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Investigation of a New Human Model for Itch

Sponsor
Aalborg University (Other)
Overall Status
Completed
CT.gov ID
NCT04711044
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
5.1
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Papain
  • Other: Histamine
  • Other: Cowhage
  • Other: L-menthol
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

Other: Papain
Papain will be applied using cowhage spicules inactivated by heat

Other: Histamine
To deliver histamine, standard allergy skin prick test (SPT) lancets are applied

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Measuring itch intensity by computerized Visual Analog Scale Scoring [For 15 minutes]

    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

  2. Measuring pain intensity by computerized Visual Analog Scale Scoring [For 15 minutes]

    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".

  3. Superficial blood perfusion measurement [After 15 minutes]

    Superficial blood perfusion is measured by a Speckle contrast imager

  4. Measuring Alloknesis [15 minutes]

    Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force).

Secondary Outcome Measures

  1. Measurement of Cold Detection Thresholds (CDT) [15 minutes]

    The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.

  2. Measurement of Cold PainThresholds (CPT) [15 minutes]

    The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.

  3. Measurement of Heat Pain Thresholds (HPT) [15 minutes]

    The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.

  4. Measurement of Warm Detection Thresholds (WDT) [15 minutes]

    The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.

  5. Measurement of Pain to Supra-threshold Heat Stimuli [15 minutes]

    The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.

  6. Measurement of Mechanical Pain Thresholds (MPT) [15 minutes]

    This test is conducted using a pin-prick set.

  7. Measurement of Mechanical Pain Sensitivity (MPS) [15 minutes]

    This test is conducted using a pin-prick set.

  8. Touch Pleasantness (TP) [15 minutes]

    Pleasant touch sensation measured using a standardized sensory brush

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

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aalborg University Aalborg Nordjylland Denmark 9229

Sponsors and Collaborators

  • Aalborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvia Lo Vecchio, PhD, Assistant Professor, Aalborg University
ClinicalTrials.gov Identifier:
NCT04711044
Other Study ID Numbers:
  • N-20200005 (third sub-project)
First Posted:
Jan 15, 2021
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Menthol
Histamine

Study Results

No Results Posted as of Jul 9, 2021