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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma GmbH
Information provided by (Responsible Party):
E. Knolle, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01523951
First received: January 29, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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
Pain

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • burning pain during the application of capsaicin 8% patch [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • application pain within the first 24 hours after application of capsaicin 8% patch [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • epidermal nerve fiber density(ENFD) [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Skin biopsy


Enrollment: 12
Study Start Date: January 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy volunteers

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

healthy volunteers

Criteria

Inclusion Criteria:

  • healthy volunteers 18 ore more years old

Exclusion Criteria:

  • dermatologic or neurologic injuries on both thighs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523951

Locations
Austria
Dept. of Spec. Anesthesia and Pain Therapy
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Astellas Pharma GmbH
  More Information

No publications provided

Responsible Party: E. Knolle, MD, Ao.Univ.-Prof. Dr. Erich Knolle, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01523951     History of Changes
Other Study ID Numbers: 367/180-03/04, 2011-002264-25
Study First Received: January 29, 2012
Last Updated: March 19, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
topical local anaesthesia
cooling
capsaicin 8%
epidermal nerve fiber density
treatment pain

Additional relevant MeSH terms:
Anesthetics
Capsaicin
Antipruritics
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014