Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch

Aalborg University

Status: Unknown

Conditions: Itch

Treatments: Drug: BAM8-22 2mg/ml; Drug: BAM8-22 with inactivate cowhage spicules; Drug: BAM8-22 with 25 SPT; Drug: BAM8-22 with 5 SPT; Drug: Placebo; Drug: BAM8-22 0.5 mg/ml; Drug: BAM8-22 1mg/ml; Drug: BAM8-22 with 1 SPT

Study type: Interventional

Funder types: Other

Identifiers

NCT04197440

N-20190062

Details and patient eligibility

About

With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.

Full description

With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.To explore and validate the dose-response features of a of this new itch model based on BAM8-22.

The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Bam8-22

Experimental group

Treatment:

Drug: BAM8-22 0.5 mg/ml

Drug: BAM8-22 1mg/ml

Drug: BAM8-22 2mg/ml

Drug: Placebo

SPT pricks

Experimental group

Treatment:

Drug: BAM8-22 with inactivate cowhage spicules

Drug: BAM8-22 with 25 SPT

Drug: BAM8-22 with 1 SPT

Drug: BAM8-22 with 5 SPT