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    Clinical Trial Results:
    Traitment of recessive nonbullous congenital ichthyosis with topic Epigallocatechin.

    Summary
    EudraCT number
    		 2009-013656-77
    Trial protocol
    		 FR  
    Global end of trial date
    25 Mar 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Aug 2022
    First version publication date
    14 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    09-PP-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    chu de nice
    Sponsor organisation address
    DRCI-Hôpital de Cimiez - 4 avenue reine victoria, Nice, France, 06003
    Public contact
    Christine Chiaverini, CHU de Nice Dermatolgy, chiaverini.c@chu-nice.fr
    Scientific contact
    Christine Chiaverini, CHU de Nice Dermatolgy, chiaverini.c@chu-nice.fr
    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
    25 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal objective of this trial is the evaluation of the topic Polyphenon E(R) efficacity in order to ameliorate the skin desquamation and the skin roughness in lamellar ichthysosis patients after 4 weeks of traitment.
    Protection of trial subjects
    Patients of both sexes of at least 8 years with a clinical diagnosis of lamellar ichthyosis and scores of roughness and desquamation of intensity moderated in severe on every side of the body after the obtaining informed consent from parents
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2010
    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
    France: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 6 patients with lamellar ichthyosis will be included in the trial. After selection, they will be seen in inclusion visit. After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independe

    Pre-assignment
    Screening details
    		 - Patients of both sexes of at least 8 years and less than 65 years. - Patients with a clinical diagnosis of LI

    Pre-assignment period milestones
    Number of subjects started
    		 6
    Number of subjects completed
    		 6

    Period 1
    Period 1 title
    Inclusion Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 After selection, they will be seen in inclusion visit. After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VEREGEN 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Apply about an 0.5 cm strand of the Veregen® to each wart using the finger(s) during 8 weeks

    Number of subjects in period 1
    		Treatment
    Started
    6
    Completed
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inclusion Period
    Reporting group description
    		 -

    Reporting group values
    		 Inclusion Period Total
    Number of subjects
    		 6 6
    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)
    		 6 6
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 After selection, they will be seen in inclusion visit. After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.

    Primary: patients' rate with a decrease of roughness and cutaneous desquamation score of at least 2 points at the end of the treatment (4 weeks).

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    End point title
    		 patients' rate with a decrease of roughness and cutaneous desquamation score of at least 2 points at the end of the treatment (4 weeks). [1]
    End point description
    End point type
    Primary
    End point timeframe
    After traitement : one time
    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: Patients of this trial will be analyzed in intention to treat (ITT), every patient will be analyzed according to the results of the randomisation whatever is the effectively treated zone and the therapeutic observance. An analysis per protocol will be also realized whose results will not substitute themselves for the results of the analysis in ITT. We remind that considering the gravity of this pathology, the absence of effective treatment and the hoped implication by patient's associations, num
    End point values
    		 Treatment
    Number of subjects analysed
    6
    Units: Number
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Eache visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non -serious events

    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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