Clinical Trial Results:
Epidermal Nerve Fibre Density Reduction as a Function of Application Time of topical high-dose and low-dose Capsaicin
Summary
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EudraCT number |
2012-002406-46 |
Trial protocol |
AT |
Global end of trial date |
03 Apr 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jun 2020
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First version publication date |
02 Jun 2020
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Other versions |
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Summary report(s) |
Summary Capsaicin |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
08.10.2012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Medical University Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
Dept. of Anaesthesia, Intensive Care and Pain Management, Medical University Vienna, 0043 1404004108, joerg.hiesmayr@meduniwien.ac.at
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Scientific contact |
Dept. of Anaesthesia, Intensive Care and Pain Management, Medical University Vienna, 0043 1404004108, joerg.hiesmayr@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Feb 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Apr 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Apr 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Comparison of the effect of increasing application time of different Capsaicin doses on the density of epidermal nerve fibres
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Protection of trial subjects |
If the application of the capsaicin patch on the skin was painful for the study participants, the volunteers could request pain-killers on demand.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment took place from August 2012 till October 2012. The healthy volunteers where recruited by notices at the black boards at the Medical University Vienna. Participants were mainly recruited from medical students. | ||||||||||||||||||
Pre-assignment
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Screening details |
Only healthy volunteers were included. During the screening visit participants where evaluated regarding their over all health and in particular a neurological status was assessed. Only non-pregnant women were included. Pregnancy tests were conducted prior to inclusion. Twelve subject where screened and all could be included. | ||||||||||||||||||
Period 1
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Period 1 title |
Capsaicin Application (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||
Roles blinded |
Investigator [1] | ||||||||||||||||||
Blinding implementation details |
randomised, placebo-controlled, observer-blinded trail
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Capsaicin 0,05 % | ||||||||||||||||||
Arm description |
Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Capsaicin 0,05%
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Capsaicin 0,05% ointment was administered to five pre-defined areas (size 3x3cm) on one thigh - a sixth area remained untreated as reference area.
After certain points of time, one blob of ointment after the other was removed consecutively in a randomised manner.
One week and five weeks after the application, one skin punch biospy was taken of every application area and the epidermal nerve fibre density was analysed.
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Arm title
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Capsaicin 8% | ||||||||||||||||||
Arm description |
Each participant got capsaicin 8% patch (active comparator) on the other thigh | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Qutenza
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Investigational medicinal product code |
EU/1/09/524/001
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Other name |
Capsaicin 8% patch
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Pharmaceutical forms |
Transdermal patch
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Routes of administration |
Transdermal use
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Dosage and administration details |
Pieces (size 3x3cm) of a Capsaicin 8% patch were administered to five pre-defined areas on one thigh - a sixth area remained untreated as reference area.
After certain points of time, one patch after the other was removed consecutively in a randomised manner.
One week and five weeks after the application, one skin punch biospy was taken of every application area and the epidermal nerve fibre density was analysed.
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Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: randomised, placebo-controlled, observer-blinded trail |
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Baseline characteristics reporting groups
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Reporting group title |
Capsaicin 0,05 %
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Reporting group description |
Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Capsaicin 8%
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Reporting group description |
Each participant got capsaicin 8% patch (active comparator) on the other thigh | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Capsaicin 0,05 %
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Reporting group description |
Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh | ||
Reporting group title |
Capsaicin 8%
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Reporting group description |
Each participant got capsaicin 8% patch (active comparator) on the other thigh |
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End point title |
Change in epidermal nerve fibre density without capsaicin treatment and one week after capsaicin treatment | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Epidermal nerve fibre density one week after the capsaicin treatment
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Statistical analysis title |
ANOVA | ||||||||||||
Statistical analysis description |
Analysis was performed with an ANOVA for Latin squares, in the course
of a Randomised Block Factorial Design, whereas the different capsaicin dosages
and application durations are specified as inner-block factors. For analysis of the
impact of gender this ANOVA was extended to a Split-Plot Design. For recognition of
discordant values or skewness of distribution, testing of the residues was preceded
to all statistical analysis.
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Comparison groups |
Capsaicin 0,05 % v Capsaicin 8%
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Number of subjects included in analysis |
24
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Analysis specification |
Post-hoc
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Analysis type |
other | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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End point title |
Change in epidermal nerve fibre density without capsaicin treatment and five weeks after capsaicin treatment | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Epidermal nerve fibre density five weeks after capsaicin treatment
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Study period
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Adverse event reporting additional description |
daily questionnaire; volunteers hab to indicate pain, swelling, rubor at the capsaicin application sites on the skin
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Assessment type |
Non-systematic | ||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Capsaicin 0,05 %
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Reporting group description |
Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh | ||||||||||||||||||||||||
Reporting group title |
Capsaicin 8%
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Reporting group description |
Each participant got capsaicin 8% patch (active comparator) on the other thigh | ||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Oct 2012 |
In addition the to evaluation of the density of epidermal nerve fibers one week after the capsaicin application, the amendment was introduced to be able to evaluate the epidermal nerve fibres five weeks after the capsaicin application. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
the number of participants of twelve was small |