Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch
Study Details
Study Description
Brief Summary
With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: doxepin 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 |
Drug: BAM8-22
Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
Drug: Histamine
histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
Drug: Cowhage (Mucuna Pruriens)
cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
Drug: Doxepin
Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm
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Experimental: itch 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 |
Drug: BAM8-22
Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
Drug: Histamine
histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
Drug: Cowhage (Mucuna Pruriens)
cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
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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
- hyperknesis (abnormal pruriceptive state) [change from baseline, up to 10 minutes after the first session]
is measured by using a mildly 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 2nd project