Transient Receptor Potential Channels (TRP)

The Pennsylvania State University (PENNSTATE)

Status and phase: Enrolling; Early Phase 1

Conditions: Aging

Treatments: Other: Vehicle gel; Drug: TRPV1 Agonist; Drug: TRPM8 Agonist; Drug: TRPV4 Agonist; Drug: TRPM8, TRPV4, TRPV1 Agonists

Study type: Interventional

Funder types: Other

Identifiers

NCT06444594

24921

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

45 participants in 6 patient groups, including a placebo group

Vehicle Gel

Placebo Comparator group

Description:

Non-active topical gel

Treatment:

Other: Vehicle gel

Transient Receptor Potential (M8) Agonist

Experimental group

Description:

Topical menthol gel applied once at 10%

Treatment:

Drug: TRPM8 Agonist

Transient Receptor Potential (V4) Agonist

Experimental group

Description:

Topical capsaicin gel applied once at 0.05%

Treatment:

Drug: TRPV4 Agonist

Transient Receptor Potential (V1) Agonist

Experimental group

Description:

Topical camphor gel applied once at 0.6%

Treatment:

Drug: TRPV1 Agonist

Transient Receptor Potential M8 V4 V1 Agonist

Experimental group

Description:

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

Treatment:

Drug: TRPM8, TRPV4, TRPV1 Agonists

no gel

No Intervention group

Description:

no gel comparison