Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch
Not Applicable
Completed
- Conditions
- Itch
- Interventions
- Registration Number
- NCT04588532
- Lead Sponsor
- Aalborg University
- Brief Summary
With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy men and women
- 18-60 years
- Speak and understand English
Exclusion Criteria
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other drugs
- 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.)
- Moles, wounds, scars or tattoos in the area to be treated or tested
- Lack of ability to cooperate •
- Current use of medications that may affect the trial such as antihistamines and pain killers.
- Skin diseases
- Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
- Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description doxepin BAM8-22 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 doxepin Histamine 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 doxepin Cowhage (Mucuna Pruriens) 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 BAM8-22 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 itch Cowhage (Mucuna Pruriens) 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 doxepin 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 itch Histamine 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
- Primary Outcome Measures
Name Time Method 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
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
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
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
Name Time Method 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"
Trial Locations
- Locations (1)
Aalborg University
🇩🇰Aalborg, Denmark