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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2020
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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