Characterization of Bovine Adrenal Medulla as a New Surrogate Model of Non-histaminergic Itch

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

With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22

Study Overview

• Status: Completed
• Conditions: Itch
• Intervention / Treatment: Drug: Vehicle and BAM8-22 application.; Drug: A-967079 and BAM8-22 application; Drug: A-967079 and BAM8-22 application after 5 minutes.; Drug: A-967079 application.

Detailed Description

With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a TRPA1 antagonist (A-967079)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Giulia Erica Aliotta

Participation Criteria

Eligibility Criteria

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

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: A-967079 Injections + BAM8-22	Drug: A-967079 and BAM8-22 application; A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml) and 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; Drug: A-967079 and BAM8-22 application after 5 minutes.; A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml). BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied 5 minutes after to a previously determined area on the volar forearm using inactivate cowhage spicules
Experimental: A-967079 Injections and vehicle	Drug: Vehicle and BAM8-22 application.; Vehicle (in PBS, subcutaneous injection of 0.1ml) and 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; Drug: A-967079 application.; A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml) will be applied to a previously determined area on the volar forearm

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 application
Warm Detection Threshold, and Heat Pain threshold	he 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 application
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 application
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 application
Alloknesis	s 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 application
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 application
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 application

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 application

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N-20190062 5th project

Drug and device information, study documents

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