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NCT Number: 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)

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Center for Clinical Pharmacology (CCP) (Site 0001)

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allyl Isothiocyanate (AITC)

Drug

Topical administration

Capsaicin

Drug

Intradermal administration

Vehicle for AITC

Other

Topical administration

Vehicle for Capsaicin

Other

Intradermal administration

Primary outcomes

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

    Time frame: Up to approximately 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. The mean DBF in the ROI will be reported.

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

    Time frame: Up to approximately 20 minutes

    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.

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

    Time frame: Up to approximately 60 minutes

    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.

Secondary outcomes

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

    Time frame: Baseline, Up to 60 minutes

    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.

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

    Time frame: Baseline, Up to 60 minutes

    Flare-1 area is defined as the total area of points with perfusion values exceeding baseline mean DBF + 1 standard deviation. The change from baseline in the area of DBF (Flare-1 Area) will be reported.

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

    Time frame: Baseline, Up to 60 minutes

    Flare-2 mean is defined as the mean perfusion of points with perfusion values exceeding baseline mean DBF + 2 standard deviations. The change from baseline in the mean intensity of DBF (Flare-2 Mean) will be reported.

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

    Time frame: Baseline, Up to 60 minutes

    Flare-2 area is defined as total area of points with perfusion values exceeding baseline mean DBF + 2 standard deviations. The change from baseline in the area of DBF (Flare-2 Area) will be reported.

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

    Time frame: Baseline, Up to 60 minutes

    The participant's pain intensity will be assessed on each arm utilizing a pain numeric rating scale (NRS). NRS will characterize pain on a scale of 0 to 10, with 0 being 'no pain' and 10 being the 'worst pain' imaginable. The higher score indicates worse pain intensity. The mean change from baseline in pain intensity will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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