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    Clinical Trial Results:
    An open monocentric pilot study to investigate the potential of imiquimod 5% cream to detect residual and to prevent recurrence of lentigo maligna after surgical excision

    Summary
    EudraCT number
    		 2010-019422-13
    Trial protocol
    		 AT  
    Global end of trial date
    02 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2024
    First version publication date
    21 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Neue Stiftingtalstraße 6, Graz, Austria, 8010
    Public contact
    Principal investigator Department of Dermatology and Venereology, Medical University of Graz Department of Dermatology and Venereology, peter.wolf@medunigraz.at
    Scientific contact
    Principal investigator Department of Dermatology and Venereology, Medical University of Graz Department of Dermatology and Venereology, peter.wolf@medunigraz.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
    11 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to investigate the potential of Imiquimod 5% cream to eliminate possible subclinical lesions of lentigo maligna (LM) that resides after surgical excision by determining the long-term recurrence rates.
    Protection of trial subjects
    The study was conducted according to Good Clinical Practice standards and according to applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Mar 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    23
    From 65 to 84 years
    35
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period lasted from 2011 to 2016.

    Pre-assignment
    Screening details
    		 A total of 60 patients were recruited. 7 patients didn`t start study therapy due to withdrawal of consent (4x), or protocol deviations regarding the timepoint of therapy initiation (2x). One patient was a screening failure

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

    Arms
    Arm title
    		 Imiquimod
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imiquimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Aldara® cream was applied post-surgery to the study treatment area (STA), defined as the area within a range of 5cm of treatment margins to each side of the original scar of the excision. Time period between removal of stitches and first administration of Aldara® has not been shorter than 4 weeks. At first Aldara® was applied 3x/week on the scar and on the perilesional area (5cm). After two weeks of treatment the inflammation response was assessed. If there was no inflammation detectable in the STA, application was extended to 5x/week. After four weeks of treatment the inflammation response was assessed again. If there was still no inflammation detectable, application was extended to daily use. The total treatment cycle was up to 12 weeks, if tolerated by the patient.

    Number of subjects in period 1 [1]
    		Imiquimod
    Started
    53
    Completed
    49
    Not completed
    4
         Lost to follow-up
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 60 patients signed Informed Consent and were therefore considered "enrolled". 7 patients never started study treatment due to withdrawal of consent (4x), protocol deviatons (2x) or screening failure (1x).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 53 53
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 64.5 (33 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 31 31

    End points

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

    Primary: Percentage of patients having a relapse

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    End point title
    		 Percentage of patients having a relapse [1]
    End point description
    End point type
    Primary
    End point timeframe
    5 years
    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: Only descriptive statistical analysis was performed
    End point values
    		 Imiquimod
    Number of subjects analysed
    49
    Units: percent
        number (not applicable)
    8.2
    No statistical analyses for this end point

    Primary: Percentage of Lentigo Maligna patients with a relapse

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    End point title
    		 Percentage of Lentigo Maligna patients with a relapse [2]
    End point description
    Lentigo Maligna patients with complete excision and uncertain completed excision
    End point type
    Primary
    End point timeframe
    5 years
    Notes
    [2] - 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: Only descriptive analysis was performed
    End point values
    		 Imiquimod
    Number of subjects analysed
    28
    Units: percent
        number (not applicable)
    0
    No statistical analyses for this end point

    Primary: Percentage of Lentigo Maligna Melanoma patients with a relapse

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    End point title
    		 Percentage of Lentigo Maligna Melanoma patients with a relapse [3]
    End point description
    End point type
    Primary
    End point timeframe
    5 years
    Notes
    [3] - 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: Only descriptive analysis was performed
    End point values
    		 Imiquimod
    Number of subjects analysed
    21
    Units: percent
        number (not applicable)
    19
    No statistical analyses for this end point

    Primary: Relapse free time after surgery plus application of Imiquimod

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    End point title
    		 Relapse free time after surgery plus application of Imiquimod [4]
    End point description
    Relapse free time after surgery followed by application of imiquimod, for patients having a recurrence of LM/LMM in the Study treatment area.
    End point type
    Primary
    End point timeframe
    5 years
    Notes
    [4] - 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: Only descriptive analysis was performed
    End point values
    		 Imiquimod
    Number of subjects analysed
    49
    Units: Months
        First patient with a relapse
    2
        Second patient with a relapse
    5
        Third patient with a relapse
    28
        Fourth patient with a relapse
    36
    No statistical analyses for this end point

