Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study

    Summary
    EudraCT number
    2008-003485-25
    Trial protocol
    LT   FR   EE   DE   PL   LV   IT  
    Global end of trial date
    23 May 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Dec 2016
    First version publication date
    01 Dec 2016
    Other versions
    Summary report(s)
    synopsis CSR V00034 CR 4 02 1B

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    V00034 CR 402 1B
    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
    Elisabeth COPPEL , Pierre Fabre Medicament IRPF 3 av Hubert Curien-31100 Toulouse, elisabeth.coppel@pierre-fabre.com
    Scientific contact
    Elisabeth COPPEL , Pierre Fabre Medicament IRPF 3 av 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
    22 Jan 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.
    Protection of trial subjects
    The trial was conducted according to Good Clinical Practices (CPMP/ICH/135/95), ICH E11, the Declaration of Helsinki and its subsequent amendments thereto and local legal regulations. Due to the absence of risk with the products and the study procedures, patients were allowed to participate to another clinical trial after study termination. The investigator registered side effects at each visit during clinical examination and questioning the parent(s)/guardian(s). At any time, if the patient's medical status required any other therapeutic (other that stated in protocol), the investigator could perform a final visit with a complete evaluation, then exclude the patient from the study and prescribe the appropriate treatment.
    Background therapy
    During disease exacerbation phases (presence of inflammatory lesions), a moderately potent corticosteroid cream (Locapred®, desonide 0.1%) was allowed, used as follows: - Locapred®: once a day (preferably in the evening) only on the lesions of the body and the face, Locapred® was used until complete resolution of the inflammatory signs. Conditions of use of Locapred® were explained to the parents. * When necessary, other treatments of atopic dermatitis signs/symptoms (antihistamines, antiseptics, zinc creams / ointments) were allowed and carefully notified. * Foaming gel Klorane® provided by the sponsor was allowed for children washing/cleansing.
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Oct 2008
    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
    Romania: 86
    Country: Number of subjects enrolled
    Poland: 113
    Country: Number of subjects enrolled
    Estonia: 118
    Country: Number of subjects enrolled
    France: 35
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Latvia: 117
    Country: Number of subjects enrolled
    Lithuania: 89
    Worldwide total number of subjects
    586
    EEA total number of subjects
    586
    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)
    2
    Children (2-11 years)
    584
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    591 patients were screened and 588 randomized and included. 2 patients did not take any treatment and therefore, the APT safety population was made of 586 patients.

    Pre-assignment
    Screening details
    Main inclusion criteria were - Age between 2 and 7 years, - atopic dermatitis according to the diagnostic criteria of the UK Working Party, - IGA score is ≤ 1 at inclusion,

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Experimental Group
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    V0034CR
    Investigational medicinal product code
    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. When inflammatory lesions were present (disease exacerbation phases), a moderately potent corticosteroid was allowed, used as followed: - Locapred®: once a day (preferably in the evening) only on the lesions of the body and the face, - V0034CR : once a day (preferably in the morning) on the whole body including 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 bid (morning and evening) on the whole body including face. When inflammatory lesions were present (disease exacerbation phases), a moderately potent corticosteroid was allowed, used as followed: - Locapred®: once a day (preferably in the evening) only on the lesions of the body and the face, - Vehicle: once a day (preferably in the morning) on the whole body including face.

    Number of subjects in period 1
    Experimental Group Vehicle Group
    Started
    294
    292
    Completed
    275
    272
    Not completed
    19
    20
         Adverse event, non-fatal
    11
    6
         Patient's or guardian's decision
    7
    5
         Other reason
    -
    2
         Worsening
    1
    6
         Lack of efficacy
    -
    1

    Baseline characteristics

    Close Top of page
    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
    294 292 586
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        geometric mean (full range (min-max))
    50.4 (14 to 95) 52.1 (16 to 94) -
    Gender categorical
    Units: Subjects
        Female
    145 151 296
        Male
    149 141 290
    IGA score
    5-point Investigator's Global Assessment (IGA) tool of skin desease from 0 clear to 5 very severe desease
    Units: Subjects
        clear
    111 119 230
        almost clear
    183 173 356
        missing
    0 0 0
    Subject analysis sets

    Subject analysis set title
    Safety data set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety had to be analysed in all randomized patients having used at least once the study medication

    Subject analysis set title
    Efficacy data set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All Patients Treated data set for efficacy , i.e. all randomized patients having used at least once the study medication and for which the main criterion is assessed at least once after inclusion.

