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A Mechanistic Evaluation of the Interactions Between Thermoceptive and Pruriceptive Sensory Processing

En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576053
Enrollment
59
Registered
2018-07-03
Start date
2018-07-01
Completion date
2019-08-28
Last updated
2020-07-08

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

Conditions

Cowhage, Histamine, Itch, Serotonine, Thermal Stimulation

Brief summary

The purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. Finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.

Interventions

DRUGLidocaine

Lidocaine intradermal injection

OTHERHistamine

Skin Prick Test with Histamine

OTHERCowhage

Manually skin insertion of cowhage spicules

Short heat stimulation

OTHERPre-heating

Mild skin pre-heating

Serotonin electrophoresis

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

Only the third sub-study is conducted in a double-blind manner.

Eligibility

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

Inclusion criteria

* Healthy men and women * Age 18-60 years * Able to speak and understand English

Exclusion criteria

* Suffering from chronic disease * Pregnancy or lactation * Prior experience of adverse effects from anaesthetic, specifically Lidocaine * Drug addiction defined as the use of cannabis, opioids or other drugs - 5 - * Previous neurologic, musculoskeletal or mental illnesses * Lack of ability to cooperate * Current use of medications that may affect the trial * Active skin diseases * Active participation in other experiments currently ongoing or within the last 14 days * Tattoos on volar forearms that will interfere with local skin measurements

Design outcomes

Primary

MeasureTime frameDescription
eVAS Itch10 minutesElectronic Visual Analog Scale for itch sensation. 0-100 scale, it measures the self-estimated itch the subject experience on a scale where 0 correspond to No itch and 100 Worst itch imaginable.
Skin temperature5 secondsInfrared skin thermometer
eVAS Pain10 minutesElectronic Visual Analog Scale for pain sensation. 0-100 scale, it measures the self-estimated pain the subject experience on a scale where 0 correspond to No pain and 100 Worst pain imaginable.

Countries

Denmark

Outcome results

None listed

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