Proof-of-concept Study for Bio-marker Assay Validation in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
研究概览
简要总结
This study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. We wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 21-
- •Skin type II or III according to the classification of Fitzpatrick (II: fair skin, always burns, sometimes tans, III: medium skin, sometimes burns, always tans).

排除标准
- •History of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain.
- •2. Consumption of analgesic drugs.
- •Hypersensitivity to sunlight.
结局指标
主要结局
Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
次要结局
未报告次要终点
研究者
Martin Angst
Professor of Anesthesia
Stanford University
