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

A

Aalborg University

Status

Completed

Conditions

Itch
Serotonine
Thermal Stimulation
Cowhage
Histamine

Treatments

Other: Pre-heating
Other: Heat stimulation
Drug: Lidocaine
Other: Histamine
Other: Cowhage
Other: Serotonin

Study type

Interventional

Funder types

Other

Identifiers

NCT03576053
N-20180035

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

59 participants in 3 patient groups, including a placebo group

Histamine+cowhage+heat
Experimental group
Treatment:
Other: Heat stimulation
Other: Cowhage
Other: Histamine
Histamine+cowhage+serotonin+pre-heating
Experimental group
Treatment:
Other: Pre-heating
Other: Cowhage
Other: Serotonin
Other: Histamine
lidocaine and saline+heat
Placebo Comparator group
Treatment:
Other: Heat stimulation
Drug: Lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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