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    Clinical Trial Results:
    Epidermal Nerve Fibre Density Reduction as a Function of Application Time of topical high-dose and low-dose Capsaicin

    Summary
    EudraCT number
    		 2012-002406-46
    Trial protocol
    		 AT  
    Global end of trial date
    03 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2020
    First version publication date
    02 Jun 2020
    Other versions
    Summary report(s)
    		 Summary Capsaicin

    Trial information

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    Trial identification
    Sponsor protocol code
    08.10.2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Dept. of Anaesthesia, Intensive Care and Pain Management, Medical University Vienna, 0043 1404004108, joerg.hiesmayr@meduniwien.ac.at
    Scientific contact
    Dept. of Anaesthesia, Intensive Care and Pain Management, Medical University Vienna, 0043 1404004108, joerg.hiesmayr@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of the effect of increasing application time of different Capsaicin doses on the density of epidermal nerve fibres
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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
    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
    Period 1 title
    Capsaicin Application (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    randomised, placebo-controlled, observer-blinded trail

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 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%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    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.

    Arm title
    		 Capsaicin 8%
    Arm description
    		 Each participant got capsaicin 8% patch (active comparator) on the other thigh
    Arm type
    		 Experimental

    Investigational medicinal product name
    Qutenza
    Investigational medicinal product code
    EU/1/09/524/001
    Other name
    Capsaicin 8% patch
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    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.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: randomised, placebo-controlled, observer-blinded trail
    Number of subjects in period 1
    		Capsaicin 0,05 % Capsaicin 8%
    Started
    12
    12
    Skin biopsy week 1
    12
    12
    Skin biopsy week 5
    12
    12
    Capsaicin application
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Capsaicin 0,05 %
    Reporting group description
    		 Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh

    Reporting group title
    Capsaicin 8%
    Reporting group description
    		 Each participant got capsaicin 8% patch (active comparator) on the other thigh

    Reporting group values
    		 Capsaicin 0,05 % Capsaicin 8% Total
    Number of subjects
    		 12 12 12
    Age categorical
    Healthy adult volunteers aged 18-64 years where included
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 12 12 12
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6 6
        Male
    		 6 6 6

    End points

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    End points reporting groups
    Reporting group title
    Capsaicin 0,05 %
    Reporting group description
    		 Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh

    Reporting group title
    Capsaicin 8%
    Reporting group description
    		 Each participant got capsaicin 8% patch (active comparator) on the other thigh

    Primary: Change in epidermal nerve fibre density without capsaicin treatment and one week after capsaicin treatment

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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
    End point type
    Primary
    End point timeframe
    Epidermal nerve fibre density one week after the capsaicin treatment
    End point values
    		 Capsaicin 0,05 % Capsaicin 8%
    Number of subjects analysed
    12
    12
    Units: 0,1
        arithmetic mean (standard deviation)
    15.2 ( 7.4 )
    11.9 ( 7.8 )
    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.
    Comparison groups
    Capsaicin 0,05 % v Capsaicin 8%
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation

    Secondary: Change in epidermal nerve fibre density without capsaicin treatment and five weeks after capsaicin treatment

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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
    End point type
    Secondary
    End point timeframe
    Epidermal nerve fibre density five weeks after capsaicin treatment
    End point values
    		 Capsaicin 0,05 % Capsaicin 8%
    Number of subjects analysed
    12
    12
    Units: 0,1
        arithmetic mean (standard deviation)
    16.1 ( 6.2 )
    14.8 ( 6.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study period
    Adverse event reporting additional description
    daily questionnaire; volunteers hab to indicate pain, swelling, rubor at the capsaicin application sites on the skin
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Capsaicin 0,05 %
    Reporting group description
    		 Each participant got capsaicin 0,05% ointment (active comparator) on the one thigh

    Reporting group title
    Capsaicin 8%
    Reporting group description
    		 Each participant got capsaicin 8% patch (active comparator) on the other thigh

    Serious adverse events
    		 Capsaicin 0,05 % Capsaicin 8%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Capsaicin 0,05 % Capsaicin 8%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 12 (66.67%)
    5 / 12 (41.67%)
    Skin and subcutaneous tissue disorders
    Pain of skin
    Additional description: some participants indicated capsaicin related application pain - with a maximum pain level of 2 on the visual analog scale from 0-10 (no pain - maximum pain)
         subjects affected / exposed
    8 / 12 (66.67%)
    5 / 12 (41.67%)
         occurrences all number
    8
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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