Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, vehicle controlled, active comparator, parallel group study to evaluate safety, tolerability and preliminary efficacy of topical LFX453 formulations in patients with actinic keratosis

    Summary
    EudraCT number
    		 2014-003613-28
    Trial protocol
    		 AT   IS   DE   DK   GB  
    Global end of trial date
    27 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2017
    First version publication date
    12 Feb 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLFX453X2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02404389
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study were i) to assess tolerability and safety of LFX453 in patients with actinic keratosis (AK) and ii) to assess efficacy of LFX453 compared to vehicle in patients with actinic keratosis.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2015
    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: 6
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    Germany: 41
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Iceland: 19
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    18
    From 65 to 84 years
    64
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 82 patients, male and female of non-childbearing potential aged 18-75 years, with Actinic Keratosis (AK) on the face or balding scalp were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LFX453 0.1% NMC
    Arm description
    		 LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications
    Arm type
    		 Experimental

    Investigational medicinal product name
    LFX453
    Investigational medicinal product code
    LFX453
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    LFX453 nanomedicinal cream (NMC) 0.1% apply twice daily topically

    Arm title
    		 LFX453 0.15% LCC
    Arm description
    		 LFX453 0.15% liquid crystal cream (LCC) Twice daily applications
    Arm type
    		 Experimental

    Investigational medicinal product name
    LFX453
    Investigational medicinal product code
    LFX453
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    LFX453 liquid crystal cream (LCC) 0.15% apply twice daily topically

    Arm title
    		 Vehicle to NMC
    Arm description
    		 Vehicle to nanomedicinal cream (NMC) Twice daily applications
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    LFX453
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    vehicle to nanomedicinal cream (NMC) apply twice daily topically

    Arm title
    		 Vehicle to LCC
    Arm description
    		 Vehicle to liquid crystal cream (LCC) Twice daily applications
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    LFX453
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    vehicle to liquid crystal cream (LCC) apply twice daily topically

    Arm title
    		 Aldara
    Arm description
    		 Aldara cream 3 applications per week
    Arm type
    		 Active comparator

    Investigational medicinal product name
    imiquimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Aldara® 5% cream apply 3 days per week topically

    Number of subjects in period 1
    		LFX453 0.1% NMC LFX453 0.15% LCC Vehicle to NMC Vehicle to LCC Aldara
    Started
    20
    20
    11
    10
    21
    Completed
    18
    20
    10
    9
    18
    Not completed
    2
    0
    1
    1
    3
         Adverse event, non-fatal
    1
    -
    1
    -
    2
         Subject/guardian decision
    1
    -
    -
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    LFX453 0.1% NMC
    Reporting group description
    		 LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications

    Reporting group title
    LFX453 0.15% LCC
    Reporting group description
    		 LFX453 0.15% liquid crystal cream (LCC) Twice daily applications

    Reporting group title
    Vehicle to NMC
    Reporting group description
    		 Vehicle to nanomedicinal cream (NMC) Twice daily applications

    Reporting group title
    Vehicle to LCC
    Reporting group description
    		 Vehicle to liquid crystal cream (LCC) Twice daily applications

    Reporting group title
    Aldara
    Reporting group description
    		 Aldara cream 3 applications per week

    Reporting group values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Vehicle to NMC Vehicle to LCC Aldara Total
    Number of subjects
    		 20 20 11 10 21 82
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 7 4 2 1 4 18
        From 65-84 years
    		 13 16 9 9 17 64
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.7 ± 5.23 68.6 ± 6.25 68.3 ± 6.66 70.2 ± 4.32 68.6 ± 5.61 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 5 2 0 2 0 9
        Male
    		 15 18 11 8 21 73
    Subject analysis sets

    Subject analysis set title
    Combined Vehicle
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications

    Subject analysis sets values
    		 Combined Vehicle
    Number of subjects
    21
    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)
    3
        From 65-84 years
    18
        85 years and over
    0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    Gender, Male/Female
    Units: Subjects
        Female
    2
        Male
    19

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    LFX453 0.1% NMC
    Reporting group description
    		 LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications

    Reporting group title
    LFX453 0.15% LCC
    Reporting group description
    		 LFX453 0.15% liquid crystal cream (LCC) Twice daily applications

    Reporting group title
    Vehicle to NMC
    Reporting group description
    		 Vehicle to nanomedicinal cream (NMC) Twice daily applications

    Reporting group title
    Vehicle to LCC
    Reporting group description
    		 Vehicle to liquid crystal cream (LCC) Twice daily applications

    Reporting group title
    Aldara
    Reporting group description
    		 Aldara cream 3 applications per week

    Subject analysis set title
    Combined Vehicle
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications

    Primary: Number of adverse events (AE)/Serious Adverse Events (SAE) as a measure of safety and tolerability up to 20 weeks

