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Topical Capsaicin for Pain Management

Phase < 1
Waitlist Available
Led By Zachary Holcomb, MD
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
35 to 75 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assess for changes every 10 minutes after application for one hour
Awards & highlights

Study Summary

This trial tests two different capsaicin creams to see if they cause irritation or pain relief when applied to the skin.

Who is the study for?
This trial is for adults aged 35-75 with healthy, unscarred skin on their forearms. Participants must not have any skin conditions that affect absorption or sensitivity, and they can't use other topical products or have a history of substance abuse. They should be willing to follow the study protocol without washing the treated area unless necessary due to discomfort.Check my eligibility
What is being tested?
The study tests two capsaicin creams (one being a palmitated formulation) against a placebo cream to see if they cause irritation or burning when applied to the forearm. The concentration used is similar to over-the-counter products, and participants will not know which treatment they receive.See study design
What are the potential side effects?
Potential side effects include temporary burning sensation, irritation at the application site, redness, and possibly swelling. These are common reactions associated with topical capsaicin treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 35 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 10 minutes after application for one hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 10 minutes after application for one hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine any change in relative burning potential for capsaicin palmitate in comparison to non-palmitated capsaicin and to placebo.
Secondary outcome measures
Determine the presence and time course of erythema.
Determine the presence and time course of skin irritation

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Capsaicin PalmitateExperimental Treatment2 Interventions
Vehicle cream containing 0.25% capsaicin palmitate will be applied to an 8 cm2 area of skin on the subject's forearm
Group II: Non-Palmitated CapsaicinActive Control2 Interventions
Vehicle cream containing 0.10% non-palmitated capsaicin will be applied to an 8 cm2 area of skin on the subject's forearm
Group III: Vehicle CreamPlacebo Group2 Interventions
Vehicle cream placebo will be applied to an 8 cm2 area of skin on the subject's forearm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Cream
2014
Completed Phase 4
~3780
Capsaicin 0.1% Cream
2022
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
70 Previous Clinical Trials
12,663 Total Patients Enrolled
Chorda Pharma, Inc.UNKNOWN
Zachary Holcomb, MDPrincipal InvestigatorCarilion Clinic

Media Library

Capsaicin Palmitate Clinical Trial Eligibility Overview. Trial Name: NCT05649228 — Phase < 1
Pain Management Research Study Groups: Vehicle Cream, Capsaicin Palmitate, Non-Palmitated Capsaicin
Pain Management Clinical Trial 2023: Capsaicin Palmitate Highlights & Side Effects. Trial Name: NCT05649228 — Phase < 1
Capsaicin Palmitate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649228 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this endeavor seeking elderly participants above the age of seventy-five?

"This study will accept patients aged 35 to 75 years old, whereas it has two studies for minors and 28 trials for seniors."

Answered by AI

Is enrollment in this test still available to participants?

"Information on clinicaltrials.gov attests that this trial is actively recruiting individuals; the first listing was posted December 1st 2022, and has been recently modified on December 9th 2021."

Answered by AI

How many participants is this clinical research project enrolling?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical research project is actively recruiting patients from a single site. The trial was originally posted on December 1st 2022 and subsequently updated on the 9th of that same month; 42 participants are being sought for the study."

Answered by AI

Am I eligible to join this experiment?

"This clinical trial is seeking 42 individuals, aged 35 to 75 years old and suffering from chronic pain. Additional eligibility requirements include the presence of two functioning arms with unscarred skin, no eczema or hyperkeratosis on either arm, agreement not to wash their forearms during the study period without extreme discomfort, willingness to use treatments blindly and compliance with protocol-mandated activities such as faithfully answering VAS queries."

Answered by AI
~23 spots leftby Mar 2025