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CompletedNCT03576053Updated Jul 8, 2020

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

An interventional study of Lidocaine and Histamine in Itch, Thermal Stimulation and Histamine, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Aalborg University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Itch
  • Thermal Stimulation
  • Histamine
  • Cowhage
  • Serotonine
03

In context

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Histamine+cowhage+heat

    Other: Histamine · Other: Cowhage · Other: Heat stimulation

  • Experimental
    Histamine+cowhage+serotonin+pre-heating

    Other: Histamine · Other: Cowhage · Other: Pre-heating · Other: Serotonin

  • Placebo comparator
    lidocaine and saline+heat

    Drug: Lidocaine · Other: Heat stimulation

Interventions

  • DrugLidocaine

    Lidocaine intradermal injection

  • OtherHistamine

    Skin Prick Test with Histamine

  • OtherCowhage

    Manually skin insertion of cowhage spicules

  • OtherHeat stimulation

    Short heat stimulation

  • OtherPre-heating

    Mild skin pre-heating

  • OtherSerotonin

    Serotonin electrophoresis

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 10 minutes

  2. Skin temperature

    Infrared skin thermometer

    Time frame: 5 seconds

  3. 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".

    Time frame: 10 minutes

07

Study locations

1 site
  • Aalborg University
    Aalborg, Nordjylland 9220, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03576053
Lead sponsor
Aalborg University
Responsible party
Daniele Riccio (Principal investigator, Aalborg University) — Principal investigator
First posted
Jul 3, 2018
Start date
Jul 1, 2018
Primary completion
Jul 31, 2019
Completion
Aug 28, 2019
Last update
Jul 8, 2020

Study contacts

Daniele Riccio, MSc
principal investigator · Aalborg University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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