    		 Close Top of page
    End point title
    		 Number of adverse events (AE)/Serious Adverse Events (SAE) as a measure of safety and tolerability up to 20 weeks [1]
    End point description
    Number of participants with at least one AE/SAE in the category up to 20 weeks
    End point type
    Primary
    End point timeframe
    20 weeks
    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 was planned for this primary outcome.
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Vehicle to NMC Vehicle to LCC Aldara
    Number of subjects analysed
    20
    20
    11
    10
    21
    Units: participants
        Adverse Events (AEs)
    10
    15
    9
    8
    18
        Serious Adverse Events (SAEs)
    1
    1
    1
    1
    1
    No statistical analyses for this end point

    Primary: Number of Participants that had Complete clearance of Actinic keratosis (AK) at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

    		 Close Top of page
    End point title
    		 Number of Participants that had Complete clearance of Actinic keratosis (AK) at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined [2]
    End point description
    Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
    End point type
    Primary
    End point timeframe
    Week 20
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point was provided for the arms that were part of this objective and not all baseline period arms
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Combined Vehicle
    Number of subjects analysed
    20
    20
    21
    Units: participants
    1
    1
    1
    Statistical analysis title
    		 LFX453 0.1% NMC versus Combined Vehicle
    Comparison groups
    LFX453 0.1% NMC v Combined Vehicle
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.515
    Method
    		 Posterior mean
    Parameter type
    		 Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.12
    Variability estimate
    Standard deviation
    Dispersion value
    0.07
    Notes
    [3] - There was no difference in the posterior mean in the complete clearance rate between LFX453 NMC and the combined vehicle group, since the posterior distribution for the difference in complete clearance rate did not reach a 90% chance of being positive (probability =0.515).
    Statistical analysis title
    		 LFX453 0.15% LCC versus Combined Vehicle
    Comparison groups
    LFX453 0.15% LCC v Combined Vehicle
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    P-value
    		 = 0.517
    Method
    		 posterior mean
    Parameter type
    		 Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.13
    Variability estimate
    Standard deviation
    Dispersion value
    0.07
    Notes
    [4] - There was no difference in the posterior mean in the complete clearance rate between LFX453 LCC and the combined vehicle group, since the posterior distribution for the difference in complete clearance rate did not reach a 90% chance of being positive (probability =0.517).

    Primary: Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

    		 Close Top of page
    End point title
    		 Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined [5] [6]
    End point description
    Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
    End point type
    Primary
    End point timeframe
    Week 20
    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: No statistical analysis was planned for this primary outcome.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point was provided for the arms that were part of this objective and not all baseline period arms
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Combined Vehicle
    Number of subjects analysed
    20
    20
    21
    Units: lesion count
        arithmetic mean (standard deviation)
    33.2 ± 31.19
    34.5 ± 33.2
    34.3 ± 33.31
    No statistical analyses for this end point

    Secondary: Number of Participants that had Complete clearance of Actinic keratosis (AK) at Week 8 and Week 16 for LFX453 compared to vehicle groups combined

    		 Close Top of page
    End point title
    		 Number of Participants that had Complete clearance of Actinic keratosis (AK) at Week 8 and Week 16 for LFX453 compared to vehicle groups combined [7]
    End point description
    Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
    End point type
    Secondary
    End point timeframe
    week 8, week 16
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point was provided for the arms that were part of this objective and not all baseline period arms
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Combined Vehicle
    Number of subjects analysed
    20
    20
    21
    Units: participants
        Week 8
    0
    0
    1
        Week 16
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Participants that had Partial clearance of Actinic keratosis (AK) at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

    		 Close Top of page
    End point title
    		 Number of Participants that had Partial clearance of Actinic keratosis (AK) at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined [8]
    End point description
    Partial clearance of Actinic keratosis (AK), the defined as proportion of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point was provided for the arms that were part of this objective and not all baseline period arms
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Combined Vehicle
    Number of subjects analysed
    20
    20
    21
    Units: participants
    1
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Participants that Partial clearance of Actinic keratosis (AK) at at Week 8 and Week 16 for LFX453 compared to vehicle groups combined

    		 Close Top of page
    End point title
    		 Number of Participants that Partial clearance of Actinic keratosis (AK) at at Week 8 and Week 16 for LFX453 compared to vehicle groups combined [9]
    End point description
    Partial clearance of Actinic keratosis (AK), the defined as proportion of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
    End point type
    Secondary
    End point timeframe
    week 8, week 16
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point was provided for the arms that were part of this objective and not all baseline period arms
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Combined Vehicle
    Number of subjects analysed
    20
    20
    21
    Units: participants
        Week 8
    1
    0
    3
        Week 16
    3
    4
    3
    No statistical analyses for this end point

    Secondary: Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined

    		 Close Top of page
    End point title
    		 Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined [10]
    End point description
    Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined
    End point type
    Secondary
    End point timeframe
    Week 8
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point was provided for the arms that were part of this objective and not all baseline period arms
    End point values
    		 LFX453 0.1% NMC LFX453 0.15% LCC Combined Vehicle
    Number of subjects analysed
    20
    20
    21
    Units: lesion count
        arithmetic mean (standard deviation)
    21.9 ± 36.18
    21.9 ± 28.91
    32.3 ± 33.55
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    LFX453 0.1% NMC
    Reporting group description
    		 LFX453 0.1% NMC

