Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Bam8-22
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Drug: BAM8-22 2mg/ml
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: BAM8-22 1mg/ml
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: BAM8-22 0.5 mg/ml
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: Placebo
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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Experimental: SPT pricks
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Drug: BAM8-22 with 1 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
Drug: BAM8-22 with 5 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
Drug: BAM8-22 with 25 SPT
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
Drug: BAM8-22 with inactivate cowhage spicules
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
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Outcome Measures
Primary Outcome Measures
- superficial blood perfusion [change from baseline, up to 10 minutes after the first session]
is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
- Warm Detection Threshold, and Heat Pain threshold [change from baseline, up to 10 minutes after the first session]
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
- Cold Detection Threshold and Cold Pain threshold [change from baseline, up to 10 minutes after the first session]
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
- Pain supra-threshold heat Stimuli [change from baseline, up to 10 minutes after the first session]
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
- Alloknesis [change from baseline, up to 10 minutes after the first session]
is measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)
- mechanical pain threshold and sensitivity [change from baseline, up to 10 minutes after the first session]
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
- itch rating [change from baseline, up to 10 minutes after the first session]
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"
Secondary Outcome Measures
- pain rating [change from baseline, up to 10 minutes after the first session]
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"
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy men and women
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18-60 years
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Speak and understand English
Exclusion Criteria:
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Pregnancy or lactation
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Drug addiction defined as any use of cannabis, opioids or other drugs
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Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
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Moles, wounds, scars or tattoos in the area to be treated or tested
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Lack of ability to cooperate •
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Current use of medications that may affect the trial such as antihistamines and pain killers.
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Skin diseases
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Consumption of alcohol or painkillers 24 hours before the study days and between these
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Acute or chronic pain •
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Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Aalborg University | Aalborg | Denmark | 9000 |
Sponsors and Collaborators
- Aalborg University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N-20190062