Characterization of Bovine Adrenal Medulla as a 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: CA and BAM8-22; Drug: Vehicle and BAM8-22 application; Drug: CA; Drug: vehicle

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 agonist

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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: CA application + BAM8-22	Drug: CA and BAM8-22; CA (tran-cinnamaldheyde) solution (in ethanol 5%) application 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: Vehicle and BAM8-22 application; Vehicle (ethanol) application 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
Experimental: CA application and vehicle	Drug: CA; CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm; Drug: vehicle; Vehicle (ethanol) application and inactivate cowhage spicules 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
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
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
Warm Detection 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
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 application
Cold Detection 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
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
hyperknesis	measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (5-30 milliNewton of force). participants will rate the itch sensation induced by stimuli with von Frey filaments on an numerical rating scale from 0 to 10	change from baseline, up to 10 minutes after the application
mechanical pain threshold	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. it will be determinate a threshold corresponding to the force of the pinprick (mN) from which participants start to feel pain	change from baseline, up to 10 minutes after the application
mechanical pain 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

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): March 10, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: N-20190062 3rd 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