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

Itch Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576053
• Other study ID #: N-20180035
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: August 28, 2019

Study information

• Verified date: July 2020
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 28, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cowhage
• Histamine
• Itch
• Serotonine
• Thermal Stimulation

Intervention

Drug:
• Lidocaine
Lidocaine intradermal injection

Other:
• Histamine
Skin Prick Test with Histamine
• Cowhage
Manually skin insertion of cowhage spicules
• Heat stimulation
Short heat stimulation
• Pre-heating
Mild skin pre-heating
• Serotonin
Serotonin electrophoresis

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eVAS Itch	Electronic 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".	10 minutes
Primary	Skin temperature	Infrared skin thermometer	5 seconds
Primary	eVAS Pain	Electronic 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".	10 minutes