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Completed

NCT Number: NCT01523951

Topical Local Anaesthesia and Cooling 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Spec. Anesthesia and Pain Therapy

Vienna, State of Vienna, 1090, Austria

About this study

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.

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

Treatment and study plan

Primary outcomes

  1. burning pain during the application of capsaicin 8% patch

    Time frame: 60 minutes

Secondary outcomes

  1. application pain within the first 24 hours after application of capsaicin 8% patch

    Time frame: 24 hours

  2. epidermal nerve fiber density(ENFD)

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Astellas Pharma GmbH

Registry information

Official study title

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

Acronym: LACCA

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2012
Registry last updated
Mar 20, 2012

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.

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