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    Clinical Trial Results:
    Double-blind, randomized clinical trial to compare the efficacy and safety of fusidic acid 2% betamethasone 0,1% cream vs. Fucicort cream vs. vehicle for patients with bacterial infected eczema

    These results have been removed from public view whilst they are reviewed and may need to be corrected before being returned to public view
    Summary
    EudraCT number
    2011-004370-28
    Trial protocol
    DE  
    Global end of trial date
    26 Jun 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Feb 2016
    First version publication date
    14 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    11-03/FusBet-C
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover-Ring 7, Gruenwald, Germany, 82031
    Public contact
    Head of clinical department, Dermapharm AG, 0049 08964186-0,
    Scientific contact
    Head of clinical department, Dermapharm AG, 0049 08964186-0,
    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
    13 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    evaluation of the efficacy and safety of a new fusidic acid 2% betamethasone 0.1% cream vs. the originator Fucicort cream (licensed) vs. vehicle in patients with bacterial infected eczema
    Protection of trial subjects
    There were no specific measures necessary.
    Background therapy
    There was no background therapy.
    Evidence for comparator
    The trial aimed to show non-inferiority with regard to the comparator in order to obtain a generic marketing authorization for the test product.
    Actual start date of recruitment
    21 Aug 2012
    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
    Germany: 400
    Worldwide total number of subjects
    400
    EEA total number of subjects
    400
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    317
    From 65 to 84 years
    78
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    all study centers in Germany; first patient first visit: 07 September 2012; last patient last visit: 26 June 2014

    Pre-assignment
    Screening details
    Main criteria for inclusion: women and men ≥ 18 years of age; diagnosis of “bacterial super-infected eczema” based on clinical symptoms in a treatment area between 5 and 25 cm²; at least moderately severe clinical picture with presence of the clinical parameter “exudate/pus”

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    All study preparations were indistinguishable in terms of appearance and were filled in white tubes of identical appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    FusBet Cream
    Arm description
    Test product
    Arm type
    Experimental

    Investigational medicinal product name
    Fusidic acid 2%_betamethasone 0.1% cream
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily on the affected area of the skin.

    Arm title
    Fucicort Cream
    Arm description
    Reference product
    Arm type
    Active comparator

    Investigational medicinal product name
    Fucicort
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily on the affected area of the skin.

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily on the affected area of the skin.

    Number of subjects in period 1
    FusBet Cream Fucicort Cream Vehicle
    Started
    161
    158
    81
    Completed
    150
    149
    72
    Not completed
    11
    9
    9
         Lack of efficacy
    4
    4
    8
         Adverse event, non-fatal
    1
    -
    -
         Consent withdrawn by subject
    -
    1
    -
         Lost to follow-up
    6
    4
    1
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    No treatment in the follow-up period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    FusBet Cream
    Arm description
    Test product
    Arm type
    Experimental

    Investigational medicinal product name
    Fusidic acid 2%_betamethasone 0.1% cream
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Application twice daily at the affected area of the skin.

    Arm title
    Fucicort Cream
    Arm description
    Reference product
    Arm type
    Active comparator

    Investigational medicinal product name
    Fucicort
    Investigational medicinal product code
    D07CC01
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily on the affected area of the skin.

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily on the affected area of the skin.

    Number of subjects in period 2
    FusBet Cream Fucicort Cream Vehicle
    Started
    150
    149
    72
    Completed
    146
    144
    64
    Not completed
    4
    5
    8
         Technical-logistic reasons
    -
    -
    1
         Lack of efficacy
    2
    1
    6
         Consent withdrawn by subject
    -
    2
    1
         Lost to follow-up
    2
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    -

    Reporting group values
    Treatment Period Total
    Number of subjects
    400 400
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    317 317
        From 65-84 years
    78 78
        85 years and over
    5 5
    Gender categorical
    Units: Subjects
        Female
    173 173
        Male
    227 227
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    includes all patients of the safety data set who comply with the study diagnosis (according to the associated inclusion criterion) and provide the baseline value and at least one post baseline value under treatment

    Subject analysis set title
    PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    includes all patients of the ITT data set who do not exhibit any major protocol violations

    Subject analysis set title
    Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once

    Subject analysis sets values
    ITT PP Safety
    Number of subjects
    392
    359
    394
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    309
    282
    311
        From 65-84 years
    78
    72
    78
        85 years and over
    5
    5
    5
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    170
    154
    171
        Male
    222
    205
    223

    End points

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    End points reporting groups
    Reporting group title
    FusBet Cream
    Reporting group description
    Test product

    Reporting group title
    Fucicort Cream
    Reporting group description
    Reference product

    Reporting group title
    Vehicle
    Reporting group description
    -
    Reporting group title
    FusBet Cream
    Reporting group description
    Test product

