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With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.To explore and validate the dose-response features of a of this new itch model based on BAM8-22.
The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bam8-22 | Experimental |
| |
| SPT pricks | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAM8-22 2mg/ml | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
|
| 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 |
| Alloknesis | is measured by using a mildy 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulia Erica Aliotta | Contact | +45 50290580 | gea@hst.aau.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Aalborg | 9000 | Denmark |
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| BAM8-22 1mg/ml | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
|
| BAM8-22 0.5 mg/ml | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
|
| Placebo | Drug | 20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
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| BAM8-22 with 1 SPT | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop |
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| BAM8-22 with 5 SPT | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop |
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| BAM8-22 with 25 SPT | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop |
|
| BAM8-22 with inactivate cowhage spicules | Drug | 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules |
|
| 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 |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C571042 | bovine adrenal medulla 8-22 |
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