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    Clinical Trial Results:
    Traitement des épidermolyses bulleuses simples de type Dowling Maera par l'érythromicine orale

    EudraCT number
    Trial protocol
    Global end of trial date
    06 Aug 2014

    Results information
    Results version number
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions
    Summary report(s)
    end study

    Trial information

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    Trial identification
    Sponsor protocol code
    Additional study identifiers
    ISRCTN number
    US NCT number
    WHO universal trial number (UTN)
    Sponsor organisation name
    chu de nice
    Sponsor organisation address
    DRCI-Hôpital de Cimiez - 4 avenue reine victoria, Nice, France, 06003
    Public contact
    Directeur de la Recherche clinique, CHU de nice - DRCI, +33 492034011, caillon.c@chu-nice.fr
    Scientific contact
    Investigateur Principal, CHU de Nice - DR Chiaverini, +33 492036488, chiaverini.c@chu-nice.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Results analysis stage
    Analysis stage
    Date of interim/final analysis
    06 Aug 2014
    Is this the analysis of the primary completion data?
    Primary completion date
    06 Aug 2014
    Global end of trial reached?
    Global end of trial date
    06 Aug 2014
    Was the trial ended prematurely?
    General information about the trial
    Main objective of the trial
    The main objective is to estimate the efficiency of the oral érythromycine to decrease the number of cutaneous bubbles at the patients affected by EBS-DM after 3 months of treatment.
    Protection of trial subjects
    Patients of both sexes, aged 1–8 years who had EBS-gen-sev with at least two new blisters per day were eligible for the study. The parents signed the consent for the clidrens'participation.
    Background therapy
    Evidence for comparator
    Actual start date of recruitment
    29 Jun 2011
    Long term follow-up planned
    Independent data monitoring committee (IDMC) involvement?
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 5
    Worldwide total number of subjects
    EEA total number of subjects
    Number of subjects enrolled per age group
    In utero
    Preterm newborn - gestational age < 37 wk
    Newborns (0-27 days)
    Infants and toddlers (28 days-23 months)
    Children (2-11 years)
    Adolescents (12-17 years)
    Adults (18-64 years)
    From 65 to 84 years
    85 years and over

    Subject disposition

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    Recruitment details

    Screening details
    At baseline, after 1 month and 3 months of treatment, the patients were seen for body examination, questionnaire, photographs, blood tests and bacteriological swabs. Itch severity and skin fragility were evaluated by parents on a visual analogue scale. At 5 months, we asked all parents for their opinion regarding the tolerability and efficacy

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

    Arm title
    Oral erythromycin therapy
    Arm description
    Arm type

    Investigational medicinal product name
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Routes of administration
    Buccal use
    Dosage and administration details
    . A weight-based dosage was calculated for the children (< 10 kg, 250 mg per day; 10–15 kg, 500 mg per day; 15–25 kg, 750 mg per day; 25–35 kg, 1000 mg per day).

    Number of subjects in period 1
    Oral erythromycin therapy

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Oral erythromycin therapy
    Reporting group description

    Primary: The efficacy of treatment evaluate by parents

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    End point title
    The efficacy of treatment evaluate by parents [1]
    End point description
    End point type
    End point timeframe
    At baseline, after 1 month and 3 months of treatment
    [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: The description is in the arcticle
    End point values
    Oral erythromycin therapy
    Number of subjects analysed
    Units: NA
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At baseline, after 1 month and 3 months of treatment
    Assessment type
    Dictionary used for adverse event reporting
    Dictionary name
    Dictionary version
    Frequency threshold for reporting non-serious adverse events: 5%
    [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 is no adverse serious event

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    07 Jul 2011
    Increase in upper age limit
    07 Jul 2011
    modification of the route of administration of the medicinal product

    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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