Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch

NCT ID: NCT04588532

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-06-01

Brief Summary

With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.

Detailed Description

With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.

The experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.

Conditions

Itch

Study Design

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

Study Groups

doxepin

Drug: Doxepin + BAM8-22 Doxepin will be applied for 1.5 hrs followed by the application of BAM8-22. 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop

Drug: Doxepin + Histamine Doxepin will be applied for 1.5 hrs followed by the application of Histamine. 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop

Drug: Doxepin + Cowhage Doxepin will be applied for 1.5 hrs followed by the application of cowhage. 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop

Drug: Doxepin + Placebo Doxepin will be applied for 1.5 hrs followed by the application of placebo. 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop

Group Type: EXPERIMENTAL

BAM8-22

Intervention Type: DRUG

Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Histamine

Intervention Type: DRUG

histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Cowhage (Mucuna Pruriens)

Intervention Type: DRUG

cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Doxepin

Intervention Type: DRUG

Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm

itch

Drug: BAM8-22 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop

Drug: Histamine 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop

Drug: Cowhage 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop

Drug: Placebo 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop

Group Type: EXPERIMENTAL

BAM8-22

Intervention Type: DRUG

Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Histamine

Intervention Type: DRUG

histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Cowhage (Mucuna Pruriens)

Intervention Type: DRUG

cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Interventions

BAM8-22

Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Intervention Type: DRUG

Histamine

histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Intervention Type: DRUG

Cowhage (Mucuna Pruriens)

cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Intervention Type: DRUG

Doxepin

Doxepin cream (antihistamine) will be applied in 4 areas 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 2nd project

Identifier Type: -

Identifier Source: org_study_id