NCT04197440

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Itch

Interventions

Type	Name	Description
DRUG	BAM8-22 2mg/ml	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	BAM8-22 1mg/ml	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	BAM8-22 0.5 mg/ml	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	Placebo	20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
DRUG	BAM8-22 with 1 SPT	20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
DRUG	BAM8-22 with 5 SPT	20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
DRUG	BAM8-22 with 25 SPT	20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
DRUG	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

Timeline

• Start date: 2020-01-15
• Primary completion: 2020-05-15
• Completion: 2020-12-15
• First posted: 2019-12-13
• Last updated: 2019-12-17

Locations

1 site across 1 country: Denmark