Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application (LACCA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01523951|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : March 20, 2012
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|
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|
|Actual Enrollment :||12 participants|
|Official Title:||A Comparison of Topical Local Anaesthesia and Cooling to Reduce the Burning Pain During Capsaicin 8% Patch Application|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
- burning pain during the application of capsaicin 8% patch [ Time Frame: 60 minutes ]
- application pain within the first 24 hours after application of capsaicin 8% patch [ Time Frame: 24 hours ]
- epidermal nerve fiber density(ENFD) [ Time Frame: 1 week ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523951
|Dept. of Spec. Anesthesia and Pain Therapy|
|Vienna, Austria, 1090|