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

NCT06809569 | Completed Phase 1

• 2 other identifiers: 0000-420MK-0000-420
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 60 minutes

Secondary Outcomes (5)

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

  Baseline, Up to 60 minutes

• Change from Baseline in the Area of DBF (Flare-1 Area)

  Baseline, Up to 60 minutes

• Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean)

  Baseline, Up to 60 minutes

• Change from Baseline in the Area of DBF (Flare-2 Area)

  Baseline, Up to 60 minutes

• Mean Change From Baseline in Pain Intensity Measured Using a Pain Numeric Rating Scale (NRS)

  Baseline, Up to 60 minutes

Study Arms (1)

Laser Speckle Contrast Imaging

EXPERIMENTAL

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.

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

Interventions

Allyl Isothiocyanate (AITC) DRUG

Topical administration

Laser Speckle Contrast Imaging

Capsaicin DRUG

Intradermal administration

Laser Speckle Contrast Imaging

Vehicle for AITC OTHER

Topical administration

Laser Speckle Contrast Imaging

Vehicle for Capsaicin OTHER

Intradermal administration

Laser Speckle Contrast Imaging

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Center for Clinical Pharmacology (CCP) (Site 0001)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

allyl isothiocyanate; Capsaicin; 2,3,4-tri-O-acetylarabinopyranosyl isothiocyanate

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: September 25, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)