Clinical trial NCT06036589: Characterization of Bovine Adrenal Medulla as a 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: COMPLETED
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 25
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 evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22

Detailed description: With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a TRPA1 agonist

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