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    Clinical Trial Results:
    RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND EFFICACY STUDY OF THE EMOLLIENT V0034CR IN ADDITION TO A MODERATELY POTENT CORTICOSTEROID IN THE ACUTE PHASE OF TREATMENT OF ATOPIC DERMATITIS IN INFANTS.

    Summary
    EudraCT number
    2005-002803-18
    Trial protocol
    FR   FI   EE   LV   DE  
    Global end of trial date
    22 Jun 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
    • Correction of full data set
    Add full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    V00034CR3041B
    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, +33 5.61.73.73.09, alain.delarue@pierre-fabre.com
    Scientific contact
    Alain DELARUE, M.D, Institut de recherche 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
    25 Sep 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the short term efficacy of the emollient V0034CR in addition to a moderately potent topical corticosteroid in the acute phase of treatment of atopic dermatitis, by reducing the disease severity.
    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. An information letter was given to the parent(s) or guardian(s) of each patient to assist them with their decision. Parent(s) or guardian(s) signed a written consent form, which described the details and constraints of the study, as well as the right to withdraw at any point, anonymity, and the right to access the data. The parent(s) or guardian(s), the investigator each had a copy of the signed consent form, as well as the sponsor for which it was sealed in an envelope to maintain confidentiality.
    Background therapy
    Corticosteroid treatment was used by the parents on the lesions 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 (one 250 mL bottle for 3 weeks; batch F727; expiry date: 10/2007). Way of life and cosmetic cares should not be changed. Food supplements that could modify the skin properties as well as swimming pool were not allowed.
    Evidence for comparator
    Due to the natural evolution of the disease, the parallel groups design was the only one adapted to the study purpose. Very few emollients have been evaluated double blind, thus contributing to the lack of proofs of their efficacy. In order to evaluate the benefit of the emollient V0034CR, placebo was mandatory and justified. Furthermore, the use of a placebo was ethically acceptable since all patients received an active treatment by corticosteroids for treating inflammatory signs.
    Actual start date of recruitment
    19 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
    Poland: 81
    Country: Number of subjects enrolled
    Romania: 17
    Country: Number of subjects enrolled
    Estonia: 88
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Latvia: 80
    Worldwide total number of subjects
    320
    EEA total number of subjects
    320
    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)
    320
    Children (2-11 years)
    0
    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
    A total of 322 patients were included in the study and randomized in the two treatment groups (19 centres in 7 countries). Two patients (Vehicle group) prematurely withdrew without any treatment application and any evaluation after inclusion.

    Pre-assignment
    Screening details
    Patients, male or female infants, aged between 3 and 24 months, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party; with SCORAD 20 to 50; whose xerosis was > 1; requiring topical corticosteroid treatment, moderately potent, on the body and/or the face were screened.

    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 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
    Vehicle arm
    Arm description
    -
    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
    When inflammatory lesions were present (disease exacerbation phases): application on the whole body, in the evening. When inflammatory lesions had disappeared: application on the whole body, morning and evening, with a gentle massage until complete penetration. Applications of the study product were done in thin layers with a sufficient amount of cream.

    Arm title
    V0034CR arm
    Arm description
    -
    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
    When inflammatory lesions were present (disease exacerbation phases): application on the whole body, in the evening, with a gentle massage until complete penetration. When inflammatory lesions had disappeared: application on the whole body, morning and evening. Applications of the study product were done in thin layers with a sufficient amount of cream by a gentle massage until complete penetration.

