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    Clinical Trial Results:
    Safety and efficacy of repeat use of Picato® 0.05% in the treatment of anogenital warts

    Summary
    EudraCT number
    		 2014-004465-24
    Trial protocol
    		 DK  
    Global end of trial date
    26 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Dec 2016
    First version publication date
    08 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EXP-1167
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02377999
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 45 44945888, ctr.disclosure@leo-pharma.com
    Scientific contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 45 44945888, ctr.disclosure@leo-pharma.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
    15 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of single treatment with Picato® 0.05% repeated up to 2 times with two weeks intervals in subjects with anogenital warts.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 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
    Denmark: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    39
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 41 subjects were enrolled in the trial, 1 subject was a screening failure, and 40 subjects were assigned treatment with ingenol mebutate gel 0.05%. All subjects were enrolled at a single site in Denmark.

    Pre-assignment
    Screening details
    		 A screening visit was conducted up to 7 days before start of treatment to screen for eligibility, to obtain informed consent, and collect demographic and baseline data.

    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
    		 All subjects
    Arm description
    		 Of the 40 subjects assigned treatment, 22 subjects (55%) received 1 dose of ingenol mebutate gel 0.05%, 8 subjects (20%) received 2 doses and 10 subjects (25%) received 3 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ingenol mebutate gel 0.05%
    Investigational medicinal product code
    Other name
    Picato® gel 0.05%
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Ingenol mebutate gel 0.05% was applied to the genital wart on Day 1 and if complete clearance of the genital wart was not obtained on Day 15, ingenol mebutate gel 0.05% was to be applied again on Day 15 and Day 29, as applicable. The applications were done at the trial site by the (sub)investigator. Any hair on the treatment area was cut with scissors to a length of maximum 2-3 mm. Picato® gel was applied in a generous amount, covering the genital wart in a thick layer and also covering 1-2 mm of the normal skin surrounding the wart.

    Number of subjects in period 1 [1]
    		All subjects
    Started
    40
    Completed
    26
    Not completed
    14
         Adverse event, non-fatal
    5
         Lost to follow-up
    2
         Unacceptable Local Skin Reaction (LSR)
    5
         Lack of efficacy
    2
    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: 1 enrolled subject was a screening failure and was not assigned to treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Of the 40 subjects assigned treatment, 22 subjects (55%) received 1 dose of ingenol mebutate gel 0.05%, 8 subjects (20%) received 2 doses and 10 subjects (25%) received 3 doses.

    Reporting group values
    		 All subjects Total
    Number of subjects
    		 40 40
    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)
    		 38 38
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 33 33

    End points

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    End points reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Of the 40 subjects assigned treatment, 22 subjects (55%) received 1 dose of ingenol mebutate gel 0.05%, 8 subjects (20%) received 2 doses and 10 subjects (25%) received 3 doses.

    Subject analysis set title
    Subjects receiving 1 dose
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received 1 dose of IMP.

    Subject analysis set title
    Subjects receiving 2 doses
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received 2 doses of IMP.

    Subject analysis set title
    Subjects receiving 3 doses
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who received 3 doses of IMP.

    Subject analysis set title
    Day 15
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who were assessed on Day 15/Visit 4.

    Subject analysis set title
    Day 29
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who were assessed on Day 29/Visit 5.

    Subject analysis set title
    Day 43
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who were assessed on Day 43/Visit 6.

    Subject analysis set title
    Follow-up
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects who were assessed at follow-up visit - 12 weeks after Day 29 or Day 43.

    Primary: Safety and tolerability - Day of Maximum Composite Local Skin Reaction (LSR) score by number of doses

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    End point title
    		 Safety and tolerability - Day of Maximum Composite Local Skin Reaction (LSR) score by number of doses [1]
    End point description
    The primary endpoint of this trial was incidence and severity of LSRs and treatment related AEs, assessed by: -Day of Maximum Composite LSR score by number of doses -Maximum Composite LSR score across visits -Maximum Composite LSR score across visits by treated area LSRs were assessed for presence/absence and grade (0 to 3) of the following individual LSRs: erythema, edema, weeping/exudate, vesiculation/blistering, crusting/(scabbing), and erosion/ulceration. A composite LSR score (0 to 18), reflecting the sum of the individual LSR components, was calculated at each visit.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 43
    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: As this was an exploratory trial, no statistical analysis was planned.
    End point values
    		 Subjects receiving 1 dose Subjects receiving 2 doses Subjects receiving 3 doses
    Number of subjects analysed
    22
    8
    10
    Units: Subjects
        Day 3/Visit 3
    22
    8
    9
        Day 29/Visit 5
    0
    0
    1
    No statistical analyses for this end point

    Primary: Safety and tolerability - Maximum Composite Local Skin Reaction (LSR) score across visits by number of doses

