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The purpose of this project is to investigate the effect of capsaicin-induced neurogenic inflammation with three different intensities on itch subsequently induced by histamine and cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation significantly increases susceptibility to itch provocations with cowhage and histamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cowhage | Other | Cowhage is used to induce non-histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hours and Qutenza Demo Patch. |
|
| Histamine | Other | Histamine is used to induce histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin 24 Hours | Drug | Dermal patches for transdermal application of Capsaicin, applied for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Itch intensity | Rating of the perceived itch intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz. | Assessed continuously at 0-10 minutes following itch provocation |
| Measure | Description | Time Frame |
|---|---|---|
| Neurogenic inflammation | Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI) | Assessed 11 minutes after itch provocation |
| Changes in sensitivity to touch-evoked itch |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMI | Aalborg | NJ | 9220 | Denmark |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Capsaicin 1 Hour | Drug | Dermal patches for transdermal application of Capsaicin, applied for 1 hour |
|
|
| Qutenza Demo Patch | Other | Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours. |
|
|
Three von Frey filaments are applied to the test area before and after itch provocation. Subjects report three NRS scores ('0-10', 'No itch-Worst imaginable itch') for itch induced by von Frey stimulation. Change is calculated by subtracting baseline mean from post-provocation mean NRS scores.
| Assessed before, and at 12-15 minutes following itch provocation |
| Wheal size | Histamine wheal size is assessed by measuring the longest diameter of the wheal with a ruler, followed by measuring the orthogonal diameter. The mean of these diameters will represent the wheal size in diameter, reported in mm. | Assessed at 10 minutes following itch provocation |
| Pain intensity | Rating of the perceived pain intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz. | Assessed continuously at 0-10 minutes following itch provocation |
| Pain during capsaicin application | Peak and average numerical rating scale (NRS) scores ('0-10, 'no pain-worst imaginable pain') are reported by subjects for each patch. | 24 hours after first application of capsaicin patch |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |