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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06444594
Other study ID # 24921
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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