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

Aalborg University

Status: Completed

Conditions: Itch

Treatments: Drug: Cowhage (Mucuna Pruriens); Drug: Doxepin; Drug: BAM8-22; Drug: Histamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04588532

N-20190062 2nd project

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 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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24 participants in 2 patient groups

doxepin

Experimental group

Description:

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

Treatment:

Drug: Histamine

Drug: BAM8-22

Drug: Doxepin

Drug: Cowhage (Mucuna Pruriens)

itch

Experimental group

Description:

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

Treatment:

Drug: Histamine

Drug: BAM8-22

Drug: Cowhage (Mucuna Pruriens)