Skin Patch Monitor for Gout

Overseen By Chen Zheng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Urate-lowering therapy

Disqualifiers: Glaucoma, Hypersensitivity, Allergies, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new skin patch, the UR+AIMS skin patch, which monitors uric acid levels and related substances in people with gout. Participants will use the patch during a meal at UCLA and continue for a week to assess its performance in real-life conditions. Those diagnosed with gout who are not currently taking urate-lowering medications or are on a stable dose may be suitable candidates. This trial aims to develop a convenient method for tracking gout-related health markers. As an unphased trial, it offers participants the chance to contribute to innovative research that could simplify gout management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that 5 participants should be on stable urate-lowering therapy without any dose changes in the last 30 days. If you are on urate-lowering therapy, you may need to continue it without changes.

What prior data suggests that the UR+AIMS skin patch is safe for monitoring uric acid and metabolites?

Research has shown that skin patch monitors, like the UR+AIMS skin patch, are generally safe for use. These patches track various health indicators, such as uric acid levels, glucose, and heart rate. This particular patch for gout has not been linked to any serious side effects.

While detailed safety data for the UR+AIMS skin patch may not be available, similar devices are usually well-tolerated. The patch is non-invasive, meaning it doesn't break the skin, which often results in fewer risks of side effects. If skin irritation occurs, it is usually mild and resolves on its own.

The UR+AIMS patch is being tested in a study that does not follow the usual clinical trial phases. This approach may result in less safety information compared to other treatments. However, because the patch is non-invasive, it is likely safe for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard gout treatments that typically involve oral medications targeting uric acid reduction, the UR+AIMS skin patch offers a unique approach by continuously monitoring uric acid and other metabolites directly through the skin. This non-invasive method allows for real-time tracking of metabolic changes, providing a more dynamic and personalized insight into a patient's condition. Researchers are excited because this could lead to more precise management of gout, potentially improving treatment outcomes and reducing the need for frequent blood tests.

What evidence suggests that the UR+AIMS skin patch is effective for monitoring gout?

Research has shown that wearable sensor patches with tiny needles, such as the UR+AIMS skin patch, can effectively monitor uric acid levels in the body. Uric acid plays a major role in gout, a condition that causes painful joint inflammation. In this trial, the UR+AIMS skin patch will track uric acid and other important health indicators like blood sugar and heart rate. Although it primarily serves as a monitoring tool, tracking uric acid levels can help manage gout symptoms. Early studies suggest that this technology could enhance gout management. ^{1 2 4 6 7}

Who Is on the Research Team?

John FitzGerald, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for 15 people with gout, some of whom haven't had recent urate-lowering therapy and others who are on a stable urate-lowering regimen. Participants will join a meal study at UCLA and then wear a skin patch that monitors uric acid levels for a week.

Inclusion Criteria

I have gout, haven't taken gout medication in the last 6 months, and my uric acid level is above 7 mg/dL.

I have gout and have been on a stable dose of urate-lowering therapy for the last 30 days.

Exclusion Criteria

I do not have conditions like acute iritis or narrow-angle glaucoma.

Known Hypersensitivity to pilocarpine hydrochloride

I have been diagnosed with pupillary block glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Initial Visit and Meal Test

Participants sign consent, complete questionnaires, and undergo a standardized meal test with blood draws at the UCLA Human Nutrition Center

1 day

1 visit (in-person)

Community 7-day Observation

Participants apply the study patch daily and record various health metrics using the study mobile device

7 days

Follow-up

Participants are monitored for safety and effectiveness after the observation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• UR+AIMS skin patch

Trial Overview The UR+AIMS skin patch, which tracks uric acid and other metabolites in patients with gout, is being tested. The study involves eating a standardized meal followed by wearing the patch to monitor changes over seven days.

How Is the Trial Designed?

Group I: Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch Experimental Treatment 1 Intervention

15 patients with gout will be invited to participate in a standardized meal at the UCLA Human Nutrition Center and a 7-day community follow up for the measurement of uric acid (and other metabolites) using our Uric Acid and Metabolite Monitor System (UR+AIMS) skin patch.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A systematic review of 68 gout trials revealed that the average number of recommended OMERACT outcome domains reported was low, with only 2.9 for acute and 2.5 for chronic gout trials, indicating a lack of adherence to established guidelines.

Key aspects such as health-related quality of life and joint damage imaging were not assessed in any of the trials, highlighting significant gaps in the evaluation of gout interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes assessed in trials of gout and accordance with OMERACT-proposed domains: a systematic literature review. Araújo, F., Cordeiro, I., Ramiro, S., et al.[2018]

Tazarotene foam 0.1% was found to cause more irritation than the vehicle foam and controls in a study with 14 participants (36%) experiencing mild and transient application-site adverse events.

The foam showed a low potential for contact sensitization, with only questionable reactions observed in three participants, indicating an acceptable safety profile for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Berg, JE., Bowman, JP., Saenz, AB.[2014]

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT06187519

UR+AIMS Gout Wearable Skin Uric Acid Monitor Study The study device will monitor the patient's UA, glucose, heart rate, blood pressure, daily steps, and sleep.

2. reporter.nih.gov reporter.nih.gov/search/mKn2AWkwnEab_rD1BUEz8Q/project-details/10642949

RePORT RePORTER - National Institutes of Health (NIH) | We will evaluate the impact of the URic AcId + metabolite Monitoring System (UR+AIMS) enhancements on gout and other metabolic clinical outcomes though a 10- ...

3. withpower.com withpower.com/trial/phase-gout-2024-2106c

Skin Patch Monitor for Gout · Info for Participants What data supports the effectiveness of the UR+AIMS skin patch treatment for gout? The research on wearable sensor patches with hydrogel microneedles shows that ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12153963/

Association Between Serum Uric Acid Levels and Skin ... Long-term follow-up studies have shown that the incidence of skin cancer is significantly higher in patients with gout compared to the general ...

5. nature.com nature.com/articles/s41392-024-01916-y

Hyperuricemia and its related diseases: mechanisms and ... The results indicated a significant association between serum uric acid levels and four health outcomes: diabetic macrovascular disease, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546606/

Gout - StatPearls - NCBI Bookshelf Gout is one of the most common causes of chronic inflammatory arthritis in the United States, characterized by monosodium urate (MSU) monohydrate crystals ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2090123217300450

Gout: An old disease in new perspective – A review Gout is a picturesque presentation of uric acid disturbance. It is the most well understood and described type of arthritis. Its epidemiology is studied.