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

    Summary
    EudraCT number
    		 2010-024428-10
    Trial protocol
    		 FR  
    Global end of trial date
    06 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions
    Summary report(s)
    		 end study
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    10-PP-19
    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
    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)
    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
    06 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2014
    Was the trial ended prematurely?
    No
    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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    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
    		 -

    Pre-assignment
    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?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Oral erythromycin therapy
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    erythromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    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
    Started
    5
    Completed
    5

    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
    Primary
    End point timeframe
    At baseline, after 1 month and 3 months of treatment
    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: The description is in the arcticle
    End point values
    		 Oral erythromycin therapy
    Number of subjects analysed
    5
    Units: NA
    5
    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
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Frequency threshold for reporting non-serious adverse events: 5%
    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 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
    Date
    Amendment
    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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