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    Clinical Trial Results:
    A Multi-Center, Double-Blind, Randomized, Dose-Ranging Study of the Safety and Efficacy of IDP-102 Gel 5 %, and 15 % Compared with Vehicle in the Treatment of Common Warts.

    Summary
    EudraCT number
    		 2005-002820-32
    Trial protocol
    		 DE  
    Global end of trial date
    15 Aug 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    250508BS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dow Pharmaceutical Sciences, Inc.
    Sponsor organisation address
    1330 Redwood Way, Petaluma, United States, 94954-7121
    Public contact
    Project Manager, Dow Pharmaceuticals, +1 707-796-7226,
    Scientific contact
    Project Manager, Dow Pharmaceuticals, +1 707-796-7226,
    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 Aug 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Aug 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To define the optimal concentration of IDP-102 Gel 5 %, and 15 % compared to vehicle when applied to common warts, for up to 12 weeks of treatment.
    Protection of trial subjects
    The study was performed in accordance with the currently valid Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2005
    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
    Germany: 107
    Worldwide total number of subjects
    107
    EEA total number of subjects
    107
    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)
    107
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Males or females, aged 18 to 50 years; subjects must have been clinically diagnosed with at least 2 but not more than 15 common warts (non plantar and non-subungual). Flat warts were also excluded from treatment.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IDP-102 Gel 5%
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDP-102 Gel 5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically.

    Arm title
    		 IDP-102 Gel 15%
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IDP-102 Gel 15%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically.

    Arm title
    		 Vehicle Gel
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Applied topically.

    Number of subjects in period 1
    		IDP-102 Gel 5% IDP-102 Gel 15% Vehicle Gel
    Started
    37
    35
    35
    Completed
    36
    34
    33
    Not completed
    1
    1
    2
         Consent withdrawn by subject
    1
    -
    1
         Lost to follow-up
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IDP-102 Gel 5%
    Reporting group description
    		 -

    Reporting group title
    IDP-102 Gel 15%
    Reporting group description
    		 -

    Reporting group title
    Vehicle Gel
    Reporting group description
    		 -

    Reporting group values
    		 IDP-102 Gel 5% IDP-102 Gel 15% Vehicle Gel Total
    Number of subjects
    		 37 35 35 107
    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 (standard deviation)
    		 34.41 ± 11.23 35.46 ± 13.14 33.74 ± 13.07 -
    Gender categorical
    Units: Subjects
        Female
    		 15 15 9 39
        Male
    		 22 20 26 68
    Wart count
    Units: wart
        arithmetic mean (standard deviation)
    		 5.03 ± 3.387 5.14 ± 3.228 4.76 ± 3.153 -

    End points

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    End points reporting groups
    Reporting group title
    IDP-102 Gel 5%
    Reporting group description
    		 -

    Reporting group title
    IDP-102 Gel 15%
    Reporting group description
    		 -

    Reporting group title
    Vehicle Gel
    Reporting group description
    		 -

    Primary: Change from baseline in wart count

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    End point title
    		 Change from baseline in wart count [1]
    End point description
    End point type
    Primary
    End point timeframe
    84 days
    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 comparisons were conducted between treatment groups.
    End point values
    		 IDP-102 Gel 5% IDP-102 Gel 15% Vehicle Gel
    Number of subjects analysed
    37
    35
    34
    Units: warts
        arithmetic mean (standard deviation)
    0.57 ± 1.879
    0.71 ± 1.824
    0.26 ± 0.567
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    84 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    IDP-102 Gel 5%
    Reporting group description
    		 -

    Reporting group title
    IDP-102 Gel 15%
    Reporting group description
    		 -

    Reporting group title
    Vehicle Gel
    Reporting group description
    		 -

    Serious adverse events
    		 IDP-102 Gel 5% IDP-102 Gel 15% Vehicle Gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IDP-102 Gel 5% IDP-102 Gel 15% Vehicle Gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 37 (72.97%)
    26 / 35 (74.29%)
    14 / 34 (41.18%)
    Investigations
    Increased GOT
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    0
    1
    Increased triglycerides
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
         occurrences all number
    2
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 35 (8.57%)
    3 / 34 (8.82%)
         occurrences all number
    2
    3
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 35 (2.86%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    2
    Infections and infestations
    Cold
         subjects affected / exposed
    10 / 37 (27.03%)
    5 / 35 (14.29%)
    5 / 34 (14.71%)
         occurrences all number
    10
    5
    6
    Hay fever
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 35 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2005
    Considering the fact that no sufficient data on reproductive toxicity are available, BfArM requested to change the wording with regards to acceptable methods of contraception to increase the safety of the patients.

    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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