A Phase 4 interventional study of Sodium chloride tablets and Placebo Tablets in Atopic Dermatitis (Eczema) and Psoriasis, sponsored by University of California, San Francisco. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Prevention
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:
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:
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 50 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(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.)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sodium chloride tablets · Other: Placebo Tablets
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.
Drug: Sodium chloride tablets · Other: Placebo Tablets
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
During the 5-week long placebo period, participants will receive five placebo tablets each morning and four placebo tablets each evening.
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
Plan to share: Yes — All IPD that underlie the results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
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.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.
Of 45 phase 4 interventional studies under Dermatitis, Atopic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 41. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Sodium Chloride
University of California, San Francisco →