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    Clinical Trial Results:
    Calcium electroporation for basal cell carcinomas – a ’Proof of concept’ study

    Summary
    EudraCT number
    		 2019-002730-36
    Trial protocol
    		 DK  
    Global end of trial date
    29 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2023
    First version publication date
    13 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CaEP68962
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Dermatology, Bispebjerg Hospital
    Sponsor organisation address
    Nielsine Nielsens Vej 9, Copenhagen NV, Denmark, 2400
    Public contact
    Stine Regin Wiegell, Department of Dermatology, Bispebjerg Hospital, stine.regin.wiegell@regionh.dk
    Scientific contact
    Stine Regin Wiegell, Department of Dermatology, Bispebjerg Hospital, 0045 30914617, stine.regin.wiegell@regionh.dk
    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
    30 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of calcium electroporation in the treatment of primary low risk basal cell carcinomas
    Protection of trial subjects
    Local anaesthetics before electroporation
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2019
    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
    Denmark: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    5
    From 65 to 84 years
    18
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited among patients refered to Bispebjerg hospital for the treatment of primary BCC

    Pre-assignment
    Screening details
    		 Patients refeered to hospital for treatment of primary basal cell carcionmer

    Period 1
    Period 1 title
    intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calciumchlorid "SAD"
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Injection of calcium chloride 9 mg/ml before electroporation

    Number of subjects in period 1
    		intervention
    Started
    25
    Completed
    21
    Not completed
    4
         Consent withdrawn by subject
    2
         Chemotherapy for internal cancer
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 -

    Reporting group values
    		 intervention Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 18 18
        85 years and over
    		 2 2
        18-64 years
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 74 (50 to 93) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    		 -

    Primary: Complete response

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    End point title
    		 Complete response [1]
    End point description
    End point type
    Primary
    End point timeframe
    3 months after last treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were possible due to the low number of patients treated (25) and only descriptive primary end point
    End point values
    		 intervention
    Number of subjects analysed
    24
    Units: Number of lesions in complete response
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 year after treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenectomy
    Additional description: Removal of lymph node for diagnostics
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    Skin and subcutaneous tissue disorders
    Necrosis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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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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