    Subject analysis sets values
    Safety data set Efficacy data set
    Number of subjects
    586
    573
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        geometric mean (full range (min-max))
    51.2 (14 to 95)
    Gender categorical
    Units: Subjects
        Female
    296
        Male
    290
    IGA score
    5-point Investigator's Global Assessment (IGA) tool of skin desease from 0 clear to 5 very severe desease
    Units: Subjects
        clear
    230
        almost clear
    356
        missing
    0

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    -

    Reporting group title
    Vehicle Group
    Reporting group description
    -

    Subject analysis set title
    Safety data set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety had to be analysed in all randomized patients having used at least once the study medication

    Subject analysis set title
    Efficacy data set
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All Patients Treated data set for efficacy , i.e. all randomized patients having used at least once the study medication and for which the main criterion is assessed at least once after inclusion.

    Primary: Mean POEM (Patient -Oriented Eczema Mesure) score

    Close Top of page
    End point title
    Mean POEM (Patient -Oriented Eczema Mesure) score
    End point description
    The POEM score is a fully validated self or parental assessment of the frequency of the most bothering symptoms impacting the quality of life of the patient. The POEM score consists of 7 main symptoms: itchiness, dryness, skin-bleeding, skin weeping/oozing, sleep disturbance, skin flakes and cracks. Each symptom is scored on a five grade scale from 0 to 4, resulting a maximum score 28, where: - 0: no symptoms during the last week; - 1: one to two days of symptom's presence; - 2: three to four days of symptom's presence; - 3: five to six days of symptom's presence; - 4: everyday presence of the symptoms.
    End point type
    Primary
    End point timeframe
    Mean POEM score over the 12 weeks of treatment.
    End point values
    Experimental Group Vehicle Group
    Number of subjects analysed
    287
    286
    Units: Score
        arithmetic mean (confidence interval 95%)
    3.58 (3.14 to 4.01)
    3.91 (3.48 to 4.35)
    Statistical analysis title
    Mean POEM score over 12 weeks
    Statistical analysis description
    Analysis of variance for the POEM score using a Mixed Model for Repeated Measures (MMRM) with treatment, country and visit as fixed effects and subject as random effect.
    Comparison groups
    Experimental Group v Vehicle Group
    Number of subjects included in analysis
    573
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.2343 [2]
    Method
    Mixed models analysis
    Parameter type
    Variance
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -
         upper limit
    -
    Notes
    [1] - The initial POEM score was around 5.3/28 in both groups, which corresponds to atopic dermatitis of mild severity.
    [2] - The results of the primary analysis (MMRM) exhibited a difference in favour of the study drug (-0.34) but the difference was not statistically significant (p=0.2343).

    Adverse events

    Close Top of page
    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
    11.0
    Reporting groups
    Reporting group title
    Experimental Group
    Reporting group description
    -

    Reporting group title
    Vehicle Group
    Reporting group description
    -

    Serious adverse events
    Experimental Group Vehicle Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 294 (1.02%)
    9 / 292 (3.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile arthritis
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 292 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    0 / 294 (0.00%)
    2 / 292 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral skin infection
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 292 (0.34%)
         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
    Experimental Group Vehicle Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    159 / 294 (54.08%)
    150 / 292 (51.37%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    25 / 294 (8.50%)
    37 / 292 (12.67%)
         occurrences all number
    30
    42
    Rhinitis
         subjects affected / exposed
    25 / 294 (8.50%)
    16 / 292 (5.48%)
         occurrences all number
    30
    20
    Respiratory tract infection viral
         subjects affected / exposed
    17 / 294 (5.78%)
    15 / 292 (5.14%)
         occurrences all number
    18
    17
    Bronchitis
         subjects affected / exposed
    10 / 294 (3.40%)
    17 / 292 (5.82%)
         occurrences all number
    11
    18

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2008
    Substantial and general amendment. Following recommendations of Competent Authorities: - Addition of non inclusion criteria, - Addition of the warnings of associated treatment, - Modification in the "withdrawal criteria" section.
    14 Oct 2008
    Substantial and local amendment. Following recommendations of Ethics Committee in Milan and Competent Authorities in Italy, change of phase of the study.
    19 Dec 2008
    Substantial and local amendment. Following recommendations of Competent Authorities in Czech Republic, Change of phase of the study.
    10 Feb 2009
    Substantial and general amendment. - Addition of a contractor in charge of Investigational Product management, - Correction of the Associate Clinical Study Coordinator contact details, - Addition of investigators

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA