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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0000-420 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allyl Isothiocyanate (AITC) | Drug | Topical administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Up to 60 minutes |
| Change from Baseline in the Area of DBF (Flare-1 Area) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Pharmacology (CCP) (Site 0001) | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Capsaicin |
| Drug |
Intradermal administration |
|
| Vehicle for AITC | Other | Topical administration |
|
| Vehicle for Capsaicin | Other | Intradermal administration |
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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. |
| 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. | 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. | 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. | Baseline, Up to 60 minutes |
| ID | Term |
|---|---|
| C004471 | allyl isothiocyanate |
| D002211 | Capsaicin |
| C041942 | 2,3,4-tri-O-acetylarabinopyranosyl isothiocyanate |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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