Transient Receptor Potential Channels

Aging Clinical Trial

— TRP  

Official title:

Transient Receptor Potential Channels in Human Skin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444594
• Other study ID #: 24921
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 15, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Penn State University
• Contact: Lacy Alexander, Ph.D.
• Phone: 8148671781
• Email: lma191[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• TRPM8 Agonist
menthol gel 4-10%
• TRPV1 Agonist
camphor gel 5-20%
• TRPV4 Agonist
capsaicin gel 0.05-1%%
• TRPM8, TRPV4, TRPV1 Agonists
menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)

Other:
• Vehicle gel
Inactive vehicle gel

Locations

Country	Name	City	State
United States	Noll Laboratory	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Somatosensory perception	heat and cold perception using a visual analog scale	every 5 minutes for 120 minues
Primary	algometer measurement	pain pressure thresholds	every 30 minutes for 120 minutes