessment (IGA). Scores range from 0-4, and higher scores indicate worse outcomes. Change in the score after the intervention periods will be compared.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start14 Jul 2026
- Primary completion17 Mar 2028 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Eczema)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Foundation
- Responsible party
- Sponsor
- Investigators
- Katrina Abuabara, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487831
- Sponsor's protocol ID
- 22-36690
- Acronym
- SIS-ISD
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Salt Intake on Sodium in the Skin and Inflammatory Skin Disease
- ClinicalTrials.gov ID
- NCT07487831
- Acronym / sponsor ID
- SIS-ISD / 22-36690
- Conditions
- Atopic Dermatitis (Eczema), Psoriasis
- Keywords
- sodium, salt, diet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- LEO Foundation
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 17 Mar 2028 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 23 Mar 2026 (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 clinical trial is to demonstrate the feasibility of a trial that examines the impact of changes in dietary sodium intake on skin sodium levels, atopic dermatitis, and psoriasis. In addition, it aims to generate preliminary data to begin to answer the following questions:
- Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity?
- Are changes in dietary sodium are associated with changes in skin sodium concentration and atopic dermatitis and psoriasis severity?
Researchers will compare sodium tablets to a placebo (a look-alike substance that contains no drug) to specifically examine the impact of altering sodium intake.
Participants will:
- Follow a low-salt diet for the duration of the 13-week study
- Take sodium chloride tablets every day for 5 weeks followed by a placebo every day for 5 weeks after a 2-week washout period, or vice versa
- Visit the clinic up to 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI
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 a low-sodium diet can improve inflammatory skin disease severity. This study is meant to generate pilot data to complement the iDOSE trial (NCT07447063). The study will recruit 50 individuals (10 participants with atopic dermatitis, 10 with psoriasis, and up to 30 'healthy' individuals without skin disease) and measure skin sodium concentration using a non-invasive sodium MRI technique. Healthy individuals will only undergo sodium scans at Visit 1. Participants with atopic dermatitis and psoriasis will be counseled on how to follow the DASH low-sodium diet and asked to maintain the diet for the duration of the 13-week study. After a 1-week wash-in period on the diet alone, they will be asked to add daily sodium chloride tablets in a self-controlled cross-over design. Participants will be randomized in equal groups to either start with sodium tables or placebo tablets. One group will receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13. The other group will receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 6-8 then sodium tablets for weeks 8-13. Sodium consumption will be evaluated using dietary recall questionnaires and urine biomarkers and eczema and psoriasis activity and severity will be measured using validated severity scores and patient-reported outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium tablets first | Experimental | Drug: Sodium chloride tablets, Other: Placebo TabletsParticipants will be randomized to receive sodium tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then placebo tablets for weeks 9-13. |
| Placebo tablets first | Experimental | Drug: Sodium chloride tablets, Other: Placebo TabletsParticipants will be randomized to receive placebo tablets for weeks 2-6, no tablets for a washout period during weeks 7-8, then sodium tablets for weeks 9-13. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants ages 18 years
- Willing and able to undergo non-contrast MRI.
Key exclusion criteria (7 listed)
- Contraindications to MRI (such as cardiac pacemakers, claustrophobia, non-compatible intracranial vascular clips, IUDs, or other implants)
- A cardiac event in the past 6 months
- Impaired function of the liver or kidney (glomerular filtration rate <60 mL/min)
- Medications that influence sodium excretion (e.g., diuretics or SGLT2 inhibitors)
- Antibiotic or immunomodulatory medications within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chloride tabletsDuring the 5-week long sodium tablet intervention period, participants will receive five 1 g sodium chloride tablets each morning and four 1 g sodium chloride tablets each evening. Each sodium chloride tablet will contain 0.394 g or 17 mmol of sodium | Drug | Placebo tablets first, Sodium tablets first |
| Placebo TabletsDuring the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening. | Other | Placebo tablets first, Sodium tablets first |
Primary outcome
Fidelity of low-salt diet
Time frame: 4 months
Fidelity of the low-salt diet and sodium tab intervention adherence will be assessed based on sodium levels from food recall questionnaires and 24-hour urine sodium samples.
Feasibility measured by recruitment rates and exclusion and non-participation reasons
Time frame: 4 months
To assess feasibility, recruitment rates will be calculated and reasons for exclusion and non-participation will be summarized using descriptive statistics.
Retention rates
Time frame: 4 months
Retention rates will be calculated as the proportion of visits completed and will be compared by study arm and participant characteristics.
9 secondary outcomes
Eczema severity
Time frame: 4 months
Atopic dermatitis severity measured by POEM score
Time frame: 4 months
Atopic dermatitis control measured by mean RECAP score
Time frame: 4 months
Psoriasis severity
Time frame: 4 months
Participant-reported psoriasis severity measured by PSI score
Time frame: 4 months
Presence of psoriatic arthritis
Time frame: 4 months
Participant-reported itch score
Time frame: 4 months
Skin-related quality of life score
Time frame: 4 months
Clinician-reported overall severity of eczema and psoriasis
Time frame: 4 months
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 9 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie the results in a publication
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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, MD 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?
A Phase 4 study testing Sodium chloride tablets in people with Atopic Dermatitis (Eczema) and Psoriasis, 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 7 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 9 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alicia Hamblin (925-549-7889, Alicia.Hamblin@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity of low-salt diet (time frame: 4 months). The study lists 3 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 9 Sep 2026.