NCT04711044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

January 13, 2021

Last Update Submit

July 8, 2021

Conditions

Itch

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Superficial blood perfusion measurement

    Superficial blood perfusion is measured by a Speckle contrast imager

    After 15 minutes

  • 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 Outcomes (8)

  • Measurement of Cold Detection Thresholds (CDT)

    15 minutes

  • Measurement of Cold PainThresholds (CPT)

    15 minutes

  • Measurement of Heat Pain Thresholds (HPT)

    15 minutes

  • Measurement of Warm Detection Thresholds (WDT)

    15 minutes

  • Measurement of Pain to Supra-threshold Heat Stimuli

    15 minutes

  • +3 more secondary outcomes

Study Arms (1)

Study group

EXPERIMENTAL
Other: PapainOther: HistamineOther: CowhageOther: L-menthol

Interventions

PapainOTHER

Papain will be applied using cowhage spicules inactivated by heat

Study group
HistamineOTHER

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

Study group
CowhageOTHER

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.

Study group
L-mentholOTHER

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.

Study group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • years
  • Speak and understand English

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9229, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

PapainHistamineMenthol

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidasesBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological FactorsCyclohexanolsHexanolsFatty AlcoholsAlcoholsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

February 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 5, 2021

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations

DK(1)