15 Participants Needed

Skin Patch Monitor for Gout

JF
CZ
Overseen ByChen Zheng
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Must be taking: Urate-lowering therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

15 patients with gout \[10 patients no recent urate-lowering therapy (ULT) and 5 patients on stable urate-lowering therapy (ULT)\] 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.

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 data supports the effectiveness of the UR+AIMS skin patch treatment for gout?

The research on wearable sensor patches with hydrogel microneedles shows that such patches can effectively monitor biomarkers in interstitial fluid, which is important for managing chronic conditions. This suggests that the UR+AIMS skin patch might also be effective in monitoring and managing gout by tracking relevant biomarkers.12345

What safety information is available for skin patch monitors like the UR+AIMS skin patch?

Some people may experience skin reactions like rashes or irritation from the adhesives used in wearable health devices, including skin patches. These reactions, known as allergic contact dermatitis, are often caused by chemicals like acrylates in the adhesives.678910

How does the Skin Patch Monitor for Gout treatment differ from other treatments for gout?

The Skin Patch Monitor for Gout is unique because it uses a wearable microneedle patch to monitor uric acid levels in a minimally invasive way, allowing patients to see changes in uric acid levels with the naked eye. This approach is different from traditional blood tests and offers real-time monitoring, which can improve patient compliance and convenience.1112131415

Research Team

JF

John FitzGerald, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Uric Acid and Metabolite Monitor System (UR+AIMS) skin patchExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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]

References

The Role of Ultra-High-Frequency Ultrasound in Pyoderma Gangrenosum: New Insights in Pathophysiology and Diagnosis. [2023]
Wearable Sensor Patch with Hydrogel Microneedles for In Situ Analysis of Interstitial Fluid. [2023]
High-frequency ultrasound measurement of patch test reactions. [2019]
Evaluation of a minimally invasive system for measuring glucose area under the curve during oral glucose tolerance tests: usefulness of sweat monitoring for precise measurement. [2022]
Evaluation of a contact allergy clinic. [2019]
Allergic Contact Dermatitis to Components of Wearable Adhesive Health Devices. [2021]
Urinary excretion of tetrahydrophtalimide in fruit growers with dermal exposure to captan. [2019]
Allergic contact dermatitis from diphenylthiourea in Vulkan heat retainers. [2019]
Patch testing for drugs. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies. [2014]
Outcomes assessed in trials of gout and accordance with OMERACT-proposed domains: a systematic literature review. [2018]
An analytical comparison between point-of-care uric acid testing meters. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
A laser-engraved wearable sensor for sensitive detection of uric acid and tyrosine in sweat. [2021]
Wearable transdermal colorimetric microneedle patch for Uric acid monitoring based on peroxidase-like polypyrrole nanoparticles. [2022]
Tophaceous gout: quantitative evaluation by direct physical measurement. [2013]
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