NCT02769910

Brief Summary

The purpose of this project is to investigate the effect of capsaicin-induced neurogenic inflammation with three different intensities on itch subsequently induced by histamine and cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation significantly increases susceptibility to itch provocations with cowhage and histamine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

May 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

May 10, 2016

Last Update Submit

November 19, 2016

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

  • Itch intensity

    Rating of the perceived itch intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz.

    Assessed continuously at 0-10 minutes following itch provocation

Secondary Outcomes (5)

  • Neurogenic inflammation

    Assessed 11 minutes after itch provocation

  • Changes in sensitivity to touch-evoked itch

    Assessed before, and at 12-15 minutes following itch provocation

  • Wheal size

    Assessed at 10 minutes following itch provocation

  • Pain intensity

    Assessed continuously at 0-10 minutes following itch provocation

  • Pain during capsaicin application

    24 hours after first application of capsaicin patch

Study Arms (2)

Cowhage

OTHER

Cowhage is used to induce non-histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hours and Qutenza Demo Patch.

Drug: Capsaicin 24 HoursDrug: Capsaicin 1 HourOther: Qutenza Demo Patch

Histamine

OTHER

Histamine is used to induce histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch.

Drug: Capsaicin 24 HoursDrug: Capsaicin 1 HourOther: Qutenza Demo Patch

Interventions

Capsaicin 24 HoursDRUG

Dermal patches for transdermal application of Capsaicin, applied for 24 hours

Also known as: Qutenza
CowhageHistamine
Capsaicin 1 HourDRUG

Dermal patches for transdermal application of Capsaicin, applied for 1 hour

Also known as: Qutenza
CowhageHistamine
Qutenza Demo PatchOTHER

Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.

Also known as: Qutenza Demo
CowhageHistamine

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids or other drugs
  • Previous or current neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial
  • Skin diseases
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Moles or tattoos in the area to be irradiated
  • Exposure of the irradiated area to UV radiation (e.g., sun) 48 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)

SMI

Aalborg, NJ, 9220, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc. Med., Phd. Stud.

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)