Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Alloknesis
研究概览
简要总结
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.
详细描述
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.To explore and validate the dose-response features of a of this new itch model based on BAM8-22.
The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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 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.)
- •Moles, wounds, scars or tattoos in the area to be treated or tested
- •Lack of ability to cooperate •
- •Current use of medications that may affect the trial such as antihistamines and pain killers.
- •Skin diseases
- •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)
研究组 & 干预措施
Bam8-22
干预措施: BAM8-22 2mg/ml (Drug)
Bam8-22
干预措施: BAM8-22 1mg/ml (Drug)
Bam8-22
干预措施: BAM8-22 0.5 mg/ml (Drug)
Bam8-22
干预措施: Placebo (Drug)
SPT pricks
干预措施: BAM8-22 with 1 SPT (Drug)
SPT pricks
干预措施: BAM8-22 with 5 SPT (Drug)
SPT pricks
干预措施: BAM8-22 with 25 SPT (Drug)
SPT pricks
干预措施: BAM8-22 with inactivate cowhage spicules (Drug)
结局指标
主要结局
Alloknesis
时间窗: change from baseline, up to 10 minutes after the first session
is measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)
superficial blood perfusion
时间窗: change from baseline, up to 10 minutes after the first session
is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Warm Detection Threshold, and Heat Pain threshold
时间窗: change from baseline, up to 10 minutes after the first session
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain supra-threshold heat Stimuli
时间窗: change from baseline, up to 10 minutes after the first session
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
mechanical pain threshold and sensitivity
时间窗: change from baseline, up to 10 minutes after the first session
is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications
Cold Detection Threshold and Cold Pain threshold
时间窗: change from baseline, up to 10 minutes after the first session
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
itch rating
时间窗: change from baseline, up to 10 minutes after the first session
the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"
次要结局
- pain rating(change from baseline, up to 10 minutes after the first session)
研究者
Giulia Erica Aliotta
PhD fellow
Aalborg University