Pain Thresholds Under High-dose Topical Capsaicin

NCT ID: NCT02570841

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-09-30

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.

Detailed Description

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Capsaicin

Treatment with Topical High dose Capsaicin

Group Type: ACTIVE_COMPARATOR

Topical High dose Capsaicin

Intervention Type: DRUG

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

Placebo

Treatment with Topical Placebo

Group Type: PLACEBO_COMPARATOR

Topical Placebo

Intervention Type: DRUG

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

Interventions

Topical High dose Capsaicin

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

Intervention Type: DRUG

Topical Placebo

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

Intervention Type: DRUG

Other Intervention Names

Topical Capsaicin 8%; Qutenza® patch; Demo patch

Eligibility Criteria

Inclusion Criteria

• healthy volunteers 18 ore more years old

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

E. Knolle, MD

Ao.Univ.-Prof. Dr. Erich Knolle

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erich Knolle, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Critical Care and Pain Medicine

Locations

Department of Anesthesia, Critical Care and Pain Medicine

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

FA738B0401

Identifier Type: -

Identifier Source: org_study_id