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    Clinical Trial Results:
    Efficacy and tolerance of the emollient cream V0034 CR in the symptomatic treatment of ichthyosis in children. International, multicentric, randomised, controlled, double blind study, in parallel groups V0034 CR versus vehicle.

    Summary
    EudraCT number
    		 2006-003369-14
    Trial protocol
    		 FI   EE   CZ   NL   DE   LT   FR   LV   IT   ES  
    Global end of trial date
    01 Nov 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Dec 2016
    First version publication date
    10 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V00034 CR 309 1B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Medicament
    Sponsor organisation address
    45, Place Abel Gance, Boulogne, France, 92100
    Public contact
    Elisabeth COPPEL, Centre de Recherche et Développement Clinique Pierre Fabre 3, Avenue Hubert CURIEN 31100 TOULOUSE, elisabeth.coppel@pierre-fabre.com
    Scientific contact
    Elisabeth COPPEL, Centre de Recherche et Développement Clinique Pierre Fabre 3, Avenue Hubert CURIEN 31100 TOULOUSE, elisabeth.coppel@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
    25 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy of a 4-week treatment by the emollient V0034CR in reducing the disease severity assessed by a specified symptom sum score (SRRC: Scales Roughness Redness Cracks fissures score) on both legs.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki and subsequent amendments thereto, the Good Clinical Practices (CPMP/ICH/135/95) and local legal régulations. Patient underwent a health assessment at the start of the study and remaines under regular Medical control during the whole study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2007
    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
    Czech Republic: 28
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Estonia: 50
    Country: Number of subjects enrolled
    Finland: 16
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Latvia: 38
    Country: Number of subjects enrolled
    Lithuania: 30
    Country: Number of subjects enrolled
    Poland: 40
    Country: Number of subjects enrolled
    Tunisia: 30
    Worldwide total number of subjects
    265
    EEA total number of subjects
    235
    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)
    36
    Children (2-11 years)
    146
    Adolescents (12-17 years)
    83
    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
    		 A total of 265 patients were included in the study and randomized in the two treatment groups. The study was performed in 12 countries and involved 21 centres. Among randomized patients, a total of 9 patients (3.4%) did not complete the study 3 (2.3%) in Vehicle group and 6 (4.5%) in V0034CR group. The main reason was lost to follow-up

    Pre-assignment
    Screening details
    		 Patients under 18 years suffering from a non-bullous form of ichthyosis with SRRC global score >=4 and scaling SRRC >=2 on both external faces of the legs. A double-blind period (V0034CR or vehicle) during 4 weeks followed by an open label period with all patients treated by V0034 CR for 8 weeks.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V0034
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    V0034
    Investigational medicinal product code
    V0034 CR
    Other name
    Dexeryl
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Twice a day on the whole body, in the morning and the evening for 4 weeks

    Arm title
    		 Vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Twice a day on the whole body in the morning and in the evening during 4 weeks

    Number of subjects in period 1 [1]
    		V0034 Vehicle
    Started
    131
    130
    Completed
    131
    130
    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: of the 265 enrolled and randomized patients worlwide, 9 patients ( 3.4%) did not complete the study; Mean reason for non completion was lost of follow up
    Period 2
    Period 2 title
    Open - label period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 V0034-8 weeks
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    V0034
    Investigational medicinal product code
    V0034 CR
    Other name
    Dexeryl
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Twice a day on the whole body, in the morning and the evening for 4 weeks

    Number of subjects in period 2 [2]
    		V0034-8 weeks
    Started
    258
    Completed
    258
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: only subjects treated by V0034 CR were enrolled in the open label 4week follow up period

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V0034
    Reporting group description
    		 -

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Reporting group values
    		 V0034 Vehicle Total
    Number of subjects
    		 131 130 261
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 9.18 (0.1 to 17.9) 8.52 (0.2 to 17.9) -
    Gender categorical
    Units: Subjects
        Female
    		 43 48 91
        Male
    		 88 82 170
    type of ichtyosis
    Units: Subjects
        Ichthyosis vulgaris
    		 78 81 159
        X linked recessive ichthyosis
    		 15 21 36
        Non erythrodermic ichthyosis
    		 22 15 37
        Other
    		 16 13 29
    Scaling score
    Visual evaluation of scaling syptom on a five-point scale: 0 Absent 1 Slight: small scales only, surface lightly dull in colour 2 Moderate: small scales in combination with larger scales (>0.05mm), surface opaque or whitish 3 Severe: larger and large scales (flakes >1mm) are prominent, surface whitish Scaling (visual evaluation) 4 Extreme: larger flakes covering almost the entire skin surface in the examination field
    Units: Subjects
        absent
    		 0 0 0
        slight
    		 0 0 0
        moderate
    		 48 43 91
        severe
    		 62 72 134
        extreme
    		 21 15 36
    SRRC score
    Four symptoms, scaling, roughness, redness and cracks on both legs were rated on a five-grade scale from 0 absent to 4 extreme The SRRC score was the sum of these four symptom grades. The maximum score was 16.
    Units: decimal
        arithmetic mean (full range (min-max))
    		 7.47 (4 to 14) 7.12 (3 to 13) -
    Subject analysis sets

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised patients having taken at least one dose of study treatment.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients having taken at least one dose of study treatment and with at least one post baseline evaluation of the primary efficacy criterion.

    Subject analysis set title
    Full Analysis Set excluding one country
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients having taken at least one dose of study treatment and with at least one post baseline evaluation of the primary efficacy criterion, excluding patients from Tunisia (because unexpected results in this country- 100% responders in both groups).

