Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application (LACCA)

A Comparison of Topical Local Anaesthesia and Cooling to Reduce the Burning Pain During Capsaicin 8% Patch Application

Aim of the study is to demonstrate superiority of a continuous cooling of the skin over topical EMLA or placebo in reducing the burning pain during the application of capsaicin 8% patch ("Qutenza").

Secondary it will be tested, if the 2 different pre-treatments have an effect on the application pain within the first 24 hours, and if different pre-treatments have an effect on the reduction of the epidermal nerve fiber density (ENFD) 1 week after Qutenza application.

Study Overview

• Status: Completed
• Conditions: Pain

Detailed Description

According to literature, one of the most common adverse events of capsaicin 8% patch is a burning pain and a reversible erythema at the application site. In general it is recommended to apply a topical anesthetic one hour before capsaicin 8% patch application, or to treat the pain with cooling, NSAIDs or even opioids. Nevertheless, there is still only limited data available on the effects and side-effects. In this study it shall be tested if cooling the skin down for about 5-10 Celsius, immediately before Qutenza is applied, and continuing the cooling during the whole application time, results in a reliable prevention of the burning pain compared to pretreatment with topical anesthesia applied one hour in advance. This would lead to the assumption that the application pain is predominantly caused by a decrease of the threshold for heat pain beyond skin temperature and can therefore be prevented by a lowering of the skin temperature.

By ascertaining pain 24 hours after capsaicin 8% patch application and epidermal nerve fiber density (ENFD) 1 week after capsaicin 8% patch application it shall be proved if the different pretreatment methods do not change the secondary effects of capsaicin application.

If results turn out to be positive, it would be a massive relief with regard to time management and rescue medication.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Dept. of Spec. Anesthesia and Pain Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

healthy volunteers

Description

Inclusion Criteria:

• healthy volunteers 18 ore more years old

Exclusion Criteria:

• dermatologic or neurologic injuries on both thighs

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
burning pain during the application of capsaicin 8% patch	60 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
application pain within the first 24 hours after application of capsaicin 8% patch	24 hours
epidermal nerve fiber density(ENFD)	1 week

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Astellas Pharma GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 29, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): March 20, 2012
• Last Update Submitted That Met QC Criteria: March 19, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: cooling; epidermal nerve fiber density; topical local anaesthesia; capsaicin 8%; treatment pain
• Other Study ID Numbers: 367/180-03/04; 2011-002264-25 (EudraCT Number)