Evaluation of the Effect of Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Non-histaminergic Itch Induced by Cowhage.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Measuring Hyperknesis
研究概览
简要总结
With this experiment, we want to use to investigate whether repeated application of EMLA cream as a tool to modulate non-histaminergic itching, which is produced using small needles from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form of itch) and we want to compare the effect of short (1 hour) and prolonged (3 hours) application of EMLA. The sub-project takes place in 3 sessions over a period of 3 consecutive days (24 hours apart). All sessions will be identical.
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 drugs
- •Previous or current neurologic, musculoskeletal 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 antihistamine medications or pain killers.
- •Skin diseases
- •Hypersensitivity to papaya and mango fruit, cashew nuts and 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)
- •Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.
研究组 & 干预措施
Study group
干预措施: Cowhage (Other)
Study group
干预措施: Emla 1 hour (Drug)
Study group
干预措施: EMLA 3 hours (Drug)
Study group
干预措施: Vehicle cream for 1 hour (Other)
Study group
干预措施: Vehicle cream for 3 hours (Other)
结局指标
主要结局
Measuring Hyperknesis
时间窗: 10 min after cowhage application
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measuring itch intensity by computerized Visual Analog Scale Scoring
时间窗: For 9 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 9 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: 10 min after cowhage application
Superficial blood perfusion is measured by a Speckle contrast imager
Measuring Alloknesis
时间窗: 10 min after cowhage application
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
次要结局
- Measuring Erythema(10 min after cowhage application)
- Measuring Skin Pigmentation(10 min after cowhage application)
研究者
Silvia Lo Vecchio
PhD, Assistant Professor
Aalborg University