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

Not Applicable

Completed

• Conditions: Itch
• Interventions: Drug: CA and BAM8-22; Drug: CA; Drug: Vehicle and BAM8-22 application; Drug: vehicle

• Registration Number: NCT06036589
• 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 agonist

Study Timeline

• Study First Submitted: 2022-03-09
• Study Start: 2022-03-10
• Primary Completion: 2022-05-30
• Study Completion: 2022-10-30
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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
CA application + BAM8-22	CA and BAM8-22	-
CA application + BAM8-22	Vehicle and BAM8-22 application	-
CA application and vehicle	CA	-
CA application and vehicle	vehicle	-

Primary Outcome Measures

Name	Time	Method
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
hyperknesis	change from baseline, up to 10 minutes after the application	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
mechanical pain threshold	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. it will be determinate a threshold corresponding to the force of the pinprick (mN) from which participants start to feel pain
superficial blood perfusion	change from baseline, up to 10 minutes after the application	is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Cold Detection 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
mechanical pain 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
Warm Detection 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
Heat 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
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
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"

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)

Aalborg University; 🇩🇰 Aalborg, Denmark