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

Study Overview

• Status: Unknown
• Conditions: Itch
• Intervention / Treatment: Drug: BAM8-22 2mg/ml; Drug: BAM8-22 1mg/ml; Drug: BAM8-22 0.5 mg/ml; Drug: Placebo; Drug: BAM8-22 with 1 SPT; Drug: BAM8-22 with 5 SPT; Drug: BAM8-22 with 25 SPT; Drug: BAM8-22 with inactivate cowhage spicules

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bam8-22	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
Experimental: SPT pricks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2020
• Primary Completion (Anticipated): May 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-20190062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No