    Reporting group title
    Fucicort Cream
    Reporting group description
    Reference product

    Reporting group title
    Vehicle
    Reporting group description
    -

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    includes all patients of the safety data set who comply with the study diagnosis (according to the associated inclusion criterion) and provide the baseline value and at least one post baseline value under treatment

    Subject analysis set title
    PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    includes all patients of the ITT data set who do not exhibit any major protocol violations

    Subject analysis set title
    Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once

    Primary: Treatment effect

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    End point title
    Treatment effect [1]
    End point description
    Number (percentage) of patients with "clinical treatment success" according to predefined criteria at end of treatment
    End point type
    Primary
    End point timeframe
    start of treatment (visit 1) and end of treatment (visit 3)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The orimary goal of this trial was to show non-inferiority of the test to the reference product. The vehicle arm served as verification of the assay sensitivity. The three end point tests had to be done separately in order to avoid the otherwise necessary adjustment of the significance levels.
    End point values
    FusBet Cream Fucicort Cream ITT PP
    Number of subjects analysed
    142
    144
    311
    286
    Units: Number
    122
    109
    249
    231
    Statistical analysis title
    Analysis of efficacy
    Statistical analysis description
    Non-inferiority test (one-sided test) with alpha = 0.025 and beta = 0.20, based on the PP data set. The Non-Inferiority limit was set to 0.1 (= 10%)
    Comparison groups
    FusBet Cream v Fucicort Cream
    Number of subjects included in analysis
    286
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.1022
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.0048
         upper limit
    0.1997

    Other pre-specified: Superiority of Test over Vehicle

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    End point title
    Superiority of Test over Vehicle [2]
    End point description
    Number (percentage) of patients with "clinical treatment success" according to predefined criteria at end of treatment
    End point type
    Other pre-specified
    End point timeframe
    start of treatment (visit 1) and end of treatment (visit 3)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis for this end point served as verification of the assay sensitivity and had to be done individually for each active preparation in accordance with CPMP/EWP/908/99.
    End point values
    FusBet Cream Vehicle ITT
    Number of subjects analysed
    157
    81
    392
    Units: Number
    133
    46
    295
    Statistical analysis title
    Sensitivity analysis
    Statistical analysis description
    Superiority of Test over Vehicle for the primary efficacy variable
    Comparison groups
    FusBet Cream v Vehicle
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Fisher exact
    Confidence interval

    Other pre-specified: Superiority of Reference over Vehicle

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    End point title
    Superiority of Reference over Vehicle [3]
    End point description
    Number (percentage) of patients with "clinical treatment success" according to predefined criteria at end of treatment
    End point type
    Other pre-specified
    End point timeframe
    start of treatment (visit 1) and end of treatment (visit 3)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis for this end point served as verification of the assay sensitivity and had to be done individually for each active preparation in accordance with CPMP/EWP/908/99.
    End point values
    Fucicort Cream Vehicle ITT
    Number of subjects analysed
    154
    81
    392
    Units: Number
    116
    46
    295
    Statistical analysis title
    Sensitivity analysis
    Statistical analysis description
    Superiority of Reference over Vehicle for the primary efficacy variable
    Comparison groups
    Fucicort Cream v Vehicle
    Number of subjects included in analysis
    235
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0047
    Method
    Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the inclusion visit (visit 1) to the final visit (visit 4)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    FusBet Cream
    Reporting group description
    treatment arm with test product

    Reporting group title
    Fucicort Cream
    Reporting group description
    treatment arm with reference product

    Reporting group title
    Vehicle
    Reporting group description
    treatment arm with placebo

    Serious adverse events
    FusBet Cream Fucicort Cream Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 158 (0.00%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    FusBet Cream Fucicort Cream Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 158 (6.33%)
    7 / 155 (4.52%)
    4 / 81 (4.94%)
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 158 (0.00%)
    0 / 155 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Rib fracture
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Surgical and medical procedures
    Skin neoplasm excision
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 155 (0.65%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 155 (0.65%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 155 (0.65%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    1
    Dermatitis atopic
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 158 (0.00%)
    2 / 155 (1.29%)
    0 / 81 (0.00%)
         occurrences all number
    0
    2
    0
    Solar dermatitis
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Osteitis
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 155 (0.65%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival abscess
         subjects affected / exposed
    0 / 158 (0.00%)
    0 / 155 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 158 (1.27%)
    1 / 155 (0.65%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    1
    Superinfection
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea pedis
         subjects affected / exposed
    1 / 158 (0.63%)
    0 / 155 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Viral rash
         subjects affected / exposed
    0 / 158 (0.00%)
    1 / 155 (0.65%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0

    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.
    None reported
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