Transient Receptor Potential Channels

NCT06444594 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 24921
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Skin blood flow during slow local heating

  Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin

  75 minutes

• Somatosensory perception

  heat and cold perception using a visual analog scale

  every 5 minutes for 120 minues

• algometer measurement

  pain pressure thresholds

  every 30 minutes for 120 minutes

Study Arms (6)

Vehicle Gel

PLACEBO COMPARATOR

Non-active topical gel

Other: Vehicle gel

Transient Receptor Potential (M8) Agonist

EXPERIMENTAL

Topical menthol gel applied once at 10%

Drug: TRPM8 Agonist

Transient Receptor Potential (V4) Agonist

EXPERIMENTAL

Topical capsaicin gel applied once at 0.05%

Drug: TRPV4 Agonist

Transient Receptor Potential (V1) Agonist

EXPERIMENTAL

Topical camphor gel applied once at 0.6%

Drug: TRPV1 Agonist

Transient Receptor Potential M8 V4 V1 Agonist

EXPERIMENTAL

Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once

Drug: TRPM8, TRPV4, TRPV1 Agonists

no gel

NO INTERVENTION

no gel comparison

Interventions

TRPM8 Agonist DRUG

menthol gel 4-10%

Also known as: menthol

Transient Receptor Potential (M8) Agonist

TRPV1 Agonist DRUG

camphor gel 5-20%

Also known as: camphor

Transient Receptor Potential (V1) Agonist

TRPV4 Agonist DRUG

capsaicin gel 0.05-1%%

Also known as: capsaicin

Transient Receptor Potential (V4) Agonist

TRPM8, TRPV4, TRPV1 Agonists DRUG

menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)

Also known as: menthol, capsaicin, camphor

Transient Receptor Potential M8 V4 V1 Agonist

Vehicle gel OTHER

Inactive vehicle gel

Also known as: Inactive vehicle gel

Vehicle Gel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• Women will not be pregnant and/or breastfeeding.

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Noll Laboratory

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Interventions

Menthol; Camphor; Capsaicin; TRPV4 protein, human

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Camphanes; Bicyclic Monoterpenes; Bridged Bicyclo Compounds; Bridged-Ring Compounds; Norbornanes; Ketones; Polycyclic Compounds; Polyunsaturated Alkamides; Amides; Alkenes; Hydrocarbons, Acyclic; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids

Study Officials

• Lacy Alexander, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lacy Alexander, Ph.D.

CONTACT

8148671781; lma191@psu.edu

Sue K Slimak, R.N.

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 5, 2024
• Study Start: July 17, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)