Double-blind Trial of Mannitol Cream to Block the Effect of Capsaicin Cream
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- NRS heat score, once per minute
研究概览
简要总结
Capsaicin is a TRPV1 (transient receptor potential vanilloid 1) agonist, causing pain upon application. The investigators wish to determine whether mannitol blocks the effect of capsaicin application. As both cream bases are identical and mannitol addition is the only difference between the creams, if the mannitol cream is more effective in blocking the effect of capsaicin on the TRPV1 (transient receptor potential vanilloid 1) receptor, the investigators will have established that mannitol down-regulates or blocks the TRPV1 (transient receptor potential vanilloid 1) receptor.
详细描述
Capsaicin cream, which stimulates the TRPV1 (transient receptor potential vanilloid 1) receptor, causing a burning sensation, will be applied to both halves of the upper lip until a burning sensation with 8/10 intensity on an NRS (Visual Analog Scale) scale is experienced or five minutes have elapsed. Following this, the capsaicin cream will be wiped off and 30% mannitol in vehicle cream ( isopropyl palmitate, caprylic capric triglyceride, propylene glycol, ceteareth 20, cetearyl alcohol, glyceryl stearate, polyethylene glycol 100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexyl glycerin and phenoxy ethanol) will be applied to one half of the upper lip, and vehicle cream alone will be applied to the other half. Cream assignment will be randomized and neither the subject nor the person applying the cream will know which half upper lip has which cream. Every minute for 10 minutes, the heat sensation felt in each half upper lip will be measured, using a visual scale from 0 to 10. A repeated measures analysis of variance will compare the NRS (Visual Analog Scale) scores from the 30% mannitol cream, to the NRS (Visual Analog Scale)scores from the vehicle cream. Significance will be accepted if P less than .05.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 19 and 80 years
排除标准
- •Diet containing capsaicin (Cayenne pepper, capsicum) (spicy foods), more than once a week.
- •Meal containing capsaicin (spicy foods) within 5 days prior to the experiment.
- •Any lesion, cracking, cold sore or abrasion on the lips
- •Inability to tolerate capsaicin containing "spicy foods"
- •Wearing lipstick or lip balm on the upper lip
- •Inability to fill out an NRS pain scale
- •Use of painkilling medication, within 24 hours of the study.
- •Allergy to any of the ingredients of the creams, or to mannitol
- •History of contact or allergic dermatitis
- •Pregnant or nursing women
研究组 & 干预措施
Mannitol in vehicle cream
Once the capsaicin has been removed, .2 mL of 30% mannitol in vehicle cream will be applied to one half of the upper lip and kept there for 10 minutes.
干预措施: 30% Mannitol in vehicle cream (Drug)
Vehicle Cream
Once the capsaicin has been removed, .2 mL of vehicle cream will be applied to the other half of the upper lip and kept there for 10 minutes.
干预措施: vehicle cream (Drug)
结局指标
主要结局
NRS heat score, once per minute
时间窗: 15 minutes per subject
Every minute after capsaicin cream application, subject will indicate NRS (numerical rating scale)heat score. When the score has reached 8/10 or after five minutes, the cream will be removed. The time needed to reach 8/10 heat score and the heat score achieved, or the score at five minutes will be recorded. Following application of the test creams, NRS (Visual Analog Scale) heat scores will be recorded once per minute for each side for 10 minutes.
次要结局
- Side effects of capsaicin cream on upper lip(One hour)
研究者
Helene Bertrand
Clinical instructor Department of Family Practice
University of British Columbia