    Number of subjects in period 1
    Vehicle arm V0034CR arm
    Started
    157
    163
    Completed
    153
    160
    Not completed
    4
    3
         Adverse events
    1
    1
         Lost to follow-up
    1
    -
         Worsening
    1
    1
         Parent's decision
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vehicle arm
    Reporting group description
    -

    Reporting group title
    V0034CR arm
    Reporting group description
    -

    Reporting group values
    Vehicle arm V0034CR arm Total
    Number of subjects
    157 163 320
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    157 163 320
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    11.3 ± 5.8 12.3 ± 6.0 -
    Gender categorical
    Units: Subjects
        Female
    60 72 132
        Male
    97 91 188
    Family history of atopy
    Units: Subjects
        Yes
    116 123 239
        No
    41 40 81
    IGA score at baseline
    Units: Subjects
        Mild disease
    63 65 128
        Moderate disease
    92 93 185
        Severe disease
    2 5 7
    Height
    Units: cm
        arithmetic mean (standard deviation)
    75.3 ± 8.8 75.3 ± 8.7 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    9.69 ± 2.37 9.85 ± 2.33 -
    Age of first cutaneous lesions
    Units: months
        arithmetic mean (standard deviation)
    3.5 ± 2.7 4.0 ± 3.5 -
    SCORAD at baseline
    Units: not applicable
        arithmetic mean (standard deviation)
    34.0 ± 6.9 33.5 ± 7.4 -

    End points

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    End points reporting groups
    Reporting group title
    Vehicle arm
    Reporting group description
    -

    Reporting group title
    V0034CR arm
    Reporting group description
    -

    Primary: Evolution of SCORAD between baseline and D22 (or endpoint)

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    End point title
    Evolution of SCORAD between baseline and D22 (or endpoint)
    End point description
    The change in SCORAD between D1 and D22 was compared between treatment groups by a covariance analysis using the baseline SCORAD as a covariate with the treatment and the centre effects. Drop-outs patients were included in the analyses on the APTe population except for two patients with no available assessment of the main efficacy criterion. If the evaluation at Visit 4 (D22) was missing, it was replaced by the last evaluation on treatment (Last Observation Carried Forward).
    End point type
    Primary
    End point timeframe
    The SCORAD score was measured at baseline (Day 1) and at Day 22.
    End point values
    Vehicle arm V0034CR arm
    Number of subjects analysed
    157
    163
    Units: not applicable
        arithmetic mean (standard deviation)
    -22.06 ± 0.7
    -23.07 ± 0.7
    Statistical analysis title
    Primary analysis
    Statistical analysis description
    Covariance analysis using baseline as a covariate with the treatment and the centre effects.
    Comparison groups
    V0034CR arm v Vehicle arm
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.2145
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    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 (D8 +/- 1) to Visit 4 (D22 +/- 1).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    Vehicle arm
    Reporting group description
    -

    Reporting group title
    V0034 CR arm
    Reporting group description
    -

    Serious adverse events
    Vehicle arm V0034 CR arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (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: 0.6%
    Non-serious adverse events
    Vehicle arm V0034 CR arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 157 (17.20%)
    31 / 163 (19.02%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 157 (2.55%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    Hyperthermia
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Unevaluable event
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    conjuctivitis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 157 (2.55%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    Abdominal pain
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Enterocolitis
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 157 (2.55%)
    3 / 163 (1.84%)
         occurrences all number
    4
    3
    Rhinitis allergic
         subjects affected / exposed
    1 / 157 (0.64%)
    1 / 163 (0.61%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Intertrigo
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 157 (4.46%)
    6 / 163 (3.68%)
         occurrences all number
    7
    6
    Viral infection
         subjects affected / exposed
    4 / 157 (2.55%)
    3 / 163 (1.84%)
         occurrences all number
    4
    3
    Rhinitis
         subjects affected / exposed
    0 / 157 (0.00%)
    5 / 163 (3.07%)
         occurrences all number
    0
    5
    Bronchitis
         subjects affected / exposed
    1 / 157 (0.64%)
    1 / 163 (0.61%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 157 (0.00%)
    2 / 163 (1.23%)
         occurrences all number
    0
    2
    Varicella
         subjects affected / exposed
    0 / 157 (0.00%)
    2 / 163 (1.23%)
         occurrences all number
    0
    2
    Acute tonsillitis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Bronchiolitis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    bronchitis acute
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    1 / 157 (0.64%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    Viral diarrhoea
         subjects affected / exposed
    0 / 157 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1

    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 (Germany)
    27 Feb 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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