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    Clinical Trial Results:
    A comparison of the clinical efficacies of Fusidic acid hydrophilic cream 20 mg/g and Fucidin in the treatment of adult and paediatric patients with impetigo

    Summary
    EudraCT number
    2006-002528-41
    Trial protocol
    NL   BE  
    Global end of trial date
    13 Aug 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BPT05-641
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Interdos Pharma bv
    Sponsor organisation address
    Burgemeester Lemmensstraat 352, Geleen, Netherlands, 6163JT
    Public contact
    Jos Wesselman, Interdos, +31 882554010, j.wesselman@basicpharma.nl
    Scientific contact
    Jos Wesselman, Interdos, +31 882554010, j.wesselman@basicpharma.nl
    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 Aug 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this study is to assess whether the clinical efficacy and safety of Fusidic acid hydrophilic cream 20 mg/g, manufactured by Basic Pharma Manufacturing bv, and Fucidin are equivalent in a 7-day treatment of impetigo in adult and paediatric subjects. Primary outcome: cure after 1 week. Cure is defined as the complete absence of lesions or the lesions having become dry and without crusts; remaining local erythema of the intact skin is acceptable.
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Sep 2006
    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
    Netherlands: 92
    Country: Number of subjects enrolled
    Belgium: 69
    Country: Number of subjects enrolled
    Serbia: 15
    Worldwide total number of subjects
    176
    EEA total number of subjects
    161
    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)
    3
    Children (2-11 years)
    66
    Adolescents (12-17 years)
    33
    Adults (18-64 years)
    63
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment: The Netherlands: 11 September 2006 - 10 April 2009 Belgium: 18 December 2007 - 23 July 2009 Serbia: 06 February 2009 - 30 July 2009

    Pre-assignment
    Screening details
    Not applicable. Patients with impetigo who are visiting the investigator and who comply with the inclusion criteria were be asked to participate in the study.

    Period 1
    Period 1 title
    Overal trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Reference product (cream) was repacked in blank tubes

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fusidic acid hydrophilic cream 20 mg/g
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Fusidic acid hydrophilic cream 20 mg/g
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    It was not possible to establish a predefined amount of study cream that should be applied to the affected skin, because it depends on a number of variables such as number of skin lesions, size (surface area) of the lesions, location of the lesions, and age of the subject. It was left to the medical judgement of the investigator to establish the amount of cream required for a proper treatment of each patient. The investigators and patients were provided with dosing cards, adapted from the innovator’s website, in order to assist the investigators in the determination and communication of the amount of study cream that should be applied, and in an effort to standardize the procedure of determining the dose of study medication. The dose is given in terms of finger tip units. One finger tip unit is: One full finger tip of cream, this equals approximately 0.5 gram

    Arm title
    Fucidin® cream
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Fucidin® cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    It was not possible to establish a predefined amount of study cream that should be applied to the affected skin, because it depends on a number of variables such as number of skin lesions, size (surface area) of the lesions, location of the lesions, and age of the subject. It was left to the medical judgement of the investigator to establish the amount of cream required for a proper treatment of each patient. The investigators and patients were provided with dosing cards, adapted from the innovator’s website, in order to assist the investigators in the determination and communication of the amount of study cream that should be applied, and in an effort to standardize the procedure of determining the dose of study medication. The dose is given in terms of finger tip units. One finger tip unit is: One full finger tip of cream, this equals approximately 0.5 gram

    Number of subjects in period 1
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Started
    85
    91
    Completed
    76
    81
    Not completed
    9
    10
         Treatment failure
    2
    -
         Adverse event, non-fatal
    -
    2
         violation inclusion criteria
    -
    1
         Lost to follow-up
    7
    6
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fusidic acid hydrophilic cream 20 mg/g
    Reporting group description
    -

    Reporting group title
    Fucidin® cream
    Reporting group description
    -

    Reporting group values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream Total
    Number of subjects
    85 91 176
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    1 2 3
        Children (2-11 years)
    34 32 66
        Adolescents (12-17 years)
    17 16 33
        Adults (18-64 years)
    27 36 63
        From 65-84 years
    6 5 11
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    50 42 92
        Male
    35 49 84

    End points

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    End points reporting groups
    Reporting group title
    Fusidic acid hydrophilic cream 20 mg/g
    Reporting group description
    -

    Reporting group title
    Fucidin® cream
    Reporting group description
    -

    Primary: “cure” at week one

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    End point title
    “cure” at week one
    End point description
    End point type
    Primary
    End point timeframe
    1 week
    End point values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Number of subjects analysed
    85
    87
    Units: number of subjects
    55
    54
    Attachments
    Cure at one week
    Statistical analysis title
    Non-inferiority analysis for "cure" at one week
    Statistical analysis description
    This will be a double-blind non-inferiority trial aimed to demonstrate that the test cream is as effective the reference cream (Fucidin® cream). For this purpose it is assumed that a demonstration that 50% or more of the efficacy of fusidic acid versus placebo is maintained will suffice to accept non-inferiority. The primary efficacy analysis is the rate of “Cure” at one week. Previous studies demonstrated that with placebo the rate of cure was 13% at this point in time, versus 55% with the appl
    Comparison groups
    Fusidic acid hydrophilic cream 20 mg/g v Fucidin® cream
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    proportion cured at one week
    Point estimate
    0.975
    Confidence interval
         level
    95%
         sides
    1-sided
         lower limit
    0.2
         upper limit
    -

    Secondary: “cure” at week two

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    End point title
    “cure” at week two
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Number of subjects analysed
    85
    88
    Units: number of subjects
    74
    77
    Attachments
    Cure at two weeks
    No statistical analyses for this end point

    Secondary: bacterial cure at week one

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    End point title
    bacterial cure at week one
    End point description
    End point type
    Secondary
    End point timeframe
    1 week
    End point values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Number of subjects analysed
    75
    79
    Units: number of subjects
    60
    62
    No statistical analyses for this end point

    Secondary: bacterial cure at week two

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    End point title
    bacterial cure at week two
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Number of subjects analysed
    80
    82
    Units: number of subjects
    76
    77
    No statistical analyses for this end point

    Secondary: "Improvement" at week one

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    End point title
    "Improvement" at week one
    End point description
    End point type
    Secondary
    End point timeframe
    1 week
    End point values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Number of subjects analysed
    85
    87
    Units: number of subjects
    26
    29
    No statistical analyses for this end point

    Secondary: "Failure" at week one

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    End point title
    "Failure" at week one
    End point description
    End point type
    Secondary
    End point timeframe
    1 week
    End point values
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Number of subjects analysed
    85
    87
    Units: number of subjects
    4
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 week, 2 weeks
    Adverse event reporting additional description
    Adverse events are collected during the follow-up visits after 1 week and after 2 weeks, and reported in the Case Report Forms.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    Fusidic acid hydrophilic cream 20 mg/g
    Reporting group description
    -

    Reporting group title
    Fucidin® cream
    Reporting group description
    -

    Serious adverse events
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 90 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Fusidic acid hydrophilic cream 20 mg/g Fucidin® cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 85 (4.71%)
    10 / 90 (11.11%)
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 90 (1.11%)
         occurrences all number
    1
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 90 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Infections and infestations
    Lung infection
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 90 (1.11%)
         occurrences all number
    0
    1

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/11809642
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