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    Clinical Trial Results:
    Ensayo clínico aleatorizado, doble ciego con propionato de fluticasona tópico 2 veces por semana, como tratamiento de mantenimiento, para reducir el riesgo de recidivas de dermatitis atópica leve o moderada en niño. Randomised controlled, double blind trial of topical twice weekly fluticasone propionate maintenance treatment to reduce risk of relapse in mild or moderate atopic dermatitis in children.

    Summary
    EudraCT number
    2008-005360-14
    Trial protocol
    ES  
    Global end of trial date
    27 Apr 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Oct 2022
    First version publication date
    21 Oct 2022
    Other versions
    Summary report(s)
    Medical jurnal article Rubio-Gomis et al

    Trial information

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    Trial identification
    Sponsor protocol code
    FLUTIDANENES08
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01772056
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    ISCIII. Ministerio de Ciencia e Innovación: EC08/00004
    Sponsors
    Sponsor organisation name
    Instituto de Salud Carlos III
    Sponsor organisation address
    C/ Sinesio Delgado, 4, Madrid, Spain, 28029
    Public contact
    Instituto de Salud Carlos III, Instituto de Salud Carlos III (ISCIII), +34 91 822 24 51, comunicacion@isciii.es
    Scientific contact
    Instituto de Salud Carlos III, Instituto de Salud Carlos III, +34 91 822 24 51, comunicacion@isciii.es
    Sponsor organisation name
    Consorcio Hospital General Universitario de Valencia
    Sponsor organisation address
    Avda Tres Cruces nº2, Valencia, Spain, 46014
    Public contact
    Elena Rubio. Unidad de Farmacología Clínica Consorcio Hospital General Universitario de Valencia, Elena Rubio. Consorcio Hospital General Universitario de Valencia, +34 964972140, elena.rubio@uv.es
    Scientific contact
    Elena Rubio. Unidad de Farmacología Clínica Consorcio Hospital General Universitario de Valencia, Elena Rubio. Consorcio Hospital General Universitario de Valencia, +34 961972140, elena.rubio@uv.es
    Sponsor organisation name
    Fundacion Investigación Hospital General Universitario de Valencia
    Sponsor organisation address
    Avda Tres Cruces nº2, Valencia, Spain, 46014
    Public contact
    Fundacion Investigación Hospital General Universitario de Valencia, Fundacion Investigación Hospital General Universitario de Valencia, +34 963131893, fundacion_hgv@gva.es
    Scientific contact
    Fundacion Investigación Hospital General Universitario de Valencia, Fundacion Investigación Hospital General Universitario de Valencia, +34 963 131 893, fundacion_hgv@gva.es
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Mar 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    El objetivo principal de este estudio es probar la eficacia de Fluticasona propionato al 0.05% en crema frente placebo (vehículo de la crema) aplicada en las zonas de lesión 2 veces por semana hasta la recidiva o un máximo de 16 semanas para disminuir las recidivas de DA en niños de 2 a 10 años.
    Protection of trial subjects
    No specific measures .
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jan 2010
    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
    Spain: 61
    Worldwide total number of subjects
    61
    EEA total number of subjects
    61
    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)
    61
    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
    -

    Pre-assignment
    Screening details
    A total of 61 patients were assessed for eligibility, ofthese children, seven had failed screening (1 No informed consent; 6 Inclusion/exclusion criterianot met).

    Pre-assignment period milestones
    Number of subjects started
    61
    Number of subjects completed
    54

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    No informed consent: 1
    Reason: Number of subjects
    Inclusion/exclusion criteria not met: 6
    Period 1
    Period 1 title
    Open-label Stabi-lization Phase (OSP)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Open-label Stabi-lization Phase (OSP)
    Arm description
    Children were enrolled into an initial OSP on treatment with twice daily Fruticasone Propionate cream 0.05% up to 2 weeks. Those children who achieved treatment success in OSP entered the DMP.
    Arm type
    Treatment success

    Investigational medicinal product name
    Fluticasone propionate
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Fluticasone propionate cream 0.05% twice daily up to 2 weeks.

