Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Measuring Alloknesis
研究概览
简要总结
This third sub-project aims to evaluate the interaction between the TRPM8 receptor and pruritus by studying the anti-pruritic effect of TPRM8-agonist L-menthol on histaminergic and non-histaminergic itch induced using three different pruritogens: histamine, cowhage and papain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids or other addictive drugs
- •Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids.
- •Skin diseases
- •Moles, scars or tattoos in the area to be treated or tested.
- •Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
结局指标
主要结局
Measuring Alloknesis
时间窗: 15 minutes
Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force).
Measuring itch intensity by computerized Visual Analog Scale Scoring
时间窗: For 15 minutes
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable
Measuring pain intensity by computerized Visual Analog Scale Scoring
时间窗: For 15 minutes
We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Superficial blood perfusion measurement
时间窗: After 15 minutes
Superficial blood perfusion is measured by a Speckle contrast imager
次要结局
- Measurement of Heat Pain Thresholds (HPT)(15 minutes)
- Measurement of Mechanical Pain Sensitivity (MPS)(15 minutes)
- Touch Pleasantness (TP)(15 minutes)
- Measurement of Cold Detection Thresholds (CDT)(15 minutes)
- Measurement of Cold PainThresholds (CPT)(15 minutes)
- Measurement of Pain to Supra-threshold Heat Stimuli(15 minutes)
- Measurement of Warm Detection Thresholds (WDT)(15 minutes)
- Measurement of Mechanical Pain Thresholds (MPT)(15 minutes)
研究者
Silvia Lo Vecchio
PhD, Assistant Professor
Aalborg University