HealthyPhase 1NCT06809569
A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420)
A Phase 1 study testing Allyl Isothiocyanate (AITC) and Capsaicin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Allyl Isothiocyanate (AITC) and Capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Sep 2023to 15 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site
Center for Clinical Pharmacology (CCP) (Site 0001)
Leuven, Vlaams-Brabant, 3000
About this study
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
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
- Being tested
- Allyl Isothiocyanate (AITC), Capsaicin, Vehicle for AITC, Vehicle for Capsaicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allyl Isothiocyanate (AITC)Drug
Topical administration
CapsaicinDrug
Intradermal administration
Vehicle for AITCOther
Topical administration
Vehicle for CapsaicinOther
Intradermal administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Allyl Isothiocyanate (AITC); Drug: Capsaicin; Other: Vehicle for AITC; Other: Vehicle for Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 60 minutes
Secondary outcomes (5)
Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean)
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.
Measured: Baseline, Up to 60 minutes
Change from Baseline in the Area of DBF (Flare-1 Area)
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.
Measured: Baseline, Up to 60 minutes
Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean)
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.
Measured: Baseline, Up to 60 minutes
Change from Baseline in the Area of DBF (Flare-2 Area)
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.
Measured: Baseline, Up to 60 minutes
Mean Change From Baseline in Pain Intensity Measured Using a Pain Numeric Rating Scale (NRS)
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.
Measured: Baseline, Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start25 Sep 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809569
- Sponsor's protocol ID
- 0000-420
- Other IDs
- MK-0000-420
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06809569
- Acronym / sponsor ID
- 0000-420
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Speckle Contrast Imaging | Experimental | Drug: Allyl Isothiocyanate (AITC), Drug: Capsaicin, Other: Vehicle for AITC, Other: Vehicle for CapsaicinParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allyl Isothiocyanate (AITC)Topical administration | Drug | Laser Speckle Contrast Imaging |
| CapsaicinIntradermal administration | Drug | Laser Speckle Contrast Imaging |
| Vehicle for AITCTopical administration | Other | Laser Speckle Contrast Imaging |
| Vehicle for CapsaicinIntradermal administration | Other | Laser Speckle Contrast Imaging |
Primary outcome
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.
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.
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.
5 secondary outcomes
Change from Baseline in the Mean Intensity of DBF (Flare-1 Mean)
Time frame: Baseline, Up to 60 minutes
Change from Baseline in the Area of DBF (Flare-1 Area)
Time frame: Baseline, Up to 60 minutes
Change from Baseline in the Mean Intensity of DBF (Flare-2 Mean)
Time frame: Baseline, Up to 60 minutes
Change from Baseline in the Area of DBF (Flare-2 Area)
Time frame: Baseline, Up to 60 minutes
Mean Change From Baseline in Pain Intensity Measured Using a Pain Numeric Rating Scale (NRS)
Time frame: Baseline, Up to 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allyl Isothiocyanate (AITC) and Capsaicin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Dermal Blood Flow (DBF) in the Region of Interest (ROI) (time frame: Up to approximately 60 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.