    Number of subjects in period 1 [1]
    Open-label Stabi-lization Phase (OSP)
    Started
    54
    Completed
    49
    Not completed
    5
         Adverse event, non-fatal
    1
         Lack of efficacy
    3
         Protocol deviation
    1
    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: A total of 61 patients were assessed for eligibility, of these children, seven had failed screening. Hence, fifty-four patients entered the OSP, of them 49 continued into the DMP and were randomized (twenty six were in the FP group).
    Period 2
    Period 2 title
    Double-blind Maintenance Phase (DMP).
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    Randomization was generated by a random number table;the list was produced by the statistical service of the CRO. A blindedcopy and clinical trial coded medication were received andstored by the clinical trials pharmacist at Consorcio HospitalGeneral Universitario de Valencia (CHGUV). The pharma-cist dispensed the research drugs packs according with theresearch assistants that used consecutively numbered packsto allocate new participants to treatment groups.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fluticasone propionate treatmen
    Arm description
    To receive Fluticasone propionate twice weekly on consecutive days for 16 weeks or at relapse, in which case they were withdrawn from the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Fluticasone propionate
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Fluticasone propionate cream 0.05% twice weekly on consecutive days

    Arm title
    Vehicle treatment
    Arm description
    To receive vehicle (PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans) twice weekly on consecutive days for 16 weeks or at relapse.
    Arm type
    Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    PL1
    Other name
    PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans.
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans, twice weekly on consecutive days.

    Number of subjects in period 2
    Fluticasone propionate treatmen Vehicle treatment
    Started
    26
    23
    Completed
    24
    21
    Not completed
    2
    2
         Consent withdrawn by subject
    -
    1
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label Stabi-lization Phase (OSP)
    Reporting group description
    -

    Reporting group values
    Open-label Stabi-lization Phase (OSP) Total
    Number of subjects
    54 54
    Age categorical
    Units: Subjects
        Children (2-11 years)
    54 54
    Gender categorical
    Units: Subjects
        Female
    29 29
        Male
    25 25

    End points

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    End points reporting groups
    Reporting group title
    Open-label Stabi-lization Phase (OSP)
    Reporting group description
    Children were enrolled into an initial OSP on treatment with twice daily Fruticasone Propionate cream 0.05% up to 2 weeks. Those children who achieved treatment success in OSP entered the DMP.
    Reporting group title
    Fluticasone propionate treatmen
    Reporting group description
    To receive Fluticasone propionate twice weekly on consecutive days for 16 weeks or at relapse, in which case they were withdrawn from the study.

    Reporting group title
    Vehicle treatment
    Reporting group description
    To receive vehicle (PFCO/W Base®- Guinama S.L.U., Propyleneglycol and Aqua conservans) twice weekly on consecutive days for 16 weeks or at relapse.

    Primary: Relapse of Atopic Dermatitis

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    End point title
    Relapse of Atopic Dermatitis
    End point description
    The primary study endpoint was a relapse rate of Atopic Dermatitis, defined as an SCORAD >5 or ≥25% initial SCORAD.
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    Fluticasone propionate treatmen Vehicle treatment
    Number of subjects analysed
    26
    23
    Units: si/no
    7
    13
    Statistical analysis title
    Log Rank
    Statistical analysis description
    Differ-ences between treatment groups were tested using Log Rank (Mantel-Cox).
    Comparison groups
    Fluticasone propionate treatmen v Vehicle treatment
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.05
    Method
    Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Total study period (2 weeks + 16 weeks)
    Adverse event reporting additional description
    Safety was assessed by monitoring adverse events. Causal relationship of the clinical event to the use of the medication studied was assessed by clinical researchers. The adverse cutaneous reactions related with corticosteroid treatment were particularly considered (skin atrophy, telangiectasia, striae and hypertrichosis).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Open-label Stabi-lization Phase (OSP)
    Reporting group description
    -

    Reporting group title
    fluticasone propionate (FP)
    Reporting group description
    -

    Reporting group title
    Vehicle group
    Reporting group description
    -

    Serious adverse events
    Open-label Stabi-lization Phase (OSP) fluticasone propionate (FP) Vehicle group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 26 (3.85%)
    1 / 23 (4.35%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Mastoiditis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 26 (3.85%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
    Additional description: Aphthous stomatitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 26 (3.85%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Open-label Stabi-lization Phase (OSP) fluticasone propionate (FP) Vehicle group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 54 (1.85%)
    8 / 26 (30.77%)
    10 / 23 (43.48%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 26 (7.69%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Wound
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 26 (7.69%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Skin abrasion
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 26 (7.69%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Eczema
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 26 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 26 (15.38%)
    3 / 23 (13.04%)
         occurrences all number
    0
    4
    3
    Tonsillitis
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 26 (11.54%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    2
    Otitis media
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 26 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    0
    4

    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.
    It was prematurely terminated because patient recruitment was very slow and the economic grant had ended, nonetheless the number of recruited patients was enough according to the estimated sample size, so this study can be conclusive with certainty.
    For support, Contact us.
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    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.

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