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

NCT ID: NCT03576053

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-08-28

Brief Summary

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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.

Detailed Description

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Conditions

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Itch Thermal Stimulation Histamine Cowhage Serotonine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Only the third sub-study is conducted in a double-blind manner.

Study Groups

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Histamine+cowhage+heat

Group Type EXPERIMENTAL

Histamine

Intervention Type OTHER

Skin Prick Test with Histamine

Cowhage

Intervention Type OTHER

Manually skin insertion of cowhage spicules

Heat stimulation

Intervention Type OTHER

Short heat stimulation

Histamine+cowhage+serotonin+pre-heating

Group Type EXPERIMENTAL

Histamine

Intervention Type OTHER

Skin Prick Test with Histamine

Cowhage

Intervention Type OTHER

Manually skin insertion of cowhage spicules

Pre-heating

Intervention Type OTHER

Mild skin pre-heating

Serotonin

Intervention Type OTHER

Serotonin electrophoresis

lidocaine and saline+heat

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine intradermal injection

Heat stimulation

Intervention Type OTHER

Short heat stimulation

Interventions

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Lidocaine

Lidocaine intradermal injection

Intervention Type DRUG

Histamine

Skin Prick Test with Histamine

Intervention Type OTHER

Cowhage

Manually skin insertion of cowhage spicules

Intervention Type OTHER

Heat stimulation

Short heat stimulation

Intervention Type OTHER

Pre-heating

Mild skin pre-heating

Intervention Type OTHER

Serotonin

Serotonin electrophoresis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Daniele Riccio

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniele Riccio, MSc

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Aalborg University

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20180035

Identifier Type: -

Identifier Source: org_study_id

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