The Role of Pre-established Skin Inflammation on the Susceptibility to Histamine and Cowhage-induced Itch in Healthy Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Itch intensity
研究概览
简要总结
The purpose of this project is to investigate the effect of capsaicin-induced neurogenic inflammation with three different intensities on itch subsequently induced by histamine and cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation significantly increases susceptibility to itch provocations with cowhage and histamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Caucasian descent
- •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
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Moles or tattoos in the area to be irradiated
- •Exposure of the irradiated area to UV radiation (e.g., sun) 48 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
Cowhage
Cowhage is used to induce non-histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hours and Qutenza Demo Patch.
干预措施: Capsaicin 24 Hours (Drug)
Cowhage
Cowhage is used to induce non-histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hours and Qutenza Demo Patch.
干预措施: Capsaicin 1 Hour (Drug)
Cowhage
Cowhage is used to induce non-histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hours and Qutenza Demo Patch.
干预措施: Qutenza Demo Patch (Other)
Histamine
Histamine is used to induce histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch.
干预措施: Capsaicin 24 Hours (Drug)
Histamine
Histamine is used to induce histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch.
干预措施: Capsaicin 1 Hour (Drug)
Histamine
Histamine is used to induce histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch.
干预措施: Qutenza Demo Patch (Other)
结局指标
主要结局
Itch intensity
时间窗: Assessed continuously at 0-10 minutes following itch provocation
Rating of the perceived itch intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz.
次要结局
- Neurogenic inflammation(Assessed 11 minutes after itch provocation)
- Wheal size(Assessed at 10 minutes following itch provocation)
- Pain intensity(Assessed continuously at 0-10 minutes following itch provocation)
- Changes in sensitivity to touch-evoked itch(Assessed before, and at 12-15 minutes following itch provocation)
- Pain during capsaicin application(24 hours after first application of capsaicin patch)
研究者
Hjalte Holm Andersen
MSc. Med., Phd. Stud.
Aalborg University