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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01523951
Collaborator
Astellas Pharma GmbH (Industry)
12
Enrollment
1
Location
2
Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Comparison of Topical Local Anaesthesia and Cooling to Reduce the Burning Pain During Capsaicin 8% Patch Application
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Mar 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. burning pain during the application of capsaicin 8% patch [60 minutes]

    Secondary Outcome Measures

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

    2. epidermal nerve fiber density(ENFD) [1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy volunteers 18 ore more years old
    Exclusion Criteria:
    • dermatologic or neurologic injuries on both thighs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Spec. Anesthesia and Pain Therapy Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna
    • Astellas Pharma GmbH

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    E. Knolle, MD, Ao.Univ.-Prof. Dr. Erich Knolle, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT01523951
    Other Study ID Numbers:
    • 367/180-03/04
    • 2011-002264-25
    First Posted:
    Feb 1, 2012
    Last Update Posted:
    Mar 20, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by E. Knolle, MD, Ao.Univ.-Prof. Dr. Erich Knolle, Medical University of Vienna
    topical local anaesthesia
    cooling
    capsaicin 8%
    epidermal nerve fiber density
    treatment pain

    Study Results

    No Results Posted as of Mar 20, 2012