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

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

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

Study Overview

• Status: Completed
• Conditions: Itch
• Intervention / Treatment: Drug: BAM8-22; Drug: Histamine; Drug: Cowhage (Mucuna Pruriens); Drug: Doxepin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: doxepin; 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; Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); Drug: Histamine; histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); Drug: Cowhage (Mucuna Pruriens); cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); Drug: Doxepin; Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm
Experimental: itch; 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; Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); Drug: Histamine; histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin); Drug: Cowhage (Mucuna Pruriens); cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain rating	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"	change from baseline, up to 10 minutes after the first session

Collaborators and Investigators

• Sponsor: Aalborg University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Antidepressive Agents, Tricyclic; Sleep Aids, Pharmaceutical; Histamine Antagonists; Histamine Agents; Histamine Agonists; Doxepin; Histamine
• Other Study ID Numbers: N-20190062 2nd project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No