    Subject analysis sets values
    		 Safety data set Full analysis set Full Analysis Set excluding one country
    Number of subjects
    262
    261
    231
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    8.84 (0.1 to 17.9)
    8.85 (0.1 to 17.9)
    8.68 (0.1 to 17.9)
    Gender categorical
    Units: Subjects
        Female
    91
    91
    79
        Male
    171
    170
    152
    type of ichtyosis
    Units: Subjects
        Ichthyosis vulgaris
    159
        X linked recessive ichthyosis
    36
        Non erythrodermic ichthyosis
    37
        Other
    29
    Scaling score
    Visual evaluation of scaling syptom on a five-point scale: 0 Absent 1 Slight: small scales only, surface lightly dull in colour 2 Moderate: small scales in combination with larger scales (>0.05mm), surface opaque or whitish 3 Severe: larger and large scales (flakes >1mm) are prominent, surface whitish Scaling (visual evaluation) 4 Extreme: larger flakes covering almost the entire skin surface in the examination field
    Units: Subjects
        absent
    0
        slight
    0
        moderate
    91
        severe
    134
        extreme
    36
    SRRC score
    Four symptoms, scaling, roughness, redness and cracks on both legs were rated on a five-grade scale from 0 absent to 4 extreme The SRRC score was the sum of these four symptom grades. The maximum score was 16.
    Units: decimal
        arithmetic mean (full range (min-max))
    7.3 (3 to 14)

    End points

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    End points reporting groups
    Reporting group title
    V0034
    Reporting group description
    		 -

    Reporting group title
    Vehicle
    Reporting group description
    		 -
    Reporting group title
    V0034-8 weeks
    Reporting group description
    		 -

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All randomised patients having taken at least one dose of study treatment.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients having taken at least one dose of study treatment and with at least one post baseline evaluation of the primary efficacy criterion.

    Subject analysis set title
    Full Analysis Set excluding one country
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomised patients having taken at least one dose of study treatment and with at least one post baseline evaluation of the primary efficacy criterion, excluding patients from Tunisia (because unexpected results in this country- 100% responders in both groups).

    Primary: Patients having a 50% reduction of the SRRC score (Scaling, Roughness, Redness, Cracks fissures score) on FAS including all countries

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    End point title
    		 Patients having a 50% reduction of the SRRC score (Scaling, Roughness, Redness, Cracks fissures score) on FAS including all countries
    End point description
    The primary efficacy criterion was the response to treatment defined by a decrease of at least 50% of the SRRC score on the external face of legs (mean of the 2 legs) between baseline and Day 28. The main analysis of the primary efficacy criterion was performed on the FAS population (All countries) using the Cochran Mantel Haenszel test stratified by centre.
    End point type
    Primary
    End point timeframe
    From baseline to Day 28
    End point values
    		 V0034 Vehicle Full analysis set
    Number of subjects analysed
    131
    130
    261
    Units: Patient
    85
    65
    150
    Statistical analysis title
    		 Primary efficacy analysis
    Statistical analysis description
    Responses to treatment defined by a decrease of at least 50% of the SRRC score (mean of the 2 legs) between the 2 arms were compared using the Cochran-Mantel-Haenszel (CMH) test stratified by type of ichtyosis
    Comparison groups
    Vehicle v V0034
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.008 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - The CMH test was performed on the FAS including all countries to assess whether the response (i.e. decrease in the SRRC score by at least 50% on Day 28) was independent of treatment (explanatory variable) when adjusting for group of countries.
    [2] - The difference between the two treatment groups was statistically significant (p=0.008) adjusted for pooled centres.

    Primary: Patients having a 50% reduction of the SRRC score (Scaling, Roughness, Redness, Cracks fissures score) on FAS excluding one country

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    End point title
    		 Patients having a 50% reduction of the SRRC score (Scaling, Roughness, Redness, Cracks fissures score) on FAS excluding one country [3]
    End point description
    The main analysis of the primary efficacy criterion was performed also on the FAS excluding Tunisia, using the Cochran Mantel Haenszel test stratified by centre. (Thirty patients from two centres were excluded from FAS analysis because of doubtful drug administration and results, with a 100% of responders in both groups.)
    End point type
    Primary
    End point timeframe
    From Baseline to Day 28
    Notes
    [3] - 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: No analysis has been performed
    End point values
    Number of subjects analysed
    Units: subjects
    No statistical analyses for this end point

    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
    8.1
    Reporting groups
    Reporting group title
    Vehicle group
    Reporting group description
    		 -

    Reporting group title
    Experimental Group
    Reporting group description
    		 -

    Serious adverse events
    		 Vehicle group Experimental Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 130 (2.31%)
    2 / 132 (1.52%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Ichthyosis
    Additional description: Exacerbation of known ichtyosis (post-study ).
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Talipes correction
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vehicle group Experimental Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 130 (20.00%)
    30 / 132 (22.73%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 130 (6.92%)
    9 / 132 (6.82%)
         occurrences all number
    9
    12
    Rhinitis
         subjects affected / exposed
    12 / 130 (9.23%)
    6 / 132 (4.55%)
         occurrences all number
    13
    6
    Pharyngitis
         subjects affected / exposed
    7 / 130 (5.38%)
    2 / 132 (1.52%)
         occurrences all number
    8
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2006
    Substantial-general - all countries: Life style change in the information consent form following a discrepansy between protocol and Information consent.
    11 Dec 2006
    Substantial-local amendment (Czech Republic): Precision of one non inclusion criteria and modification of Inform consent Form . The protocol was modified with the addition of "pregnancy test" where appropriate.
    14 Mar 2007
    Substantial-general - all countries: Modification of the dates of study schedule

    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/22118417
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