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    End point title
    		 Safety and tolerability - Maximum Composite Local Skin Reaction (LSR) score across visits by number of doses [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to Day 43
    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: As this was an exploratory trial, no statistical analysis was planned.
    End point values
    		 All subjects Subjects receiving 1 dose Subjects receiving 2 doses Subjects receiving 3 doses
    Number of subjects analysed
    40
    22
    8
    10
    Units: NA
    arithmetic mean (standard deviation)
        Maximum Composite LSR score
    8.2 ( 3.4 )
    8.5 ( 3.6 )
    9 ( 3.7 )
    7.1 ( 3 )
    No statistical analyses for this end point

    Primary: Safety and tolerability - Maximum Composite Local Skin Reaction (LSR) score across visits by treated area

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    End point title
    		 Safety and tolerability - Maximum Composite Local Skin Reaction (LSR) score across visits by treated area [3]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to Day 43
    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: As this was an exploratory trial, no statistical analysis was planned.
    End point values
    		 All subjects
    Number of subjects analysed
    40 [4]
    Units: NA
    arithmetic mean (standard deviation)
        Foreskin (n=11)
    10.3 ( 3.2 )
        Glans penis (n=2)
    10 ( 2.8 )
        Penis shaft (n=19)
    7.4 ( 2.4 )
        Perianal (n=7)
    6.3 ( 1.3 )
        Perineal (n=3)
    9.3 ( 4.2 )
        Scrotum (n=7)
    9.3 ( 4.2 )
        Vulva (n=4)
    8.3 ( 5.7 )
        Total (n=53)
    8.4 ( 3.3 )
    Notes
    [4] - 40 subjects with a total of 53 (n=53) treated areas
    No statistical analyses for this end point

    Secondary: Complete Clearance of Anogenital Warts 14 Days after Last Treatment Application

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    End point title
    		 Complete Clearance of Anogenital Warts 14 Days after Last Treatment Application
    End point description
    Complete clearance of anogenital warts after end of trial (defined as 14 days after last treatment application) and by visits.
    End point type
    Secondary
    End point timeframe
    14 Days after last treatment application
    End point values
    		 All subjects Day 15 Day 29 Day 43 Follow-up
    Number of subjects analysed
    39 [5]
    38
    33
    17
    16
    Units: Subjects
        Subjects cleared
    17
    12
    11
    4
    6
        Subjects not cleared
    22
    26
    22
    13
    10
    Notes
    [5] - Assessment was missing for 1 subject withdrawn at visit 3
    No statistical analyses for this end point

    Secondary: Percentage Reduction in Anogenital Wart Count from Baseline to End of Trial

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    End point title
    		 Percentage Reduction in Anogenital Wart Count from Baseline to End of Trial
    End point description
    Percentage reduction in anogenital wart count from baseline to end of trial (defined as 14 days after last treatment application) and by visit. ‘End of trial’ measure was defined as occurring 14 days after last treatment application.
    End point type
    Secondary
    End point timeframe
    Day 1 to End of Trial
    End point values
    		 All subjects Day 15 Day 29 Day 43 Follow-up
    Number of subjects analysed
    40
    38
    33
    17
    16
    Units: percent
    arithmetic mean (standard deviation)
        Subject level
    80.7 ( 25.5 )
    71.4 ( 31 )
    69.4 ( 30.8 )
    66.5 ( 30.9 )
    61.5 ( 48.6 )
    No statistical analyses for this end point

    Secondary: Recurrence Rate - subject level

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    End point title
    		 Recurrence Rate - subject level
    End point description
    Recurrence of genital warts was assessed 12 weeks after Day 29 or Day 43 for subjects with complete clearance at any previous visit. Reporting group: 16 subjects had complete clearance at the last visit, but 2 subjects did not attend the follow-up visit and were not assessed for recurrence. 8 out of 14 subjects (57.1%) had recurrence.
    End point type
    Secondary
    End point timeframe
    12 weeks after Day 29 or Day 43
    End point values
    		 All subjects
    Number of subjects analysed
    16 [6]
    Units: percent
    arithmetic mean (confidence interval 95%)
        Recurrence
    57.1 (28.9 to 82.3)
    Notes
    [6] - 16 subjects subjects had complete clearance at the last visit.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to the end of follow-up after final treatment (12 weeks from Day 29 or Day 43)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 40 (95.00%)
    Injury, poisoning and procedural complications
    Procedural complication
         subjects affected / exposed
    14 / 40 (35.00%)
         occurrences all number
    15
    Skin injury
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Tendon injury
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    34 / 40 (85.00%)
         occurrences all number
    39
    Application site pruritus
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Application site reaction
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Application site discolouration
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Application site induration
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hunger
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Inflammation
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Application site infection
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    1 / 40 (2.50%)
         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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