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The study aims to characterize the vascular response upon topical application of cinnamaldehyde, allyl isothiocyanate and capsaicin on feet skin in healthy volunteers. The vascular response will be characterized in terms of response over time, dose-response, inter-foot and inter-period reproducibility.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinnamaldehyde | Other | A 10% and 30% cinnamaldehyde solution is topically applied on foot skin. | ||
| Allyl isothiocyanate (AITC) | Other | A 15% and up to 30% AITC solution is topically applied on foot skin. | ||
| Capsaicin | Other | A 1.5% and 5% capsaicin solution is topically applied on foot skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Blood Flow response (PU) | The DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the foot, assessed with LSCI, within the area of application, expressed in arbitrary perfusion units (PU). | Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application. |
| Flare area (mm²) | The flare area of the DBF response prior to and at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet, assessed with LSCI. | Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) pain score | The Numeric Rating Scale (NRS)-11 pain score at each point in time after topical application of cinnamaldehyde, AITC and capsaicin on the feet. | Up until 60 minutes after cinnamaldehyde and AITC application; and up until 90 minutes after capsaicin application. |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy male and female volunteers aged 18 to 45 years (inclusive)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heleen Marynissen | Contact | +3216347014 | heleen.marynissen@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Pharmacology | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| C012843 | cinnamaldehyde |
| C004471 | allyl isothiocyanate |
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| 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 |