Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
45 participants
INTERVENTIONAL
2024-07-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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Vehicle Gel
Non-active topical gel
Vehicle gel
Inactive vehicle gel
Transient Receptor Potential (M8) Agonist
Topical menthol gel applied once at 10%
TRPM8 Agonist
menthol gel 4-10%
Transient Receptor Potential (V4) Agonist
Topical capsaicin gel applied once at 0.05%
TRPV4 Agonist
capsaicin gel 0.05-1%%
Transient Receptor Potential (V1) Agonist
Topical camphor gel applied once at 0.6%
TRPV1 Agonist
camphor gel 5-20%
Transient Receptor Potential M8 V4 V1 Agonist
Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once
TRPM8, TRPV4, TRPV1 Agonists
menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)
no gel
no gel comparison
No interventions assigned to this group
Interventions
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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%)
Vehicle gel
Inactive vehicle gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women will not be pregnant and/or breastfeeding.
Exclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Penn State University
OTHER
Responsible Party
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Lacy Alexander
Professor of Kinesiology
Principal Investigators
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Lacy Alexander, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
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Noll Laboratory
University Park, Pennsylvania, United States
Countries
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Central Contacts
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Sue K Slimak, R.N.
Role: CONTACT
Facility Contacts
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Other Identifiers
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24921
Identifier Type: -
Identifier Source: org_study_id
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