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临床试验/NCT06444594
NCT06444594Enrolling By Invitation1 期

Transient Receptor Potential Channels in Human Skin

Penn State University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年7月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
Enrolling By Invitation
入组人数
45
试验地点
2
主要终点
Skin blood flow during slow local heating

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • 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

研究组 & 干预措施

Vehicle Gel

Placebo Comparator

Non-active topical gel

干预措施: Vehicle gel (Other)

Transient Receptor Potential (M8) Agonist

Experimental

Topical menthol gel applied once at 10%

干预措施: TRPM8 Agonist (Drug)

Transient Receptor Potential (V1) Agonist

Experimental

Topical camphor gel applied once at 0.6%

干预措施: TRPV1 Agonist (Drug)

Transient Receptor Potential (V4) Agonist

Experimental

Topical capsaicin gel applied once at 0.05%

干预措施: TRPV4 Agonist (Drug)

Transient Receptor Potential M8 V4 V1 Agonist

Experimental

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

干预措施: TRPM8, TRPV4, TRPV1 Agonists (Drug)

结局指标

主要结局

Skin blood flow during slow local heating

时间窗: 75 minutes

Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin

Somatosensory perception

时间窗: every 5 minutes for 120 minues

heat and cold perception using a visual analog scale

algometer measurement

时间窗: every 30 minutes for 120 minutes

pain pressure thresholds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lacy Alexander

Professor of Kinesiology

Penn State University

研究点 (2)

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