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Characterization of Bovine Adrenal Medulla as a Model of Non-histaminergic Itch

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06036589
Enrollment
25
Registered
2023-09-14
Start date
2022-03-10
Completion date
2022-10-30
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itch

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

Interventions

DRUGCA and BAM8-22

CA (tran-cinnamaldheyde) solution (in ethanol 5%) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules

DRUGVehicle and BAM8-22 application

Vehicle (ethanol) application and BAM8-22 with inactivate cowhage spicules 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules

DRUGCA

CA (tran-cinnamaldheyde) solution (in ethanol 5%) application to a previously determined area on the volar forearm

DRUGvehicle

Vehicle (ethanol) application and inactivate cowhage spicules will be applied to a previously determined area on the volar forearm

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
itch ratingchange from baseline, up to 10 minutes after the applicationthe 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
superficial blood perfusionchange from baseline, up to 10 minutes after the applicationis measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Warm Detection Thresholdchange from baseline, up to 10 minutes after the applicationthe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Heat Pain thresholdchange from baseline, up to 10 minutes after the applicationthe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Detection Thresholdchange from baseline, up to 10 minutes after the applicationthe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Pain thresholdchange from baseline, up to 10 minutes after the applicationthe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain supra-threshold heat Stimulichange from baseline, up to 10 minutes after the applicationthe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
hyperknesischange from baseline, up to 10 minutes after the applicationmeasured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (5-30 milliNewton of force). participants will rate the itch sensation induced by stimuli with von Frey filaments on an numerical rating scale from 0 to 10
mechanical pain thresholdchange from baseline, up to 10 minutes after the applicationis 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. it will be determinate a threshold corresponding to the force of the pinprick (mN) from which participants start to feel pain
mechanical pain sensitivitychange from baseline, up to 10 minutes after the applicationis 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

Secondary

MeasureTime frameDescription
pain ratingchange from baseline, up to 10 minutes after the applicationthe 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026