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

NCT ID: NCT06036589

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-10-30

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

Conditions

Itch

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

CA application + BAM8-22

Group Type: EXPERIMENTAL

CA and BAM8-22

Intervention Type: DRUG

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

Vehicle and BAM8-22 application

Intervention Type: DRUG

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

CA application and vehicle

Group Type: EXPERIMENTAL

CA

Intervention Type: DRUG

CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm

vehicle

Intervention Type: DRUG

Vehicle (ethanol) application and inactivate cowhage spicules will be applied to a previously determined area on the volar forearm

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

CA

CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm

Intervention Type: DRUG

vehicle

Vehicle (ethanol) application and inactivate cowhage spicules will be applied to a previously determined area on the volar forearm

Intervention Type: DRUG

Eligibility Criteria

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

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Giulia Erica Aliotta

Principal Investigator, PhD fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20190062 3rd project

Identifier Type: -

Identifier Source: org_study_id