PainLACCANCT01523951
Topical Local Anaesthesia and Cooling During Capsaicin 8% Patch Application
An observational study of Pain, run by Medical University of Vienna at 1 site in Austria.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers
Who may be able to join
- healthy volunteers 18 ore more years old
Who cannot join
- dermatologic or neurologic injuries on both thighs
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Spec. Anesthesia and Pain Therapy
Vienna, State of Vienna, 1090
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Keywords
- topical local anaesthesia, cooling, capsaicin 8%, epidermal nerve fiber density, treatment pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
burning pain during the application of capsaicin 8% patch
Measured: 60 minutes
Secondary outcomes (2)
application pain within the first 24 hours after application of capsaicin 8% patch
Measured: 24 hours
epidermal nerve fiber density(ENFD)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma GmbH
- Responsible party
- Principal investigator, E. Knolle, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523951
- Sponsor's protocol ID
- 367/180-03/04
- Other IDs
- 2011-002264-25
- Acronym
- LACCA
- Status last verified
- Mar 2012
- First submitted
- 29 Jan 2012
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Topical Local Anaesthesia and Cooling to Reduce the Burning Pain During Capsaicin 8% Patch Application
- ClinicalTrials.gov ID
- NCT01523951
- Acronym / sponsor ID
- LACCA / 367/180-03/04
- Conditions
- Pain
- Keywords
- topical local anaesthesia, cooling, capsaicin 8%, epidermal nerve fiber density, treatment pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Astellas Pharma GmbH
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers
Key inclusion criteria (1 listed)
- healthy volunteers 18 ore more years old
Key exclusion criteria (1 listed)
- dermatologic or neurologic injuries on both thighs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
burning pain during the application of capsaicin 8% patch
Time frame: 60 minutes
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
burning pain during the application of capsaicin 8% patch (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.