Itch Clinical Trial
Official title:
En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System
NCT number | NCT03576053 |
Other study ID # | N-20180035 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | August 28, 2019 |
Verified date | July 2020 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
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 |
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