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

NCT04588532 | Completed DMC

• 1 other identifier: N-20190062 2nd project
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

• hyperknesis (abnormal pruriceptive state)

  is measured by using a mildly 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)

doxepin

EXPERIMENTAL

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

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

itch

EXPERIMENTAL

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

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

Interventions

BAM8-22 DRUG

Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

doxepin; itch

Histamine DRUG

histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

doxepin; itch

Cowhage (Mucuna Pruriens) DRUG

cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

doxepin; itch

Doxepin DRUG

Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm

doxepin

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; Histamine; Doxepin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors; Oxepins; Ethers, Cyclic; Ethers; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

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: Principal investigator, PhD fellow

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

DK (1)