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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Allyl Isothiocyanate (AITC)

Intervention Type DRUG

Topical administration

Capsaicin

Intervention Type DRUG

Intradermal administration

Vehicle for AITC

Intervention Type OTHER

Topical administration

Vehicle for Capsaicin

Intervention Type OTHER

Intradermal administration

Interventions

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Allyl Isothiocyanate (AITC)

Topical administration

Intervention Type DRUG

Capsaicin

Intradermal administration

Intervention Type DRUG

Vehicle for AITC

Topical administration

Intervention Type OTHER

Vehicle for Capsaicin

Intradermal administration

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes