NCT03576053

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

June 22, 2018

Last Update Submit

July 7, 2020

Conditions

ItchThermal StimulationHistamineCowhageSerotonine

Outcome Measures

Primary Outcomes (3)

  • 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

  • Skin temperature

    Infrared skin thermometer

    5 seconds

  • 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

Study Arms (3)

Histamine+cowhage+heat

EXPERIMENTAL
Other: HistamineOther: CowhageOther: Heat stimulation

Histamine+cowhage+serotonin+pre-heating

EXPERIMENTAL
Other: HistamineOther: CowhageOther: Pre-heatingOther: Serotonin

lidocaine and saline+heat

PLACEBO COMPARATOR
Drug: LidocaineOther: Heat stimulation

Interventions

LidocaineDRUG

Lidocaine intradermal injection

lidocaine and saline+heat
HistamineOTHER

Skin Prick Test with Histamine

Histamine+cowhage+heatHistamine+cowhage+serotonin+pre-heating
CowhageOTHER

Manually skin insertion of cowhage spicules

Histamine+cowhage+heatHistamine+cowhage+serotonin+pre-heating
Heat stimulationOTHER

Short heat stimulation

Histamine+cowhage+heatlidocaine and saline+heat
Pre-heatingOTHER

Mild skin pre-heating

Histamine+cowhage+serotonin+pre-heating
SerotoninOTHER

Serotonin electrophoresis

Histamine+cowhage+serotonin+pre-heating

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9220, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

LidocaineHistamineSerotonin

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesBiogenic MonoaminesBiogenic AminesEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological FactorsTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Daniele Riccio, MSc

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Only the third sub-study is conducted in a double-blind manner.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 3, 2018

Study Start

July 1, 2018

Primary Completion

July 31, 2019

Study Completion

August 28, 2019

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)