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

Sponsor

Aalborg University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05249387

Collaborator

(none)

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Itch	Drug: A-967079 and BAM8-22 application Drug: A-967079 and BAM8-22 application after 5 minutes. Drug: A-967079 application. Drug: Vehicle and BAM8-22 application.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 11, 2022

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A-967079 Injections + BAM8-22	Drug: A-967079 and BAM8-22 application A-967079 solution (in PBS 10µM, 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 10µM, 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: A-967079 application. A-967079 solution (in PBS 10µM, subcutaneous injection of 0.1ml) will be applied to a previously determined area on the volar forearm 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

Arm

Intervention/Treatment

Experimental: A-967079 Injections + BAM8-22

Drug: A-967079 and BAM8-22 application

A-967079 solution (in PBS 10µM, 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 10µM, 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: A-967079 application.

A-967079 solution (in PBS 10µM, subcutaneous injection of 0.1ml) will be applied to a previously determined area on the volar forearm

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

Outcome Measures

Primary Outcome Measures

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
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
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

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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Giulia Erica Aliotta	Aalborg		Denmark	9000

Sponsors and Collaborators

Aalborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giulia Erica Aliotta, Principal Investigator, PhD fellow, Aalborg University

ClinicalTrials.gov Identifier:

NCT05249387

Other Study ID Numbers:

N-20190062 5th project

First Posted:

Feb 21, 2022

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 10, 2022