Healthy
Conditions
Brief summary
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.
Interventions
Topical administration
DRUGCapsaicin
Intradermal administration
OTHERVehicle for AITC
Topical administration
OTHERVehicle for Capsaicin
Intradermal administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Area of DBF (Flare-2 Area) | Baseline, Up to 60 minutes | Flare-2 area is defined as total area of points with perfusion values exceeding baseline mean DBF + 2 standard deviations. The change from baseline in the area of DBF (Flare-2 Area) will be reported. |
| Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean) | Baseline, Up to 60 minutes | Flare-1 mean is defined as the mean perfusion of measurement points exceeding baseline mean DBF + 1 standard deviation. The change from baseline in the mean intensity of DBF (Flare-1 Mean) will be reported. |
| Mean Change From Baseline in Pain Intensity Measured Using a Pain Numeric Rating Scale (NRS) | Baseline, Up to 60 minutes | The participant's pain intensity will be assessed on each arm utilizing a pain numeric rating scale (NRS). NRS will characterize pain on a scale of 0 to 10, with 0 being 'no pain' and 10 being the 'worst pain' imaginable. The higher score indicates worse pain intensity. The mean change from baseline in pain intensity will be reported. |
| Change from Baseline in the Area of DBF (Flare-1 Area) | Baseline, Up to 60 minutes | Flare-1 area is defined as the total area of points with perfusion values exceeding baseline mean DBF + 1 standard deviation. The change from baseline in the area of DBF (Flare-1 Area) will be reported. |
| Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean) | Baseline, Up to 60 minutes | Flare-2 mean is defined as the mean perfusion of points with perfusion values exceeding baseline mean DBF + 2 standard deviations. The change from baseline in the mean intensity of DBF (Flare-2 Mean) will be reported. |
Countries
Belgium
Outcome results
None listed