    Primary: Reccurrence free rate

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    End point title
    		 Reccurrence free rate [5]
    End point description
    End point type
    Primary
    End point timeframe
    5 years
    Notes
    [5] - 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: Only descriptive analysis was performed
    End point values
    		 Imiquimod
    Number of subjects analysed
    32
    Units: percent
        number (not applicable)
    91.84
    No statistical analyses for this end point

    Secondary: Side effect: Erythema, week 2

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    End point title
    		 Side effect: Erythema, week 2
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    51
    Units: Number of patients
        Severity index 0, men
    12
        Severity index 0, women
    14
        Severity index 1, men
    6
        Severity index 1, women
    7
        Severity index 2, men
    8
        Severity index 2, women
    4
        Severity index 3, men
    0
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, oedema, week 2

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    End point title
    		 Side effect, oedema, week 2
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    51
    Units: Number of patients
        Severity index 0, men
    19
        Severity index 0, women
    17
        Severity index 1, men
    5
        Severity index 1, women
    8
        Severity index 2, men
    2
        Severity index 2, women
    0
        Severity index 3, men
    0
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, Blister, week 2

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    End point title
    		 Side effect, Blister, week 2
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    51
    Units: Number of patients
        Severity index 0, men
    25
        Severity index 0, women
    23
        Severity index 1, men
    1
        Severity index 1, women
    1
        Severity index 2, men
    0
        Severity index 2, women
    1
        Severity index 3, men
    0
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, erosion, week 2

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    End point title
    		 Side effect, erosion, week 2
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    51
    Units: Number of patients
        Severity index 0, men
    20
        Severity index 0, women
    18
        Severity index 1, men
    4
        Severity index 1, women
    5
        Severity index 2, men
    2
        Severity index 2, women
    2
        Severity index 3, men
    0
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect: Encrustation, week 2

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    End point title
    		 Side effect: Encrustation, week 2
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    51
    Units: Number of patients
        Severity index 0, men
    23
        Severity index 0, women
    20
        Severity index 1, men
    3
        Severity index 1, women
    4
        Severity index 2, men
    0
        Severity index 2, women
    1
        Severity index 3, men
    0
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect; erythema, week 4

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    End point title
    		 Side effect; erythema, week 4
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    8
        Severity index 0, women
    8
        Severity index 1, men
    5
        Severity index 1, women
    5
        Severity index 2, men
    7
        Severity index 2, women
    6
        Severity index 3, men
    2
        Severity index 3, women
    2
        Severity index 4, men
    0
        Severity index 4, women
    1
    No statistical analyses for this end point

    Secondary: Side effect: Oedema, week 4

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    End point title
    		 Side effect: Oedema, week 4
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    12
        Severity index 0, women
    14
        Severity index 1, men
    7
        Severity index 1, women
    3
        Severity index 2, men
    1
        Severity index 2, women
    4
        Severity index 3, men
    1
        Severity index 3, women
    0
        Severity index 4, men
    1
        Severity index 4, women
    1
    No statistical analyses for this end point

    Secondary: Side effect, blister, week 4

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    End point title
    		 Side effect, blister, week 4
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    18
        Severity index 0, women
    16
        Severity index 1, men
    3
        Severity index 1, women
    3
        Severity index 2, men
    0
        Severity index 2, women
    2
        Severity index 3, men
    1
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    1
    No statistical analyses for this end point

    Secondary: Side effect: erosion, week 4

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    End point title
    		 Side effect: erosion, week 4
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    14
        Severity index 0, women
    14
        Severity index 1, men
    5
        Severity index 1, women
    3
        Severity index 2, men
    2
        Severity index 2, women
    2
        Severity index 3, men
    1
        Severity index 3, women
    1
        Severity index 4, men
    0
        Severity index 4, women
    2
    No statistical analyses for this end point

