- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06444594
Transient Receptor Potential Channels (TRP)
July 24, 2026 updated by: Lacy Alexander, Penn State University
Transient Receptor Potential Channels in Human Skin
Neurovascular signaling in the skin associated with stimulation of the transient receptor potential (TRP) channels.
These channels are stimulated by both temperature and naturally occurring bioactive agents found in mint, chili peppers, garlic, etc.
The aim of the study is to examine how topically applied TRP channel agonists including menthol, capsaicin and camphor impact neurovascular responses in the skin.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Noll Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-85 years old.
- Women will not be pregnant and/or breastfeeding.
Exclusion Criteria:
- Currently pregnant or breastfeeding
- Nicotine use (e.g., smoking, chewing tobacco etc.), quantified as more than 100 cigarettes or cigars in a lifetime)
- Known skin allergies or current rash, skin disease, disorders of pigmentation
- Diabetes
- Body mass index >35kg*m-2
- Using calcium channel blockers
- Raynaud's syndrome
- Allergy or hypersensitivity to menthol, camphor, capsaicin or adhesive
- Regular use (defined as greater than once a week) of topical analgesics that contain menthol, camphor or capsaicin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Vehicle Gel
Non-active topical gel
|
Inactive vehicle gel
Other Names:
|
|
Experimental: Transient Receptor Potential (M8) Agonist
Topical menthol gel applied once at 10%
|
menthol gel 4-10%
Other Names:
|
|
Experimental: Transient Receptor Potential (V4) Agonist
Topical capsaicin gel applied once at 0.05%
|
capsaicin gel 0.05-1%%
Other Names:
|
|
Experimental: Transient Receptor Potential (V1) Agonist
Topical camphor gel applied once at 0.6%
|
camphor gel 5-20%
Other Names:
|
|
Experimental: Transient Receptor Potential M8 V4 V1 Agonist
Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once
|
menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)
Other Names:
|
|
No Intervention: no gel
no gel comparison
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin blood flow during slow local heating
Time Frame: 75 minutes
|
Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin
|
75 minutes
|
|
Somatosensory perception
Time Frame: every 5 minutes for 120 minues
|
heat and cold perception using a visual analog scale
|
every 5 minutes for 120 minues
|
|
algometer measurement
Time Frame: every 30 minutes for 120 minutes
|
pain pressure thresholds
|
every 30 minutes for 120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lacy Alexander, Ph.D., Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 24, 2024
First Submitted That Met QC Criteria
May 30, 2024
First Posted (Actual)
June 5, 2024
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 24, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Organic Chemicals
- Heterocyclic Compounds
- Fatty Acids
- Lipids
- Alkenes
- Hydrocarbons, Acyclic
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Alkaloids
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Amides
- Catechols
- Phenols
- Benzene Derivatives
- Alcohols
- Bridged-Ring Compounds
- Fatty Acids, Unsaturated
- Ketones
- Cyclohexanols
- Hexanols
- Fatty Alcohols
- Solanaceous Alkaloids
- Polyunsaturated Alkamides
- Fatty Acids, Monounsaturated
- Norbornanes
- Bridged Bicyclo Compounds
- Cyclohexane Monoterpenes
- Monoterpenes
- Camphanes
- Bicyclic Monoterpenes
- Capsaicin
- Menthol
- Camphor
- TRPV4 protein, human
Other Study ID Numbers
- 24921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.