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

Not Applicable

Completed

• Conditions: Itch
• Interventions: Drug: A-967079 application.; Drug: A-967079 and BAM8-22 application; Drug: Vehicle and BAM8-22 application.; Drug: A-967079 and BAM8-22 application after 5 minutes.

• Registration Number: NCT05249387
• Lead Sponsor: Aalborg University

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study Start: 2022-02-11
• Study First Posted: 2022-02-21
• Primary Completion: 2022-05-30
• Study Completion: 2022-10-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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
A-967079 Injections and vehicle	Vehicle and BAM8-22 application.	-
A-967079 Injections and vehicle	A-967079 application.	-
A-967079 Injections + BAM8-22	A-967079 and BAM8-22 application	-
A-967079 Injections + BAM8-22	A-967079 and BAM8-22 application after 5 minutes.	-

Primary Outcome Measures

Name	Time	Method
itch rating	change from baseline, up to 10 minutes after the application	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"
Pain supra-threshold heat Stimuli	change from baseline, up to 10 minutes after the application	the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Alloknesis	change from baseline, up to 10 minutes after the application	s measured by using a mildy 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 application	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
superficial blood perfusion	change from baseline, up to 10 minutes after the application	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 application	he tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Detection Threshold and Cold Pain threshold	change from baseline, up to 10 minutes after the application	the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

Secondary Outcome Measures

Name	Time	Method
pain rating	change from baseline, up to 10 minutes after the application	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)

Giulia Erica Aliotta; 🇩🇰 Aalborg, Denmark