    Secondary: Side effect, encrustation, week 4

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    End point title
    		 Side effect, encrustation, week 4
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    15
        Severity index 0, women
    12
        Severity index 1, men
    3
        Severity index 1, women
    5
        Severity index 2, men
    4
        Severity index 2, women
    3
        Severity index 3, men
    0
        Severity index 3, women
    1
        Severity index 4, men
    0
        Severity index 4, women
    1
    No statistical analyses for this end point

    Secondary: Side effect, erythema, week 8

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    End point title
    		 Side effect, erythema, week 8
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    45
    Units: Number of patients
        Severity index 0, men
    5
        Severity index 0, women
    9
        Severity index 1, men
    5
        Severity index 1, women
    4
        Severity index 2, men
    10
        Severity index 2, women
    6
        Severity index 3, men
    3
        Severity index 3, women
    3
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect: Oedema, week 8

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    End point title
    		 Side effect: Oedema, week 8
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    45
    Units: Number of patients
        Severity index 0, men
    12
        Severity index 0, women
    13
        Severity index 1, men
    5
        Severity index 1, women
    6
        Severity index 2, men
    4
        Severity index 2, women
    3
        Severity index 3, men
    2
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, Blister, week 8

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    End point title
    		 Side effect, Blister, week 8
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    45
    Units: Number of patients
        Severity index 0, men
    18
        Severity index 0, women
    20
        Severity index 1, men
    3
        Severity index 1, women
    1
        Severity index 2, men
    1
        Severity index 2, women
    1
        Severity index 3, men
    1
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, Erosion, week 8

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    End point title
    		 Side effect, Erosion, week 8
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    45
    Units: Number of patients
        Severity index 0, men
    11
        Severity index 0, women
    16
        Severity index 1, men
    6
        Severity index 1, women
    1
        Severity index 2, men
    3
        Severity index 2, women
    3
        Severity index 3, men
    3
        Severity index 3, women
    2
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, encrustation, week 8

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    End point title
    		 Side effect, encrustation, week 8
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    45
    Units: Number of patients
        Severity index 0, men
    11
        Severity index 0, women
    15
        Severity index 1, men
    4
        Severity index 1, women
    2
        Severity index 2, men
    4
        Severity index 2, women
    3
        Severity index 3, men
    4
        Severity index 3, women
    1
        Severity index 4, men
    0
        Severity index 4, women
    1
    No statistical analyses for this end point

    Secondary: Side effect, Erythema, week 12

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    End point title
    		 Side effect, Erythema, week 12
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    5
        Severity index 0, women
    7
        Severity index 1, men
    10
        Severity index 1, women
    5
        Severity index 2, men
    6
        Severity index 2, women
    6
        Severity index 3, men
    4
        Severity index 3, women
    1
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, Oedema, week 12

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    End point title
    		 Side effect, Oedema, week 12
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    17
        Severity index 0, women
    14
        Severity index 1, men
    2
        Severity index 1, women
    4
        Severity index 2, men
    1
        Severity index 2, women
    1
        Severity index 3, men
    5
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, Blister, week 12

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    End point title
    		 Side effect, Blister, week 12
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    21
        Severity index 0, women
    19
        Severity index 1, men
    2
        Severity index 1, women
    0
        Severity index 2, men
    1
        Severity index 2, women
    0
        Severity index 3, men
    1
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, Erosion, week 12

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    End point title
    		 Side effect, Erosion, week 12
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    16
        Severity index 0, women
    14
        Severity index 1, men
    5
        Severity index 1, women
    3
        Severity index 2, men
    1
        Severity index 2, women
    2
        Severity index 3, men
    3
        Severity index 3, women
    0
        Severity index 4, men
    0
        Severity index 4, women
    0
    No statistical analyses for this end point

    Secondary: Side effect, encrustation, week 12

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    End point title
    		 Side effect, encrustation, week 12
    End point description
    Severity index ranges from 0 to 4, higher values indicating more severity. Side effects were documented during the study visits.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    44
    Units: Number of patients
        Severity index 0, men
    13
        Severity index 0, women
    14
        Severity index 1, men
    5
        Severity index 1, women
    4
        Severity index 2, men
    4
        Severity index 2, women
    1
        Severity index 3, men
    2
        Severity index 3, women
    0
        Severity index 4, men
    1
        Severity index 4, women
    0
    No statistical analyses for this end point

