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Completed

NCT Number: NCT03576053

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

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.

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Key information

Conditions

Itch Cowhage Histamine Pathological Conditions, Signs and Symptoms Pruritus Serotonine Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Thermal Stimulation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, North Denmark, 9220, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Lidocaine intradermal injection

Histamine

Other

Skin Prick Test with Histamine

Cowhage

Other

Manually skin insertion of cowhage spicules

Heat stimulation

Other

Short heat stimulation

Pre-heating

Other

Mild skin pre-heating

Serotonin

Other

Serotonin electrophoresis

Primary outcomes

  1. eVAS Itch

    Time frame: 10 minutes

    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".

  2. Skin temperature

    Time frame: 5 seconds

    Infrared skin thermometer

  3. eVAS Pain

    Time frame: 10 minutes

    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".

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 3, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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