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    Clinical Trial Results:
    Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extension

    Summary
    EudraCT number
    		 2011-003295-37
    Trial protocol
    		 FR   EE   LT   PL  
    Global end of trial date
    24 May 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V00034CR3121B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01467362
    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
    20 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of V0034CR01B cream on xerosis in children with atopic dermatitis in comparison with vehicle over 28 days.
    Protection of trial subjects
    Medical and clinical examination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 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
    Poland: 59
    Country: Number of subjects enrolled
    Estonia: 79
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Lithuania: 67
    Country: Number of subjects enrolled
    Romania: 26
    Worldwide total number of subjects
    249
    EEA total number of subjects
    249
    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)
    249
    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
    		 251 patients were randomised but only 249 patients were randomised and treated. 2 patients did not take any treatment (1 withdrawn patient for parents decision in each arm); safety and efficacy population was composed of 249 patients.

    Pre-assignment
    Screening details
    		 Patients who met all inclusion criteria and none of exclusion criteria were randomised into 2 groups, V0034CR01B or vehicle, and during 28 days received treatment. After this first period, according to the status of lesions and xerosis score, patients entered an open-label period for 56 days (V0034CR01B or started a treatment free follow-up).

    Period 1
    Period 1 title
    Double-blind period Day 1 to Day 28
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    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 twice a day (morning and evening) on the whole body including face. When inflammatory lesions were present (disease exacerbation phases), the product was applied once a day (in the morning) on the whole body including the face, and a moderately potent corticosteroid (Locapred®) was applied once a day (in the evening) only on the lesions of the body and the face.

    Arm title
    		 Vehicle Group
    Arm description
    		 -
    Arm type
    		 Vehicle

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    One application twice a day (morning and evening) on the whole body including face. When inflammatory lesions were present (disease exacerbation phases), the product was applied once a day (in the morning) on the whole body including the face, and a moderately potent corticosteroid (Locapred®) was applied once a day (in the evening) only on the lesions of the body and the face.

    Number of subjects in period 1
    		Experimental Group Vehicle Group
    Started
    124
    125
    Completed
    120
    121
    Not completed
    4
    4
         Parents decision
    2
    -
         Adverse event, non-fatal
    1
    3
         Lack of efficacy
    1
    1
    Period 2
    Period 2 title
    Open-label Period Day 28 to Day 56
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental Group
    Arm description
    		 On Day 28, if patients had persisting lesions and/or xerosis score >1 at Day 28, the application of experimental treatment started (Patients from double-blind vehicle group) or continued (patients from double blind experimental group).
    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 twice a day (morning and evening) on the whole body including face. When inflammatory lesions were present (disease exacerbation phases), the product was applied once a day (in the morning) on the whole body including the face, and a moderately potent corticosteroid (Locapred®) was applied once a day (in the evening) only on the lesions of the body and the face.

    Arm title
    		 Treatment free follow-up Group
    Arm description
    		 On Day 28, only patients without persisting lesions and xerosis score ≤ 1 started treatment free follow-up.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Experimental Group Treatment free follow-up Group
    Started
    155
    86
    Completed
    154
    86
    Not completed
    1
    0
         Parents decision
    1
    -
    Period 3
    Period 3 title
    Open-label Period Day 56 to Day 84
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental group
    Arm description
    		 On day 56: if patients had persisting lesions and/or xerosis score >1 at D56, the application of experimental product started or continued. Patients treated with Experimental product between Day 28 and Day 56 could not started treatment free follow-up, even if their skin at Day 56 was free from lesions and xerosis score ≤1.
    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 twice a day (morning and evening) on the whole body including face. When inflammatory lesions were present (disease exacerbation phases), the product was applied once a day (in the morning) on the whole body including the face, and a moderately potent corticosteroid (Locapred®) was applied once a day (in the evening) only on the lesions of the body and the face.

    Arm title
    		 Treatment free follow-up Group
    Arm description
    		 Only patients without persisting lesions and xerosis score ≤1 at Day 56 continued treatment free started at Day 28.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Experimental group Treatment free follow-up Group
    Started
    227
    13
    Completed
    225
    13
    Not completed
    2
    0
         Parents decision
    1
    -
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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

    Reporting group title
    Vehicle Group
    Reporting group description
    		 -

    Reporting group values
    		 Experimental Group Vehicle Group Total
    Number of subjects
    		 124 125 249
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 4.04 (2 to 6.9) 4.05 (2 to 6.9) -
    Gender categorical
    Units: Subjects
        Female
    		 69 53 122
        Male
    		 55 72 127
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients having received at least one application of the study treatment, used to perform the analysis of safety and efficacy.

