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Investigation of a New Human Model for Itch

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04711044
Enrollment
20
Registered
2021-01-15
Start date
2021-02-01
Completion date
2021-07-05
Last updated
2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itch

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.

Interventions

OTHERPapain

Papain will be applied using cowhage spicules inactivated by heat

OTHERHistamine

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

OTHERCowhage

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.

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.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Measuring itch intensity by computerized Visual Analog Scale ScoringFor 15 minutesWe 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
Measuring pain intensity by computerized Visual Analog Scale ScoringFor 15 minutesWe 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.
Superficial blood perfusion measurementAfter 15 minutesSuperficial blood perfusion is measured by a Speckle contrast imager
Measuring Alloknesis15 minutesAlloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force).

Secondary

MeasureTime frameDescription
Measurement of Pain to Supra-threshold Heat Stimuli15 minutesThe tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Mechanical Pain Thresholds (MPT)15 minutesThis test is conducted using a pin-prick set.
Measurement of Cold Detection Thresholds (CDT)15 minutesThe tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Touch Pleasantness (TP)15 minutesPleasant touch sensation measured using a standardized sensory brush
Measurement of Mechanical Pain Sensitivity (MPS)15 minutesThis test is conducted using a pin-prick set.
Measurement of Cold PainThresholds (CPT)15 minutesThe tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Heat Pain Thresholds (HPT)15 minutesThe tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Warm Detection Thresholds (WDT)15 minutesThe tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026