A Pilot Study to Evaluate the Use of Laser Speckle Contrast Imaging on Changes in Dermal Blood Flow Induced by Intradermal Capsaicin and Topical AITC in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI)
研究概览
简要总结
Pain is a significant issue and there is a need for better treatments for pain management. Local changes in skin blood flow can be used as an indicator of pain in the body. Capsaicin and allyl isothiocyanate (AITC) increase blood flow and cause pain. The purpose of this study is to evaluate the use of laser speckle contrast imaging (LSCI) as a tool to assess changes in skin blood flow. Researchers want to learn about the effect size and reproducibility of using LSCI to measure the blood flow response to capsaicin and AITC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms performed before randomization
- •Has a skin surface without significant skin allergies, pigmentary disorders or active dermatological conditions that may interfere with the conduct of the laser speckle contrast imaging (LSCI) assessment
排除标准
- •Has a history of clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- •Has a history of stroke, chronic seizures, epilepsy, peripheral neuropathy or other clinically significant neurological disease or cognitive impairment that are severe enough to interfere with assessment of pain (sensory) systems
研究组 & 干预措施
Laser Speckle Contrast Imaging
Participants receive topical Allyl Isothiocyanate (AITC) application and intradermal capsaicin application sequentially along with a placebo comparator (vehicle for AITC and vehicle for capsaicin) once every 2 weeks per protocol to perform laser speckle contrast imaging.
干预措施: Allyl Isothiocyanate (AITC) (Drug)
Laser Speckle Contrast Imaging
Participants receive topical Allyl Isothiocyanate (AITC) application and intradermal capsaicin application sequentially along with a placebo comparator (vehicle for AITC and vehicle for capsaicin) once every 2 weeks per protocol to perform laser speckle contrast imaging.
干预措施: Capsaicin (Drug)
Laser Speckle Contrast Imaging
Participants receive topical Allyl Isothiocyanate (AITC) application and intradermal capsaicin application sequentially along with a placebo comparator (vehicle for AITC and vehicle for capsaicin) once every 2 weeks per protocol to perform laser speckle contrast imaging.
干预措施: Vehicle for AITC (Other)
Laser Speckle Contrast Imaging
Participants receive topical Allyl Isothiocyanate (AITC) application and intradermal capsaicin application sequentially along with a placebo comparator (vehicle for AITC and vehicle for capsaicin) once every 2 weeks per protocol to perform laser speckle contrast imaging.
干预措施: Vehicle for Capsaicin (Other)
结局指标
主要结局
Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI)
时间窗: Up to approximately 60 minutes
DBF is defined as the local changes in the skin blood flow after application of study intervention. DBF will be measured via a Laser Speckle Contrast Imager. The mean DBF in the ROI will be reported.
Area Under the Curve from Time 0 to 20 Minutes (AUC0-20) of Mean DBF in the ROI
时间窗: Up to approximately 20 minutes
AUC0-20 is defined as the area under the curve from time 0-20 minutes. DBF is defined as the local changes in the skin blood flow after application of study intervention. DBF will be measured via a Laser Speckle Contrast Imager. AUC0-20 of mean DBF in ROI will be reported.
Area Under the Curve from Time 0 to 60 Minutes (AUC0-60) of Mean DBF in the ROI
时间窗: Up to approximately 60 minutes
AUC0-60 is defined as the area under the curve from time 0-60 minutes. DBF is defined as the local changes in the skin blood flow after application of study intervention. DBF will be measured via a Laser Speckle Contrast Imager. AUC0-60 of mean DBF in ROI will be reported.
次要结局
- Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean)(Baseline, Up to 60 minutes)
- Change from Baseline in the Area of DBF (Flare-1 Area)(Baseline, Up to 60 minutes)
- Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean)(Baseline, Up to 60 minutes)
- Change from Baseline in the Area of DBF (Flare-2 Area)(Baseline, Up to 60 minutes)
- Mean Change From Baseline in Pain Intensity Measured Using a Pain Numeric Rating Scale (NRS)(Baseline, Up to 60 minutes)