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    Clinical Trial Results:
    LONG-TERM MANAGEMENT OF ATOPIC DERMATITIS WITH THE EMOLLIENT V0034 CR. A RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUPS, DOUBLE-BLIND STUDY IN INFANTS AND CHILDREN

    Summary
    EudraCT number
    2005-003396-21
    Trial protocol
    FR   EE   FI   LV   DE  
    Global end of trial date
    07 Nov 2006

    Results information
    Results version number
    v2(current)
    This version publication date
    11 May 2019
    First version publication date
    21 Nov 2018
    Other versions
    v1
    Version creation reason
    • Changes to summary attachments
    Synopsis error

    Trial information

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    Trial identification
    Sponsor protocol code
    V00034CR3071B
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Médicament
    Sponsor organisation address
    45, Place Abel Gance, Boulogne, France, 92100
    Public contact
    Alain DELARUE, M.D, INSTITUT DE RECHERCHE PIERRE FABRE Innovation Développement Pierre Fabre , +33 5.61.73.73.09, alain.delarue@pierre-fabre.com
    Scientific contact
    Alain DELARUE, M.D, INSTITUT DE RECHERCHE PIERRE FABRE Innovation Développement Pierre Fabre , +33 5.61.73.73.09, alain.delarue@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?
    Yes
    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
    07 Sep 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the overall benefit of a regular treatment by the emollient V0034CR in the management of atopic dermatitis: reduction of corticosteroids consumption, reduction of flares
    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 regulations.
    Background therapy
    Corticosteroid treatment was used by the parents on the lesions where they appeared, until complete resolution of the inflammatory signs, mainly the resolution of erythema. For their child's body and scalp washing, parents used the foaming gel Klorane* provided by the sponsor: bottle 250 mL; batch F727; expiry date: 10/2007 or bottle 500 mL; batch F742; expiry date: 12/2007. Way of life and cosmetic cares should not be changed. Food supplements that could modify the skin properties. Just after being in a swimming pool, emollient should be applied once more.
    Evidence for comparator
    Very few emollients have been evaluated double blind. In order to evaluate the effect of the emollient V0034 CR 01B, placebo was mandatory and justified. Furthermore, the use of a placebo (vehicle) was ethically acceptable since all patients received when necessary an active treatment by corticosteroids on one hand and because excipient topical formulations have also a well-known intrinsic activity that can improve the skin status.
    Actual start date of recruitment
    30 Nov 2005
    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
    Estonia: 83
    Country: Number of subjects enrolled
    Finland: 20
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Latvia: 81
    Country: Number of subjects enrolled
    Poland: 84
    Country: Number of subjects enrolled
    Romania: 29
    Worldwide total number of subjects
    328
    EEA total number of subjects
    328
    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)
    98
    Children (2-11 years)
    230
    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
    Twenty two centres in 7 countries screened and treated 328 patients, male or female children, aged between 3 months and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party between the 30th of November 2005 and 07 September 2006.

    Pre-assignment
    Screening details
    Patients, male or female children, aged between 3 months and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party, whose IGA score was < 1 at inclusion were screened. Patients in acute phase of AD or with a severe form of disease were excluded.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The study products as well as their packaging and labelling were rigorously identical. The investigator, the hospital pharmacist if appropriate, the study monitor had a set of blind sealed envelops corresponding to the treatments received and given to the patients. An envelope could be opened only in case of emergency (vital threatening, emergency) and only if the knowledge of the product having been received was necessary to start appropriate treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    V0034CR arm
    Arm description
    160 patients were randomised in the V0034CR arm
    Arm type
    Experimental

    Investigational medicinal product name
    V0034 CR 01B cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Application in thin layers with a sufficient amount of cream, with a gentle massage until penetration, on the whole body (including face), morning and evening; when inflammatory lesions were present (disease exacerbation phases): application on the whole body (including face), in the evening. The study was long enough (6 months) to have flares during one winter/spring season and thus to register corticosteroid consumption. Corticosteroid treatment was applied by the parents only on the inflammatory lesions until complete resolution of the inflammatory signs (if applicable).

    Arm title
    Vehicle arm
    Arm description
    168 patients were randomised in the vehicle arm
    Arm type
    Placebo

    Investigational medicinal product name
    Vehicle cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Application in thin layers with a sufficient amount of cream, with a gentle massage until penetration, on the whole body (including face), morning and evening; when inflammatory lesions were present (disease exacerbation phases): application on the whole body (including face), in the evening. The corticosteroid treatment was applied by the parents only on the inflammatory lesions until complete resolution of the inflammatory signs.

