Skip to main content
OpenTrials
Completed

NCT Number: NCT02570841

Pain Thresholds Under High-dose Topical Capsaicin

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia, Critical Care and Pain Medicine

Vienna, State of Vienna, 1090, Austria

About this study

Capsaicin is the main pungent ingredient in chili peppers. Topical capsaicin 8% is used for the treatment of peripheral neuropathic pain. Application of capsaicin 8% provokes distinct pain by activating the transient receptor potential vanilloid 1 (TRPV1) receptor. Cooling the skin results in a reliable prevention of the application pain. However, the necessary cooling temperature and if cooling itself produces application pain, is unknown.

Materials and Methods: 10 female and 10 male healthy volunteers will be enrolled in a randomised, double blind, placebo controlled, cross-over study. The left or right forearm of each subject is going to be treated with a capsaicin 8% patch (QUTENZA, Astellas Pharma, Tokyo, Japan) of 9 cm² or a placebo patch (Demo patch, Astellas Pharma, Tokyo, Japan) of the same size for 60 min. Then the other forearm (which has not been tested before) will be treated with the remaining patch. During capsaicin and placebo exposure HPT in °C and CPT in °C are going to be obtained by the thermode of a thermal sensory analyser, TSA-II (Medoc Ltd., Ramat Yishai, Israel). Temperature increase/decrease of the thermode will be stopped, as soon as the subject presses a switch because of a beginning pain sensation. Immediately after exposure a pin prick test will be performed 5 times in a row by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain (Mechanical pain threshold in g). 2 weeks later HPT, CPT, and MPT will be determined again in the areas of capsaicin and placebo exhibition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers 18 ore more years old

Exclusion criteria

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

Treatment and study plan

Topical High dose Capsaicin

Drug

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

Other names: Topical Capsaicin 8%, Qutenza® patch

Topical Placebo

Drug

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

Other names: Demo patch

Primary outcomes

  1. Heat pain threshold (HPT) in degrees Celsius (°C)

    Time frame: 60 minutes during topical highdose Capsaicin/Placebo exposure

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

Secondary outcomes

  1. Cold pain threshold (CPT) in degrees Celsius (°C)

    Time frame: 60 minutes during topical highdose Capsaicin/Placebo exposure

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

  2. Mechanical pain threshold (MPT) in grams (g)

    Time frame: Immediately after topical highdose Capsaicin/Placebo exposure

    After capsaicin and placebo exposure MPT in grams (g) is determined by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain

  3. HPT in degrees Celsius (°C)

    Time frame: 2 weeks after exposure

    HPT in degrees Celsius (°C) will be determined again in the areas of capsaicin and placebo Exhibition

  4. CPT in degrees Celsius (°C)

    Time frame: 2 weeks after exposure

    CPT in degrees Celsius (°C) will be determined again in the areas of capsaicin and placebo Exhibition

  5. MPT in grams (g)

    Time frame: 2 weeks after exposure

    MPT in grams (g) will be determined again in the areas of capsaicin and placebo Exhibition

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Astellas Pharma GmbH

Registry information

Official study title

Heat-, Cold-, and Mechanical Pain Thresholds Under Exposition of High Dose Topical Capsaicin

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2015
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.