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

• Sponsor: Aalborg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03576053
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Itch; Thermal Stimulation; Histamine; Cowhage; Serotonine	Drug: Lidocaine; Other: Histamine; Other: Cowhage; Other: Heat stimulation; Other: Pre-heating; Other: Serotonin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Only the third sub-study is conducted in a double-blind manner.
• Primary Purpose: Basic Science
• Official Title: En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Aug 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Histamine+cowhage+heat	Other: Histamine; Skin Prick Test with Histamine; Other: Cowhage; Manually skin insertion of cowhage spicules; Other: Heat stimulation; Short heat stimulation
Experimental: Histamine+cowhage+serotonin+pre-heating	Other: Histamine; Skin Prick Test with Histamine; Other: Cowhage; Manually skin insertion of cowhage spicules; Other: Pre-heating; Mild skin pre-heating; Other: Serotonin; Serotonin electrophoresis
Placebo Comparator: lidocaine and saline+heat	Drug: Lidocaine; Lidocaine intradermal injection; Other: Heat stimulation; Short heat stimulation

Outcome Measures

Primary Outcome Measures

1. eVAS Itch [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 [5 seconds]

   Infrared skin thermometer

3. eVAS Pain [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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University	Aalborg	Nordjylland	Denmark	9220

Sponsors and Collaborators

• Aalborg University

Investigators

• Principal Investigator: Daniele Riccio, MSc, Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniele Riccio, Principal investigator, Aalborg University
• ClinicalTrials.gov Identifier: NCT03576053
• Other Study ID Numbers: N-20180035
• First Posted: Jul 3, 2018
• Last Update Posted: Jul 8, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lidocaine; Serotonin; Histamine

Study Results

No Results Posted as of Jul 8, 2020