Sodium Intake for Atopic Dermatitis and Psoriasis

(SIS-ISD Trial)

Not yet recruiting at 1 trial location

Overseen By Katrina Abuabara, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Diuretics, SGLT2 inhibitors, Antibiotics, Immunomodulators

Disqualifiers: MRI contraindications, Cardiac event, Liver/kidney impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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. Is there an association between skin sodium concentration and atopic dermatitis and psoriasis severity?

2. 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

Who Is on the Research Team?

Katrina Abuabara, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

I only use topical medications on my head, neck, hands, or feet.

Willing and able to undergo non-contrast MRI

I am at least 18 years old.

Exclusion Criteria

I am taking medicines that affect how my body gets rid of sodium.

I have taken antibiotics or immune system medications in the past month.

I cannot safely take sodium tablets.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Wash-in

Participants follow a low-salt diet alone to acclimate before starting the intervention

1 week

1 visit (in-person)

Treatment

Participants receive sodium chloride tablets or placebo for 5 weeks, followed by a 2-week washout, then switch to the alternate treatment for another 5 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Tablets
• Sodium chloride tablets

How Is the Trial Designed?

Group I: Sodium tablets first Experimental Treatment 2 Interventions

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.

Group II: Placebo tablets first Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

LEO Foundation

Collaborator

Trials

1

Recruited

60+