Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch

Itch Clinical Trial

Official title:

Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04197440
• Other study ID #: N-20190062
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2019
• Source: Aalborg University
• Contact: Giulia Erica Aliotta
• Phone: +45 50290580
• Email: gea[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Itch

Intervention

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
• 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
• 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
• Placebo
20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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