AgingEarly Phase 1TRPNCT06444594
Transient Receptor Potential Channels
A Early Phase 1 study testing TRPM8 Agonist, TRPV1 Agonist and TRPV4 Agonist in people with Aging, run by Penn State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- TRPM8 Agonist, TRPV1 Agonist and TRPV4 Agonist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-85 years old.
- Women will not be pregnant and/or breastfeeding.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Noll Laboratory
University Park, Pennsylvania, 16802
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- TRPM8 Agonist, TRPV1 Agonist, TRPV4 Agonist, TRPM8, TRPV4, TRPV1 Agonists, Vehicle gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRPM8 AgonistDrug
Also called menthol
menthol gel 4-10%
TRPV1 AgonistDrug
Also called camphor
camphor gel 5-20%
TRPV4 AgonistDrug
Also called capsaicin
capsaicin gel 0.05-1%%
TRPM8, TRPV4, TRPV1 AgonistsDrug
Also called menthol, capsaicin, camphor
menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)
Vehicle gelOther
Also called Inactive vehicle gel
Inactive vehicle gel
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Gel | Placebo comparator | Non-active topical gel Receives: Other: Vehicle gel |
| Transient Receptor Potential (M8) Agonist | Experimental | Topical menthol gel applied once at 10% Receives: Drug: TRPM8 Agonist |
| Transient Receptor Potential (V4) Agonist | Experimental | Topical capsaicin gel applied once at 0.05% Receives: Drug: TRPV4 Agonist |
| Transient Receptor Potential (V1) Agonist | Experimental | Topical camphor gel applied once at 0.6% Receives: Drug: TRPV1 Agonist |
| Transient Receptor Potential M8 V4 V1 Agonist | Experimental | Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once Receives: Drug: TRPM8, TRPV4, TRPV1 Agonists |
| no gel | No intervention | no gel comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin blood flow during slow local heating
Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin
Measured: 75 minutes
Somatosensory perception
heat and cold perception using a visual analog scale
Measured: every 5 minutes for 120 minues
algometer measurement
pain pressure thresholds
Measured: every 30 minutes for 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start17 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lacy Alexander, Penn State University
- Investigators
- Lacy Alexander, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444594
- Sponsor's protocol ID
- 24921
- Acronym
- TRP
- Status last verified
- Jul 2026
- First submitted
- 24 May 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Receptor Potential Channels in Human Skin
- ClinicalTrials.gov ID
- NCT06444594
- Acronym / sponsor ID
- TRP / 24921
- Conditions
- Aging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vehicle Gel | Placebo comparator | Other: Vehicle gelNon-active topical gel |
| Transient Receptor Potential (M8) Agonist | Experimental | Drug: TRPM8 AgonistTopical menthol gel applied once at 10% |
| Transient Receptor Potential (V4) Agonist | Experimental | Drug: TRPV4 AgonistTopical capsaicin gel applied once at 0.05% |
| Transient Receptor Potential (V1) Agonist | Experimental | Drug: TRPV1 AgonistTopical camphor gel applied once at 0.6% |
| Transient Receptor Potential M8 V4 V1 Agonist | Experimental | Drug: TRPM8, TRPV4, TRPV1 AgonistsTopical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once |
| no gel | No intervention | –no gel comparison |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-85 years old.
- Women will not be pregnant and/or breastfeeding.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRPM8 AgonistAlso: mentholmenthol gel 4-10% | Drug | Transient Receptor Potential (M8) Agonist |
| TRPV1 AgonistAlso: camphorcamphor gel 5-20% | Drug | Transient Receptor Potential (V1) Agonist |
| TRPV4 AgonistAlso: capsaicincapsaicin gel 0.05-1%% | Drug | Transient Receptor Potential (V4) Agonist |
| TRPM8, TRPV4, TRPV1 AgonistsAlso: menthol, capsaicin, camphormenthol (4-10%), capsaicin (0.05-1%), camphor (5-20%) | Drug | Transient Receptor Potential M8 V4 V1 Agonist |
| Vehicle gelAlso: Inactive vehicle gelInactive vehicle gel | Other | Vehicle Gel |
Primary outcome
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
Somatosensory perception
Time frame: every 5 minutes for 120 minues
heat and cold perception using a visual analog scale
algometer measurement
Time frame: every 30 minutes for 120 minutes
pain pressure thresholds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lacy Alexander, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TRPM8 Agonist, TRPV1 Agonist and TRPV4 Agonist in people with Aging, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin blood flow during slow local heating (time frame: 75 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.