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

• Sponsor: Aalborg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06036589
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 3.3

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: CA and BAM8-22; Drug: Vehicle and BAM8-22 application; Drug: CA; Drug: vehicle	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 agonist

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 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: Mar 10, 2022
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. superficial blood perfusion [change from baseline, up to 10 minutes after the application]

   is measured by a speckle contrast imager (FLPI, Moor Instruments, England)

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

1. 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	Aalborg University	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: NCT06036589
• Other Study ID Numbers: N-20190062 3rd project
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 14, 2023