    Reporting group title
    LFX453 0.15% LCC
    Reporting group description
    		 LFX453 0.15% LCC

    Reporting group title
    Vehicle NMC
    Reporting group description
    		 Vehicle NMC

    Reporting group title
    Vehicle LCC
    Reporting group description
    		 Vehicle LCC

    Reporting group title
    Aldara
    Reporting group description
    		 Aldara

    Serious adverse events
    		 LFX453 0.1% NMC LFX453 0.15% LCC Vehicle NMC Vehicle LCC Aldara
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBRAL INFARCTION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL HERNIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 LFX453 0.1% NMC LFX453 0.15% LCC Vehicle NMC Vehicle LCC Aldara
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 20 (50.00%)
    14 / 20 (70.00%)
    9 / 11 (81.82%)
    8 / 10 (80.00%)
    17 / 21 (80.95%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    2
    SEBORRHOEIC KERATOSIS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vascular disorders
    HAEMATOMA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    1
    HYPERTENSION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    THROMBOSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    APPLICATION SITE COLDNESS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    APPLICATION SITE ERYTHEMA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    5 / 21 (23.81%)
         occurrences all number
    0
    0
    0
    0
    6
    APPLICATION SITE PRURITUS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    1
    2
    APPLICATION SITE SCAB
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    3
    CHILLS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    1
    FATIGUE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    0
    2
    HYPOTHERMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    0
    0
    0
    3
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    1
    RHINITIS ALLERGIC
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Psychiatric disorders
    AGITATION
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    BURNOUT SYNDROME
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    ANTIPSYCHOTIC DRUG LEVEL INCREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    1
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    CORNEAL ABRASION
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    EYELID INJURY
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    HEAD INJURY
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    1
    1
    LACERATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    MUSCLE RUPTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    PERIORBITAL HAEMATOMA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    RIB FRACTURE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    AUTONOMIC NERVOUS SYSTEM IMBALANCE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    BURNING SENSATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    DIZZINESS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    1
    HEADACHE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    2
    0
    2
    POLYNEUROPATHY
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    POOR QUALITY SLEEP
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    SCIATICA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    HAEMOLYTIC ANAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    INCREASED TENDENCY TO BRUISE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    VESTIBULAR DISORDER
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye disorders
    BLEPHARITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    APHTHOUS ULCER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    APICAL GRANULOMA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    DIARRHOEA
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    NAUSEA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    1
    TOOTHACHE
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    BLISTER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    DRY SKIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    ECZEMA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    ERYTHEMA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    1
    PAIN OF SKIN
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    SKIN EXFOLIATION
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    1
    Renal and urinary disorders
    RENAL CYST
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    0
    1
    BACK PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    MYALGIA
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    MYOSCLEROSIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    NECK PAIN
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    OSTEOARTHRITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    PERIARTHRITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    CYSTITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    EYE INFECTION
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    INFLUENZA
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 20 (25.00%)
    3 / 11 (27.27%)
    1 / 10 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    6
    3
    1
    1
    ORAL HERPES
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    PNEUMONIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    RELAPSING FEVER
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    1
    SINUSITIS
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    TINEA PEDIS
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    HYPOKALAEMIA
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2014
    Amendment 1 (issued before patient enrollment started) was generated as a result of a change in the storage conditions of the study drug.The major change to the protocol was the description of study drug handling when administered to the patient in Protocol Section 3.1. Minor typos were corrected and imiquimod 5% cream specified to Aldara® to reflect actual plans. The changes included in this amendment did not influence the population or design of the study.
    27 Jan 2015
    Amendment 2 was generated to implement requests received from Health Authorities (HAs) and ethics committees (ECs) primarily to repeat pregnancy tests throughout the treatment period of the study, ensure that patients included were not under any influence from study staff, and included information to instruct patients to minimize exposure of the treated areas to UV light or sunlight. The changes included in this amendment did not influence the patient safety or scientific value of this study. The amendment was considered to be non-substantial.
    15 Sep 2015
    Amendment 3 was developed to clarify the analyses time point considered for the interim and final analysis of the primary and secondary endpoints given the fact that patients could achieve complete clearance already at the end of the first of 4-week treatment. The specific length of treatment duration (2 cycles of 4-week treatment) was removed to allow patients with complete clearance after one treatment cycle to be included in the analysis. The opportunity was also taken to clarify the exclusion criterion #7 and the location of biopsies. The frequent association of Bowen’s disease in these patients was not foreseen and therefore could constitute an exclusion criterion based on the previous wording of exclusion criterion #7. The exclusion criterion #7 was revised to clarify that patients with Bowen’s disease shall not be excluded, similarly to patients with basal cell carcinoma of the skin or in-situ cervical cancer. The changes described in this amended protocol were substantial and required IRB/IEC approval prior to implementation. In addition, if the changes herein affected the Informed Consent, sites were required to update and submit for approval a revised Informed Consent that took into account the changes described in this amended protocol. These amendments were not considered to have affected the interpretation of study results as they were minor and occurred prior to study unblinding.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 20 06:06:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA