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Topical Analgesic

Vehicle Patch for Fibromyalgia

N/A
Waitlist Available
Led By Roland Staud, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hr
Awards & highlights

Summary

This trial involves applying a cream with capsaicin, a substance from chili peppers, to the skin of fibromyalgia patients. The goal is to see if their increased pain sensitivity is due to changes in their brain and spinal cord. Researchers will compare their pain response over time to understand if central mechanisms are responsible for their pain. Capsaicin has been used for various pain conditions.

Eligible Conditions
  • Fibromyalgia
  • Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hr
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hr for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression of Temporal Summation of Second Pain

Trial Design

2Treatment groups
Experimental Treatment
Group I: Vehicle PatchExperimental Treatment1 Intervention
Control patch will be the same topical solution but will not contain capsaicin. The patch will applied to the hand for 30 - 60 min. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed.
Group II: Capsaicin Patch 8% or 0.1% Capsaicin CreamExperimental Treatment1 Intervention
8% capsaicin topical patch or 0.1% capsaicin cream. The patch will applied to the hand for 30 - 60 min. The cream will be applied similarly on a 3 cm2 area of the arm. Patients will be instructed to not touch or wash their hands during the course of the study to minimize spreading of the patch to other areas of the body. Subsequently, the patch will be immediately removed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capsaicin Patch 8% or 0.1% Capsaicin Cream
2018
N/A
~60

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Who is running the clinical trial?

University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,340 Total Patients Enrolled
7 Trials studying Fibromyalgia
781 Patients Enrolled for Fibromyalgia
Roland Staud, MDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
388 Total Patients Enrolled
4 Trials studying Fibromyalgia
388 Patients Enrolled for Fibromyalgia
~8 spots leftby Sep 2025
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