Transient Receptor Potential Channels

Early Phase 1

Not yet recruiting

• Conditions: Aging
• Interventions: Other: Vehicle gel; Drug: TRPM8 Agonist; Drug: TRPV4 Agonist; Drug: TRPV1 Agonist; Drug: TRPM8, TRPV4, TRPV1 Agonists

• Registration Number: NCT06444594
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05
• Study Start: 2024-06-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 18-85 years old.
• Women will not be pregnant and/or breastfeeding.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vehicle Gel	Vehicle gel	Non-active topical gel
Transient Receptor Potential (M8) Agonist	TRPM8 Agonist	Topical menthol gel applied once at 10%
Transient Receptor Potential (V4) Agonist	TRPV4 Agonist	Topical capsaicin gel applied once at 0.05%
Transient Receptor Potential (V1) Agonist	TRPV1 Agonist	Topical camphor gel applied once at 0.6%
Transient Receptor Potential M8 V4 V1 Agonist	TRPM8, TRPV4, TRPV1 Agonists	Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once

Primary Outcome Measures

Name	Time	Method
Skin blood flow during slow local heating	75 minutes	Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin
Somatosensory perception	every 5 minutes for 120 minues	heat and cold perception using a visual analog scale
algometer measurement	every 30 minutes for 120 minutes	pain pressure thresholds

Trial Locations

Locations (1)

Noll Laboratory; 🇺🇸 University Park, Pennsylvania, United States