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

Not Applicable

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

• Registration Number: NCT04197440
• Lead Sponsor: Aalborg University

Brief 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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-17
• Study Start: 2020-01-15
• Primary Completion: 2020-05-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SPT pricks	BAM8-22 with 1 SPT	-
SPT pricks	BAM8-22 with 25 SPT	-
SPT pricks	BAM8-22 with inactivate cowhage spicules	-
SPT pricks	BAM8-22 with 5 SPT	-
Bam8-22	BAM8-22 2mg/ml	-
Bam8-22	BAM8-22 1mg/ml	-
Bam8-22	BAM8-22 0.5 mg/ml	-
Bam8-22	Placebo	-

Primary Outcome Measures

Name	Time	Method
Alloknesis	change from baseline, up to 10 minutes after the first session	is measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)
superficial blood perfusion	change from baseline, up to 10 minutes after the first session	is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Warm Detection Threshold, and Heat Pain threshold	change from baseline, up to 10 minutes after the first session	the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain supra-threshold heat Stimuli	change from baseline, up to 10 minutes after the first session	the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
mechanical pain threshold and sensitivity	change from baseline, up to 10 minutes after the first session	is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications
Cold Detection Threshold and Cold Pain threshold	change from baseline, up to 10 minutes after the first session	the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
itch rating	change from baseline, up to 10 minutes after the first session	the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"

Secondary Outcome Measures

Name	Time	Method
pain rating	change from baseline, up to 10 minutes after the first session	the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no pain" and 100 indicates "worst imaginable pain"

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Denmark