Clinical trial NCT06809569: A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI)
timeFrame: Up to approximately 60 minutes
measure: Area Under the Curve from Time 0 to 20 Minutes (AUC0-20) of Mean DBF in the ROI
timeFrame: Up to approximately 20 minutes
measure: Area Under the Curve from Time 0 to 60 Minutes (AUC0-60) of Mean DBF in the ROI
timeFrame: Up to approximately 60 minutes
Secondary outcomes:
measure: Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean)
timeFrame: Baseline, Up to 60 minutes
measure: Change from Baseline in the Area of DBF (Flare-1 Area)
timeFrame: Baseline, Up to 60 minutes
measure: Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean)
timeFrame: Baseline, Up to 60 minutes
measure: Change from Baseline in the Area of DBF (Flare-2 Area)
timeFrame: Baseline, Up to 60 minutes
measure: Mean Change From Baseline in Pain Intensity Measured Using a Pain Numeric Rating Scale (NRS)
timeFrame: Baseline, Up to 60 minutes
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Center for Clinical Pharmacology (CCP) (Site 0001)
state: Vlaams-Brabant
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: