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

NCT05249387 | Completed DMC

• 1 other identifier: N-20190062 5th project
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Itch

Outcome Measures

Primary Outcomes (7)

• superficial blood perfusion

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

  change from baseline, up to 10 minutes after the application

• Warm Detection Threshold, and Heat Pain threshold

  he 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 and 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

• 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

• Alloknesis

  s measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)

  change from baseline, up to 10 minutes after the application

• mechanical pain threshold and 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

• 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

Secondary Outcomes (1)

• pain rating

  change from baseline, up to 10 minutes after the application

Study Arms (2)

A-967079 Injections + BAM8-22

EXPERIMENTAL

Drug: A-967079 and BAM8-22 application; Drug: A-967079 and BAM8-22 application after 5 minutes.

A-967079 Injections and vehicle

EXPERIMENTAL

Drug: A-967079 application.; Drug: Vehicle and BAM8-22 application.

Interventions

A-967079 and BAM8-22 application DRUG

A-967079 solution (in PBS 0.5 mg/ml, 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

A-967079 Injections + BAM8-22

A-967079 and BAM8-22 application after 5 minutes. DRUG

A-967079 solution (in PBS 0.5 mg/ml, 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

A-967079 Injections + BAM8-22

A-967079 application. DRUG

A-967079 solution (in PBS 0.5 mg/ml, subcutaneous injection of 0.1ml) will be applied to a previously determined area on the volar forearm

A-967079 Injections and vehicle

Vehicle and BAM8-22 application. DRUG

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

A-967079 Injections and vehicle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Giulia Erica Aliotta

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

A 967079

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD fellow

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: February 11, 2022
• Primary Completion: May 30, 2022
• Study Completion: October 30, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

DK (1)