Clinical trial NCT04197440: Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
Official title: Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: superficial blood perfusion
timeFrame: change from baseline, up to 10 minutes after the first session
measure: Warm Detection Threshold, and Heat Pain threshold
timeFrame: change from baseline, up to 10 minutes after the first session
measure: Cold Detection Threshold and Cold Pain threshold
timeFrame: change from baseline, up to 10 minutes after the first session
measure: Pain supra-threshold heat Stimuli
timeFrame: change from baseline, up to 10 minutes after the first session
measure: Alloknesis
timeFrame: change from baseline, up to 10 minutes after the first session
measure: mechanical pain threshold and sensitivity
timeFrame: change from baseline, up to 10 minutes after the first session
measure: itch rating
timeFrame: change from baseline, up to 10 minutes after the first session
Secondary outcomes:
measure: pain rating
timeFrame: change from baseline, up to 10 minutes after the first session
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
References: