The Effect of Ablation of Epidermal Nerve Fibers Using 0.1% Capsaicin Cream on Spontaneous Cutaneous Burning Pain, Tactile Hyperalgesia, and Thermal Hyperalgesia: A Controlled, Masked Trial With an N of 1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Burning pain as measured by a numeric rating scale of 1-10
研究概览
简要总结
This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."
Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.
详细描述
On the first day, two areas of the skin of the subject's right abdomen will be marked and identified as sites A and B. Each day for one week the subject will be asked to grade her degree of discomfort or pain from 1 to 10 at sites marked A and B every two hours beginning at 8 a.m. and ending at 10 p.m.
Each day except for Saturday and Sunday touch-pressure sensation will be evaluated using monofilaments and heat pain sensation at sites A and B. Also evaluated will be touch pressure pain at each of these sites.
On Thursday of the first week 3 mm punch biopsies of the skin will be obtained from sites A and B and another 3 mm punch biopsy will be obtained on Thursday of the following week from sites A and B.
Following the first biopsy, the experimental creams will be applied to sites A and B. One of the experimental creams contains 0.1% Capsaisin in a bland cream. The second cream contains no Capsaisin. 0.1% Capsaisin is known to destroy the small fibers, especially pain fibers in the skin. Both the investigators applying the cream and the subject will not know which experimental cream contains the Capsaisin. The creams will be applied on Thursday of the first week but only after all testing and skin biopsies have been done. The creams will be left in place except when testing is being done, and they will not be applied after the second set of skin biopsies has been obtained.
The creams will be applied by the investigators and by the subject, care being taken so that the tube marked A is applied to the site marked A, and the tube marked B is applied to the site marked B. Between application to the two sites, investigators and the subject will use different gloves and applicators, carefully washing their hands with soap and water between and after applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 39 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pain syndrome
- •must be able to be in study for one week
排除标准
- •not able to be in study for one week
研究组 & 干预措施
Capsaicin 0.1%
Capsaicin cream 0.1% will be applied to site A or B on the subject's abdomen daily for 7 days.
干预措施: Capsaicin 0.1% (Drug)
Placebo/cream without 0.1% capsaicin
The placebo cream will be applied to site A or B on the subject's abdomen daily for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Burning pain as measured by a numeric rating scale of 1-10
时间窗: 1 week
次要结局
- Tactile hyperalgesia as measured with monofilaments A, B, C, (through I), ranging in providing forces -3, -2, -1 (through +5) In grams(1 week)
- Thermal hyperalgesia as measured by the heat as pain thermode test using CASE IVc(1 week)