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    Clinical Trial Results:
    Treatment of Actinic Keratoses with Ingenol Mebutate and topical glucocorticosteroid - a safety study

    Summary
    EudraCT number
    		 2013-002583-80
    Trial protocol
    		 DK  
    Global end of trial date
    28 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2021
    First version publication date
    27 Nov 2021
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    38814
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Dermatology, Bispebjerg University Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen, Denmark, 2400
    Public contact
    Clinical Trail Information, Department of Dermatology, Bispebjerg University Hospital, +45 60668830, andres.erlendsson@gmail.com
    Scientific contact
    Clinical Trail Information, Department of Dermatology, Bispebjerg University Hospital, +45 60668830, andres.erlendsson@gmail.com
    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
    28 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective is to investigate whether local skin responses seen after Picato® can be treated with a topical glucocorticosteroid. Secondary objective is to investigate if the treatment efficacy is affected by it. It is the perspective of this study to be offer patients safe treatment of local skin responses after Picato® treatment while maintaining an effective eradication of the Actinic Keratoses.
    Protection of trial subjects
    Outlined in protocol. Field treatment often causes local skin responses and in the case of severe LSR a glucocorticosteroid would be administered in a normal clinical setting. The subject came to regular follow-ups to address any side effects and had a phone number to the treating physician they could call at any time in between visits.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    7
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients, 18 years or older with multiple actinic keratosis and field cancerization in face or scalp were recruited for participation. Patients were recruited between September 2013 and November 2014 at Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.

    Pre-assignment
    Screening details
    		 Patients refereed with actinic keratosis to Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark, were screened for participation. . Inclusion required two similar treatment areas of 25 cm2 containing a minimum of seven AKs on field-cancerized skin.

    Pre-assignment period milestones
    Number of subjects started
    		 21
    Number of subjects completed
    		 21

    Period 1
    Period 1 title
    STUDY PERIOD (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Investigator was blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 INT/CONTR
    Arm description
    		 Each subject was its own control. Control: Ingenol mebutate. Intervention: Ingenol mebutate + clobetasol propionate
    Arm type
    		 INT/CONTR

    Investigational medicinal product name
    Picato
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    External use
    Dosage and administration details
    Applied on day 1,2 and 3, or day 1 and 2.

    Arm title
    		 NULL
    Arm description
    		 Made up arm because of faulty reporting system.
    Arm type
    		 NULL

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		INT/CONTR NULL
    Started
    20
    1
    Completed
    20
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    STUDY PERIOD
    Reporting group description
    		 -

    Reporting group values
    		 STUDY PERIOD Total
    Number of subjects
    		 21 21
    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)
    		 7 7
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    INT/CONTR
    Reporting group description
    		 Each subject was its own control. Control: Ingenol mebutate. Intervention: Ingenol mebutate + clobetasol propionate

    Reporting group title
    NULL
    Reporting group description
    		 Made up arm because of faulty reporting system.

    Primary: Local skin response in control vs intervention day 4

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    End point title
    		 Local skin response in control vs intervention day 4
    End point description
    End point type
    Primary
    End point timeframe
    Assessed days 1, 4, 8, 15, 57
    End point values
    		 INT/CONTR NULL
    Number of subjects analysed
    20
    1
    Units: LSR 0-24
        number (not applicable)
    9.95
    9.95
    Statistical analysis title
    		 STAT
    Comparison groups
    INT/CONTR v NULL
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 9.37
         upper limit
    		 10.53
    Variability estimate
    Standard deviation
    Notes
    [1] - Kolmogorov-Smirnov test indicated normal distribution for LSR, pain, and pruritus and was compared using paired t test. Wilcoxon signed rank test compared clearance rates and cosmetic outcome, while McNemar test compared paired ratios of complete clearance. Clearance of grade I to III AK was pooled for all patients and presented as clearance rates in the population. P values were 2-sided and considered statistically significant when less than .05.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 months
    Adverse event reporting additional description
    Local skin responses were seen assessed at each visit. No clinical hypopigmentation or hyperpigmentation was observed. One patient got an E-coli/Enterococcal infection in the treatment area receiving ingenol mebutate + clobetasole, which after relevant antibiotic treatment left a cicatrix.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CT-3
    Dictionary version
    2011
    Reporting groups
    Reporting group title
    STUDY/CONTROL
    Reporting group description
    		 Each subject was its own control. Control: Ingenol mebutate. Intervention: Ingenol mebutate + clobetasol propionate

    Serious adverse events
    		 STUDY/CONTROL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 STUDY/CONTROL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    Infections and infestations
    Adverse reaction
    Additional description: E-coli infection in the skin of treated area. Assessed as a moderate adverse reaction (causes the patient discomfort) and needed therapeutic intervention. At follow up, a cicatrix was noted in the previously infected area.
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

    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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