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

NCT ID: NCT05249387

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2022-10-30

Brief Summary

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

Detailed Description

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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)

Conditions

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Itch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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A-967079 Injections + BAM8-22

Group Type EXPERIMENTAL

A-967079 and BAM8-22 application

Intervention Type 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 and BAM8-22 application after 5 minutes.

Intervention Type 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 and vehicle

Group Type EXPERIMENTAL

A-967079 application.

Intervention Type 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

Vehicle and BAM8-22 application.

Intervention Type 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

Interventions

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A-967079 and BAM8-22 application

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

Intervention Type DRUG

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

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

Intervention Type DRUG

A-967079 application.

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Giulia Erica Aliotta

Principal Investigator, PhD fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Giulia Erica Aliotta

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20190062 5th project

Identifier Type: -

Identifier Source: org_study_id

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