A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420)

Merck Sharp & Dohme LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Allyl Isothiocyanate (AITC)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI)

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.

Time frame: Up to approximately 60 minutes

Area Under the Curve from Time 0 to 20 Minutes (AUC0-20) of Mean DBF in the ROI

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.

Time frame: Up to approximately 20 minutes

Area Under the Curve from Time 0 to 60 Minutes (AUC0-60) of Mean DBF in the ROI

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.

Time frame: Up to approximately 60 minutes

Secondary Outcomes

Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean)

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.