En undersøgelse af Mekanismerne Bag Nociceptiv Desensibilisering forårsaget af Topikal Capsaicin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Superficial blood perfusion measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
研究概览
简要总结
The aim of this project is to study the role of transient receptor potential (TRP-) channel V1 (TRPV1+) fibers in the development of cutaneous inflammation induced by epidermal Ultraviolet-B damage. Moreover, in this project the investigators want to evaluate if the capsaicin-desensitization action can still be induced in a skin area pretreated with topical, local anesthetic lidocaine.
详细描述
In this project the Ultraviolet- B pain model, a model using type B ultraviolet rays to induce a first-degree sunburn, will be used to induce a non-specific inflammation in the skin. This model is well-known to produce both peripheral and central hyperalgesia through sensitization of peripheral and central nociceptors. Capsaicin, the active substance in chili peppers, is currently used to treat peripheral neuropathic pain, and prolonged application of 8% capsaicin patch causes profound desensitization to painful heat stimuli and itch provocations. Therefore, the investigators would like to monitor the development of unspecific UVB-cutaneous inflammation and consequent neurogenic flare in a capsaicin pre-treated area. Moreover the investigators want to test if pre-treating the skin with lidocaine can reduce the pain associated with the capsaicin application without affecting its desensitization action.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Capsaicin+UVB group
All subjects will be treated with capsaicin, placebo + UVB, or Capsaicin+UVB.
干预措施: Capsaicin Topical (Drug)
Capsaicin+UVB group
All subjects will be treated with capsaicin, placebo + UVB, or Capsaicin+UVB.
干预措施: Ultraviolet-B (UVB) irradiation (Radiation)
Capsaicin + EMLA group
All subjects will be pre-treated with lidocain cream before capsaicin application
干预措施: Capsaicin Topical (Drug)
Capsaicin + EMLA group
All subjects will be pre-treated with lidocain cream before capsaicin application
干预措施: Histamine 1% (Other)
Capsaicin + EMLA group
All subjects will be pre-treated with lidocain cream before capsaicin application
干预措施: Lidocaine (Drug)
结局指标
主要结局
Superficial blood perfusion measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
时间窗: Changes from baseline to 7 days after intervention
Measurement of Warm Detection Thresholds and Heat thresholds by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
时间窗: Changes from baseline to 7 days after intervention
Measurement of Pain to Supra-threshold Heat Stimuli by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
时间窗: Changes from baseline to 7 days after intervention
Measurement of Mechanical Pain Thresholds and Sensitivity using a pin-prick set consisting of 8 needles each having a diameter of 0.6 mm and different force applications: 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, 50.1 and 60.0 g.
时间窗: Changes from baseline to 7 days after intervention
Trans-epidermal Water Loss (TEWL) using a 2x2 cm probe to measure the humidity gradient of the skin.
时间窗: Changes from baseline to 7 days after intervention
次要结局
- assessment of pain rating by using a visual analog scales (VAS)(Change from baseline to 24 h)
- Itch rating by using a visual analog scales (VAS)(Changes from baseline to 7 days after intervention)
研究者
Silvia Lo Vecchio
Biologist, PhD
Aalborg University