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

NCT04197440 | Unknown DMC

• 1 other identifier: N-20190062
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Itch

Outcome Measures

Primary Outcomes (7)

• superficial blood perfusion

  is measured by a speckle contrast imager (FLPI, Moor Instruments, England)

  change from baseline, up to 10 minutes after the first session

• Warm Detection Threshold, and Heat Pain threshold

  the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  change from baseline, up to 10 minutes after the first session

• Cold Detection Threshold and Cold Pain threshold

  the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  change from baseline, up to 10 minutes after the first session

• Pain supra-threshold heat Stimuli

  the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  change from baseline, up to 10 minutes after the first session

• Alloknesis

  is measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)

  change from baseline, up to 10 minutes after the first session

• mechanical pain threshold and sensitivity

  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

  change from baseline, up to 10 minutes after the first session

• itch rating

  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"

  change from baseline, up to 10 minutes after the first session

Secondary Outcomes (1)

• pain rating

  change from baseline, up to 10 minutes after the first session

Study Arms (2)

Bam8-22

EXPERIMENTAL

Drug: BAM8-22 2mg/ml; Drug: BAM8-22 1mg/ml; Drug: BAM8-22 0.5 mg/ml; Drug: Placebo

SPT pricks

EXPERIMENTAL

Drug: BAM8-22 with 1 SPT; Drug: BAM8-22 with 5 SPT; Drug: BAM8-22 with 25 SPT; Drug: BAM8-22 with inactivate cowhage spicules

Interventions

BAM8-22 2mg/ml DRUG

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

Bam8-22

BAM8-22 1mg/ml DRUG

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

Bam8-22

BAM8-22 0.5 mg/ml DRUG

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

Bam8-22

Placebo DRUG

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

Bam8-22

BAM8-22 with 1 SPT DRUG

20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop

SPT pricks

BAM8-22 with 5 SPT DRUG

20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop

SPT pricks

BAM8-22 with 25 SPT DRUG

20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop

SPT pricks

BAM8-22 with inactivate cowhage spicules DRUG

20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules

SPT pricks

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

bovine adrenal medulla 8-22

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giulia Erica Aliotta

CONTACT

+45 50290580; gea@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: January 15, 2020
• Primary Completion: May 15, 2020
• Study Completion: December 15, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

DK (1)