    Other pre-specified: Frequency of applications of Imiquimod, Week 1-2

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    End point title
    		 Frequency of applications of Imiquimod, Week 1-2
    End point description
    End point type
    Other pre-specified
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    53
    Units: percent
    number (not applicable)
        0-1 applications, week 1-2, men
    4
        0-1 applications, week 1-2, women
    0
        2 applications, week 1-2, men
    0
        2 applications, week 1-2, women
    0
        3 applications, week 1-2, men
    0
        3 applications, week 1-2, women
    0
        4 applications, week 1-2, men
    4
        4 applications, week 1-2, women
    14
        5 applications, week 1-2, men
    7
        5 applications, week 1-2, women
    0
        ≥ 6 applications, week 1-2, men
    85
        ≥ 6 applications, week 1-2, women
    86
    No statistical analyses for this end point

    Other pre-specified: Frequency of applications of Imiquimod, Week 3-4

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    End point title
    		 Frequency of applications of Imiquimod, Week 3-4
    End point description
    End point type
    Other pre-specified
    End point timeframe
    2 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    53
    Units: percent
    number (not applicable)
        0-1 applications, men
    0
        0-1 applications, women
    10
        2-3 applications, men
    4
        2-3 applications, women
    0
        4-5 applications, men
    4
        4-5 applications, women
    10
        6-7 applications, men
    15
        6-7 applications, women
    5
        8-9 applications, men
    12
        8-9 applications, women
    10
        10 applications, men
    65
        10 applications, women
    65
    No statistical analyses for this end point

    Other pre-specified: Frequency of applications of Imiquimod, Week 5-8

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    End point title
    		 Frequency of applications of Imiquimod, Week 5-8
    End point description
    End point type
    Other pre-specified
    End point timeframe
    3 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    53
    Units: percent
    number (not applicable)
        0-5 applications, men
    10
        0-5 applications, women
    17
        6-11 applications, men
    10
        6-11 applications, women
    9
        12-17 applications, men
    23
        12-17 applications, women
    31
        18-22 applications, men
    17
        18-22 applications, women
    13
        23-27 applications, men
    3
        23-27 applications, women
    4
        28 applications, men
    37
        28 applications, women
    26
    No statistical analyses for this end point

    Other pre-specified: Frequency of applications of Imiquimod, Week 9-12

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    End point title
    		 Frequency of applications of Imiquimod, Week 9-12
    End point description
    End point type
    Other pre-specified
    End point timeframe
    3 weeks
    End point values
    		 Imiquimod
    Number of subjects analysed
    53
    Units: percent
    number (not applicable)
        0-5 applications, men
    7
        0-5 applications, women
    23
        6-11 applications, men
    18
        6-11 applications, women
    17
        12-17 applications, men
    32
        12-17 applications, women
    13
        18-22 applications, men
    18
        18-22 applications, women
    17
        23-27 applications, men
    7
        23-27 applications, women
    4
        28 applications, men
    18
        28 applications, women
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Imiquimod
    Reporting group description
    		 -

    Serious adverse events
    		 Imiquimod
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 53 (30.19%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenocarcinoma of colon
    Additional description: Diagnosis of event and hospitalisation for treatment were documented as SAE, respectively
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasm recurrence
    Additional description: Recurrence of melanoma
         subjects affected / exposed
    4 / 53 (7.55%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Angiography
    Additional description: Hospitalisation due to Coronary angiography
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Skin and subcutaneous tissue therapeutic procedures
    Additional description: Excision of basal cell carcinoma and re-excision of recurring melanoma
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Subdural haematoma
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Basal cell carcinoma
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Purpura
    Additional description: posttraumatic purpura
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Imiquimod
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 53 (90.57%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Skin erosion
         subjects affected / exposed
    33 / 53 (62.26%)
         occurrences all number
    61
    Erythema
         subjects affected / exposed
    44 / 53 (83.02%)
         occurrences all number
    114
    Oedema
         subjects affected / exposed
    34 / 53 (64.15%)
         occurrences all number
    66
    Blister
         subjects affected / exposed
    18 / 53 (33.96%)
         occurrences all number
    24
    crust
         subjects affected / exposed
    33 / 53 (62.26%)
         occurrences all number
    59
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    3

    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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