    Number of subjects in period 1
    V0034CR arm Vehicle arm
    Started
    160
    168
    Completed
    151
    153
    Not completed
    9
    15
         Patient's or guardian's decision
    2
    8
         Worsening
    3
    5
         Insufficient response
    2
    2
         Non serious AEs/SAEs
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V0034CR arm
    Reporting group description
    160 patients were randomised in the V0034CR arm

    Reporting group title
    Vehicle arm
    Reporting group description
    168 patients were randomised in the vehicle arm

    Reporting group values
    V0034CR arm Vehicle arm Total
    Number of subjects
    160 168 328
    Age categorical
    Units: Subjects
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    50 48 98
        Children (2-11 years)
    110 120 230
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    37.6 ± 22.0 36.6 ± 21.3 -
    Gender categorical
    Units: Subjects
        Female
    75 89 164
        Male
    85 79 164
    Family history of atopy
    Units: Subjects
        Yes
    120 130 250
        No
    40 38 78
    IGA score
    Units: Subjects
        Clear
    49 72 121
        Almost clear
    111 96 207
    Height
    Units: cm
        arithmetic mean (standard deviation)
    95.8 ± 16.6 95.3 ± 15.3 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    15.2 ± 5.24 14.49 ± 4.24 -
    Age of first cutaneous lesion
    Units: months
        arithmetic mean (standard deviation)
    7.5 ± 0.096 7.9 ± 0.08 -
    Time between last flare and inclusion
    Units: days
        arithmetic mean (standard deviation)
    106.8 ± 150.9 102.2 ± 139.6 -
    SCORAD at baseline
    Units: not applicable
        arithmetic mean (full range (min-max))
    16.4 (0 to 35) 15.9 (0 to 45) -

    End points

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    End points reporting groups
    Reporting group title
    V0034CR arm
    Reporting group description
    160 patients were randomised in the V0034CR arm

    Reporting group title
    Vehicle arm
    Reporting group description
    168 patients were randomised in the vehicle arm

    Primary: Number of days of application of corticosteroid.

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    End point title
    Number of days of application of corticosteroid.
    End point description
    The main criterion was the number of days of application of corticosteroid (percentage of the total number of days in the study). To take into account not only dropouts but also different durations in the study for completers, this number of days was expressed as a percentage of the total number of days in the study. This percentage was compared between treatment groups using Cochran-Mantel-Haenszel (CMH) with modified ridit scores, adjusting for centre.
    End point type
    Primary
    End point timeframe
    The number of days of application of corticosteroid was measured between the first visit of the study until the final visit (week 24)
    End point values
    V0034CR arm Vehicle arm
    Number of subjects analysed
    160
    168
    Units: percentage
        arithmetic mean (standard deviation)
    5.4 ± 7.98
    7.74 ± 11.28
    Statistical analysis title
    Primary analysis
    Statistical analysis description
    The main criteria (number of days of application of a moderately potent corticosteroids used for treating flares) was compared between treatment groups using Cochran-Mantel-Haenszel test (row mean scores) adjusting for centre, using modified ridit scores to get an extension of the Wilcoxon rank sum test.
    Comparison groups
    V0034CR arm v Vehicle arm
    Number of subjects included in analysis
    328
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.429
    Method
    Mantel-Haenszel
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -
         upper limit
    -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the visit 2 (W4) until the final visit Visit 6 (W24).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    V0034 CR arm
    Reporting group description
    -

    Reporting group title
    Vehicle arm
    Reporting group description
    -

    Serious adverse events
    V0034 CR arm Vehicle arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 160 (0.00%)
    3 / 168 (1.79%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Otoplasty
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 168 (0.60%)
         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 / 160 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 160 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    V0034 CR arm Vehicle arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 160 (55.00%)
    100 / 168 (59.52%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    12 / 160 (7.50%)
    14 / 168 (8.33%)
         occurrences all number
    12
    14
    General disorders and administration site conditions
    general disorders and administration site conditions
         subjects affected / exposed
    7 / 160 (4.38%)
    11 / 168 (6.55%)
         occurrences all number
    7
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 160 (5.63%)
    10 / 168 (5.95%)
         occurrences all number
    9
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    21 / 160 (13.13%)
    14 / 168 (8.33%)
         occurrences all number
    21
    14
    Rhinitis
         subjects affected / exposed
    11 / 160 (6.88%)
    14 / 168 (8.33%)
         occurrences all number
    11
    14
    Pharyngitis
         subjects affected / exposed
    13 / 160 (8.13%)
    9 / 168 (5.36%)
         occurrences all number
    13
    9
    Bronchitis
         subjects affected / exposed
    9 / 160 (5.63%)
    10 / 168 (5.95%)
         occurrences all number
    9
    10
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 160 (5.63%)
    10 / 168 (5.95%)
         occurrences all number
    9
    10
    Ear infection
         subjects affected / exposed
    6 / 160 (3.75%)
    9 / 168 (5.36%)
         occurrences all number
    6
    9

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2005
    Modification of the Subject information leaflet and consent form (French version), following the CCPPRB remarks (during the session of august 17, 2005)
    29 Nov 2005
    Modification of the dates of study schedule
    29 Nov 2005
    Precisions for some non inclusion criteria, conditions of use of Locapred and withdrawal conditions
    20 Jan 2006
    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
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