Investigation of a New Human Model for Itch

Itch Clinical Trial

Official title:

Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711044
• Other study ID #: N-20200005 (third sub-project)
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 5, 2021

Study information

• Verified date: July 2021
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This third sub-project aims to evaluate the interaction between the TRPM8 receptor and pruritus by studying the anti-pruritic effect of TPRM8-agonist L-menthol on histaminergic and non-histaminergic itch induced using three different pruritogens: histamine, cowhage and papain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 5, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy men and women

• 18-60 years

• Speak and understand English

Exclusion Criteria:

• Pregnancy or lactation

• Drug addiction defined as any use of cannabis, opioids or other addictive drugs

• Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).

• Lack of ability to cooperate

• Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids.

• Skin diseases

• Moles, scars or tattoos in the area to be treated or tested.

• Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex

• Consumption of alcohol or painkillers 24 hours before the study days and between these

• Acute or chronic pain

• Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Related Conditions & MeSH terms

• Itch

Intervention

Other:
• Papain
Papain will be applied using cowhage spicules inactivated by heat
• Histamine
To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
• Cowhage
Cowhage spicules are 1-2 mm in length and have a diameter of 1-3 µm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area.
• L-menthol
A 1 mL aliquot is dispensed onto a 2,5 × 2,5 cm cotton pad and placed on a 6 × 6 cm sheet of medical tape.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring itch intensity by computerized Visual Analog Scale Scoring	We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable	For 15 minutes
Primary	Measuring pain intensity by computerized Visual Analog Scale Scoring	We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".	For 15 minutes
Primary	Superficial blood perfusion measurement	Superficial blood perfusion is measured by a Speckle contrast imager	After 15 minutes
Primary	Measuring Alloknesis	Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force).	15 minutes
Secondary	Measurement of Cold Detection Thresholds (CDT)	The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.	15 minutes
Secondary	Measurement of Cold PainThresholds (CPT)	The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.	15 minutes
Secondary	Measurement of Heat Pain Thresholds (HPT)	The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.	15 minutes
Secondary	Measurement of Warm Detection Thresholds (WDT)	The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.	15 minutes
Secondary	Measurement of Pain to Supra-threshold Heat Stimuli	The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.	15 minutes
Secondary	Measurement of Mechanical Pain Thresholds (MPT)	This test is conducted using a pin-prick set.	15 minutes
Secondary	Measurement of Mechanical Pain Sensitivity (MPS)	This test is conducted using a pin-prick set.	15 minutes
Secondary	Touch Pleasantness (TP)	Pleasant touch sensation measured using a standardized sensory brush	15 minutes