NCT02570841

Brief Summary

Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators want to find out the mechanical pain threshold in g from topical capsaicin and to verify a prolonged effect of capsaicin on the pain thresholds.

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 phase_4 pain

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_4 pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

September 8, 2015

Last Update Submit

October 5, 2015

Conditions

Pain

Keywords

Heat pain thresholdCold pain thresholdMechanical pain thresholdHigh dose Capsaicin

Outcome Measures

Primary Outcomes (1)

  • Heat pain threshold (HPT) in degrees Celsius (°C)

    During capsaicin and placebo exposure HPT in degrees Celsius (°C) is determined by a thermal sensory analyser TSA-II (Medoc Ltd.)

    60 minutes during topical highdose Capsaicin/Placebo exposure

Secondary Outcomes (5)

  • Cold pain threshold (CPT) in degrees Celsius (°C)

    60 minutes during topical highdose Capsaicin/Placebo exposure

  • Mechanical pain threshold (MPT) in grams (g)

    Immediately after topical highdose Capsaicin/Placebo exposure

  • HPT in degrees Celsius (°C)

    2 weeks after exposure

  • CPT in degrees Celsius (°C)

    2 weeks after exposure

  • MPT in grams (g)

    2 weeks after exposure

Study Arms (2)

Capsaicin

ACTIVE COMPARATOR

Treatment with Topical High dose Capsaicin

Drug: Topical High dose Capsaicin

Placebo

PLACEBO COMPARATOR

Treatment with Topical Placebo

Drug: Topical Placebo

Interventions

Topical High dose CapsaicinDRUG

Topical High dose Capsaicin exposure within an area of 3x3 cm for 60 minutes

Also known as: Topical Capsaicin 8%, Qutenza® patch
Capsaicin
Topical PlaceboDRUG

Placebo exposure within an area of 3x3 cm for 60 minutes

Also known as: Demo patch
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers 18 ore more years old

You may not qualify if:

  • dermatologic or neurologic injuries on both thighs, (possible) pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Critical Care and Pain Medicine

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Neurologic 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 Officials

  • Erich Knolle, MD

    Department of Anesthesia, Critical Care and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr. Erich Knolle

Study Record Dates

First Submitted

September 8, 2015

First Posted

October 7, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

AU(1)