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    249
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    4.05 (2 to 6.9)
    Gender categorical
    Units: Subjects
        Female
    122
        Male
    127

    End points

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

    Reporting group title
    Vehicle Group
    Reporting group description
    		 -
    Reporting group title
    Experimental Group
    Reporting group description
    		 On Day 28, if patients had persisting lesions and/or xerosis score >1 at Day 28, the application of experimental treatment started (Patients from double-blind vehicle group) or continued (patients from double blind experimental group).

    Reporting group title
    Treatment free follow-up Group
    Reporting group description
    		 On Day 28, only patients without persisting lesions and xerosis score ≤ 1 started treatment free follow-up.
    Reporting group title
    Experimental group
    Reporting group description
    		 On day 56: if patients had persisting lesions and/or xerosis score >1 at D56, the application of experimental product started or continued. Patients treated with Experimental product between Day 28 and Day 56 could not started treatment free follow-up, even if their skin at Day 56 was free from lesions and xerosis score ≤1.

    Reporting group title
    Treatment free follow-up Group
    Reporting group description
    		 Only patients without persisting lesions and xerosis score ≤1 at Day 56 continued treatment free started at Day 28.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients having received at least one application of the study treatment, used to perform the analysis of safety and efficacy.

    Primary: Xerosis score : mean evolution over the different time-points of double-blind period

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    End point title
    		 Xerosis score : mean evolution over the different time-points of double-blind period
    End point description
    The primary criterion was the change from baseline of the xerosis score over the different time-points of the double-blind period for patients included in the Full Analysis Set.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Day 7, Day 14, Day 21 and Day 28
    End point values
    		 Experimental Group Vehicle Group
    Number of subjects analysed
    124
    125
    Units: not applicable
        least squares mean (standard error)
    -0.93 ( 0.043 )
    -0.63 ( 0.043 )
    Statistical analysis title
    		 Adjusted mean difference in change (xerosis score)
    Statistical analysis description
    Analysis of the change from baseline to day 28 using a Mixed-effects Model for Repeated Measures (MMRM) (observed values from the mean changes in xerosis score at all time points up to day 28).
    Comparison groups
    Experimental Group v Vehicle Group
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 -0.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.061

    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
    14.0
    Reporting groups
    Reporting group title
    Double-blind period : Experimental Group
    Reporting group description
    		 -

    Reporting group title
    Double blind : Vehicle group
    Reporting group description
    		 -

    Reporting group title
    Open-Label Day 28 to Day 56 : Experimental group
    Reporting group description
    		 -

    Reporting group title
    Open-Label Day 28 to Day 56 : Follow-up group
    Reporting group description
    		 -

    Reporting group title
    Open-Label Day 56 to Day 84 : Experimental group
    Reporting group description
    		 -

    Reporting group title
    Open-Label Day 56 to Day 84 : Follow-up group
    Reporting group description
    		 -

    Serious adverse events
    		 Double-blind period : Experimental Group Double blind : Vehicle group Open-Label Day 28 to Day 56 : Experimental group Open-Label Day 28 to Day 56 : Follow-up group Open-Label Day 56 to Day 84 : Experimental group Open-Label Day 56 to Day 84 : Follow-up group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 155 (0.00%)
    0 / 86 (0.00%)
    0 / 227 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 155 (0.00%)
    0 / 86 (0.00%)
    0 / 227 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-blind period : Experimental Group Double blind : Vehicle group Open-Label Day 28 to Day 56 : Experimental group Open-Label Day 28 to Day 56 : Follow-up group Open-Label Day 56 to Day 84 : Experimental group Open-Label Day 56 to Day 84 : Follow-up group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 124 (27.42%)
    42 / 125 (33.60%)
    27 / 155 (17.42%)
    8 / 86 (9.30%)
    39 / 227 (17.18%)
    2 / 13 (15.38%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 125 (0.80%)
    1 / 155 (0.65%)
    1 / 86 (1.16%)
    7 / 227 (3.08%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    1
    1
    7
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 124 (1.61%)
    3 / 125 (2.40%)
    1 / 155 (0.65%)
    0 / 86 (0.00%)
    3 / 227 (1.32%)
    1 / 13 (7.69%)
         occurrences all number
    4
    4
    1
    0
    3
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 124 (5.65%)
    7 / 125 (5.60%)
    5 / 155 (3.23%)
    1 / 86 (1.16%)
    6 / 227 (2.64%)
    0 / 13 (0.00%)
         occurrences all number
    7
    7
    5
    1
    6
    0
    Rhinitis
         subjects affected / exposed
    1 / 124 (0.81%)
    5 / 125 (4.00%)
    2 / 155 (1.29%)
    1 / 86 (1.16%)
    2 / 227 (0.88%)
    1 / 13 (7.69%)
         occurrences all number
    1
    5
    2
    1
    2
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24267728
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