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 (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Vehicle for AITC; Other: Vehicle for Capsaicin; Drug: Allyl Isothiocyanate (AITC); Drug: Capsaicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06809569

0000-420

MK-0000-420 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Laser Speckle Contrast Imaging

Experimental group

Description:

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.

Treatment:

Drug: Capsaicin

Drug: Allyl Isothiocyanate (AITC)

Other: Vehicle for Capsaicin

Other: Vehicle for AITC