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With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.
With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.
The experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxepin | Experimental | Drug: Doxepin + BAM8-22 Doxepin will be applied for 1.5 hrs followed by the application of BAM8-22. 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Doxepin + Histamine Doxepin will be applied for 1.5 hrs followed by the application of Histamine. 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Doxepin + Cowhage Doxepin will be applied for 1.5 hrs followed by the application of cowhage. 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop Drug: Doxepin + Placebo Doxepin will be applied for 1.5 hrs followed by the application of placebo. 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
|
| itch | Experimental | Drug: BAM8-22 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Histamine 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Cowhage 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop Drug: Placebo 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAM8-22 | Drug | Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| superficial blood perfusion | is measured by a speckle contrast imager (FLPI, Moor Instruments, England) | change from baseline, up to 10 minutes after the first session |
| Warm Detection Threshold, and Heat Pain threshold | the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | change from baseline, up to 10 minutes after the first session |
| Cold Detection Threshold and Cold Pain threshold | the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | change from baseline, up to 10 minutes after the first session |
| Pain supra-threshold heat Stimuli | the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device | change from baseline, up to 10 minutes after the first session |
| hyperknesis (abnormal pruriceptive state) | is measured by using a mildly pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force) | change from baseline, up to 10 minutes after the first session |
| mechanical pain threshold and sensitivity | is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications | change from baseline, up to 10 minutes after the first session |
| Measure | Description | Time Frame |
|---|---|---|
| pain rating | the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no pain" and 100 indicates "worst imaginable pain" | change from baseline, up to 10 minutes after the first session |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Aalborg | 9000 | 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 |
|---|---|
| C571042 | bovine adrenal medulla 8-22 |
| D006632 | Histamine |
| D004316 | Doxepin |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Histamine | Drug | histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin) |
|
| Cowhage (Mucuna Pruriens) | Drug | cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin) |
|
| Doxepin | Drug | Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm |
|
| itch rating | the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch" | change from baseline, up to 10 minutes after the first session |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005021 |
| Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010082 | Oxepins |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |