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    Clinical Trial Results:
    Emollients in the management of atopic dermatitis in children: prevention of flares.

    Summary
    EudraCT number
    		 2012-004621-24
    Trial protocol
    		 LT   EE   PL   FR  
    Global end of trial date
    12 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2016
    First version publication date
    21 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V00034CR3131B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01779258
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Medicament
    Sponsor organisation address
    45, Place Abel Gance, Boulogne, France, 92100
    Public contact
    Medical and/or Clinical Study Manager, PIERRE FABRE MEDICAMENT, contact_essais_cliniques@pierre-fabre.com
    Scientific contact
    Medical and/or Clinical Study Manager, PIERRE FABRE MEDICAMENT, contact_essais_cliniques@pierre-fabre.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the ability of V0034CR to prevent flares after treatment of a previous flare by a topical corticosteroid.
    Protection of trial subjects
    Medical and clinical examination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Feb 2013
    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
    Poland: 81
    Country: Number of subjects enrolled
    Estonia: 82
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Lithuania: 95
    Country: Number of subjects enrolled
    Romania: 87
    Worldwide total number of subjects
    347
    EEA total number of subjects
    347
    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)
    347
    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
    		 347 patients were screened and 335 were randomised.

    Pre-assignment
    Screening details
    		 Patients were recruited during a flare, treated by a topical corticosteroid (run-in period Day-21 to Day0 - please see pre-assignment period), and randomised only when inflammatory lesions had cleared (treatment period). So, only 335 patients were randomised to one of the 3 groups (V0034CR01B or Atopiclair® or No emollient treatment).

    Pre-assignment period milestones
    Number of subjects started
    		 347
    Number of subjects completed
    		 335

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Non respect of eligibility criteria: 7
    Reason: Number of subjects
    		 Technical problem with IVRS: 1
    Reason: Number of subjects
    		 Eligibility criteria and parent's decision: 2
    Reason: Number of subjects
    		 Parent's or guardian's decision:consent withdrawal: 2
    Period 1
    Period 1 title
    Treatment period (Day 1 to Day 84) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexeryl®
    Investigational medicinal product code
    V0034CR01B
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    One application bid (morning and evening) on the whole body including face. During flares, the product was applied once a day (in the morning), and Locapred® was applied only to the lesions, once a day (in the evening).

    Arm title
    		 Active control group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atopiclair®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    One application tid (morning, afternoon and evening) on areas of skin affected by atopic dermatitis (AD), that had been affected by AD in the past or could reasonbly be affected by AD during the course of the study. During flares, the product was applied twice a day (in the morning and in the afternoon), and Locapred®was applied only to the lesions, once a day (in the evening).

    Arm title
    		 Reference group (no treatment)
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Experimental Group Active control group Reference group (no treatment)
    Started
    111
    116
    108
    Completed
    110
    111
    95
    Not completed
    1
    5
    13
         Efficacy concerns
    -
    4
    5
         Bad compliance
    -
    -
    1
         Parental demotivation to continue
    -
    1
    -
         Parent's decision
    -
    -
    7
         Family divorce
    1
    -
    -
    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: Following the run-in period, only 335 patients were randomised to one of the 3 groups (V0034CR or Atopiclair® or No emollient treatment) (1:1:1 ratio).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Reporting group title
    Active control group
    Reporting group description
    		 -

    Reporting group title
    Reference group (no treatment)
    Reporting group description
    		 -

    Reporting group values
    		 Experimental Group Active control group Reference group (no treatment) Total
    Number of subjects
    		 111 116 108 335
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 111 116 108 335
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 4.16 (2.1 to 6.8) 4.02 (2 to 6.7) 4.06 (2 to 6.9) -
    Gender categorical
    Units: Subjects
        Female
    		 69 51 54 174
        Male
    		 42 65 54 161
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Composed of all randomised patients, which consisted of all included patients who were assigned to a study group ( experimental group, active control group or reference group) used to perform all the analyses of efficacy and safety.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    335
    Age categorical
    Units: Subjects
        Children (2-11 years)
    335
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    4.08 (2 to 6.9)
    Gender categorical
    Units: Subjects
        Female
    174
        Male
    161

    End points

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    End points reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Reporting group title
    Active control group
    Reporting group description
    		 -

    Reporting group title
    Reference group (no treatment)
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Composed of all randomised patients, which consisted of all included patients who were assigned to a study group ( experimental group, active control group or reference group) used to perform all the analyses of efficacy and safety.

    Primary: Number of patients with at least one flare

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    End point title
    		 Number of patients with at least one flare [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Day 84.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per protocole, Primary Efficacy Analysis was only between treatment group (V0034CR01B) and reference group (no emollient).
    End point values
    		 Experimental Group Reference group (no treatment)
    Number of subjects analysed
    111
    108
    Units: patients
    39
    73
    Statistical analysis title
    		 Percentage of patients with at least one flare
    Comparison groups
    Experimental Group v Reference group (no treatment)
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Reporting group title
    Active control group
    Reporting group description
    		 -

    Reporting group title
    Reference group (no treatment)
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental Group Active control group Reference group (no treatment)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 111 (1.80%)
    1 / 116 (0.86%)
    2 / 108 (1.85%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Adenoidectomy
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 116 (0.86%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 116 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 116 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 116 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental Group Active control group Reference group (no treatment)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 111 (62.16%)
    77 / 116 (66.38%)
    79 / 108 (73.15%)
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    40 / 111 (36.04%)
    61 / 116 (52.59%)
    72 / 108 (66.67%)
         occurrences all number
    69
    88
    131
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 111 (7.21%)
    5 / 116 (4.31%)
    7 / 108 (6.48%)
         occurrences all number
    8
    6
    8
    Rhinitis
         subjects affected / exposed
    7 / 111 (6.31%)
    2 / 116 (1.72%)
    3 / 108 (2.78%)
         occurrences all number
    8
    2
    4
    Bronchitis
         subjects affected / exposed
    6 / 111 (5.41%)
    9 / 116 (7.76%)
    7 / 108 (6.48%)
         occurrences all number
    7
    11
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 May 2013
    General and substantial amendment: Due to the seasonality of the disease, the recruitment period was stopped the 28.02.2013. The number of patients to be randomized was not achieved. The aim of this amendment was to postpone the study end period to February 2014 with a new recruitment phase in September and October 2013. Furthermore, a clarification should be done in the protocol concerning the reporting and counting of the number of flares for a given patient.

    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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