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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
30
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Aalborg University
Aalborg, Denmark
superficial blood perfusion
is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: change from baseline, up to 10 minutes after the first session
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"
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20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
Time frame: change from baseline, up to 10 minutes after the first session
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"
Time frame: change from baseline, up to 10 minutes after the first session