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   43865   clinical trials with a EudraCT protocol, of which   7286   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

    Print Download

    Summary
    EudraCT Number:2020-002219-24
    Sponsor's Protocol Code Number:IMPET-001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-002219-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy and Safety of Fusidic Acid Hydrophilic Cream 20 mg/g and Fucidin® Cream in the Treatment of Adult and Pediatric Subjects with Impetigo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy and Safety of Fusidic Acid Hydrophilic Cream 20 mg/g and Fucidin® Cream in the Treatment of Adult and Pediatric Subjects with Impetigo.
    A.3.2Name or abbreviated title of the trial where available
    IMPET
    A.4.1Sponsor's protocol code numberIMPET-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBasic Pharma Technologies
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBasic Pharma Technologies
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAESCULAPE CRO
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressBelseledorp 116
    B.5.3.2Town/ citySint-Niklaas
    B.5.3.3Post code9111
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3249273 59 31
    B.5.6E-mailjpdeslypere@aesculape.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fusidinezuur Basic Pharma 20mg/g crème
    D.2.1.1.2Name of the Marketing Authorisation holderBasic Pharma Manufacturing BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFusidinezuur Basic Pharma 20mg/g crème
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFusidic acid
    D.3.9.1CAS number 6990-06-3
    D.3.9.3Other descriptive nameFUSIDIC ACID
    D.3.9.4EV Substance CodeSUB02292MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Fucidin®
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFucidin®
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFusidic acid
    D.3.9.1CAS number 6990-06-3
    D.3.9.3Other descriptive nameFUSIDIC ACID
    D.3.9.4EV Substance CodeSUB02292MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Impetigo contagiosa
    E.1.1.1Medical condition in easily understood language
    Impetigo
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021531
    E.1.2Term Impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10041923
    E.1.2Term Staphylococcal impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042178
    E.1.2Term Streptococcal impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021535
    E.1.2Term Impetigo NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10041939
    E.1.2Term Staphylococcus aureus impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042200
    E.1.2Term Streptococcus pyogenes impetigo
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10021533
    E.1.2Term Impetigo contagious
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective 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® cream are equivalent in the treatment of impetigo patients.
    This primary efficacy endpoint can be measured by assessing the rate of “cure” after one week of treatment, which will be defined during the first follow up visit.
    E.2.2Secondary objectives of the trial
    1. The rate of “improvement”, and “failure” after one week
    2. The rate of “cure”, “improvement”, and “failure” after two weeks
    3. The rate of bacterial cure (elimination of causative pathogens in persisting lesions or the unavailability of a swab if lesions were cured) after one and two weeks
    4. Safety analysis: comparison of tolerance and adverse event profiles
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects having a clinical diagnosis of localized impetigo contagiosa (not the extensive forms)
    2. Skin Infection Score: more than 7 points
    3. Subject age: ≥18 months of age
    4. Subject (and/or parent or legal guardian) is willing to comply with the protocol, remain available for follow up visits, and provide informed consent
    E.4Principal exclusion criteria
    If a subject meets one of the stated exclusion criteria, he/she cannot participate in this study. The exclusion criteria will apply to all subjects at all study visits.

    1. Subjects for whom no signed and dated informed consent is obtained
    2. Subjects whose temperature is >38.5°C (higher than low grade fever)
    3. Subjects who have extensive forms of impetigo, defined as:
    • More than 10 lesions
    • Total affected area >100 cm2
    • The surrounding redness extends >2 cm from the edge of the lesions
    4. Subjects with secondary impetigo, where the infection is secondary to some other underlying skin disease
    5. Subjects that have used other medications or treatments prior to enrollment in the study, including:
    • For 24 hours prior to entry: subjects should not have been treated with topical steroids, topical retinoids, topical antibiotics or other ingredients considered as antibacterial, such as salicylic acid
    • For 1 week prior to entry: subjects should not have utilized medicated shampoos or medicated cleansers of any type. Non-medicated cleansers and emollients are permitted at the discretion of the investigator
    • For 1 month prior to entry: subjects should not have been treated with UV-lamp irradiation, oral antibiotics or parenteral corticosteroids
    6. Subjects who have other significant skin infections, diseases or disorders of the skin, including:
    • Systemic erythema (skin redness), not related to impetigo
    • Psoriasis
    • Allergic rashes
    • Viral or fungal infections of the skin
    • Eczema
    • Contact dermatitis
    • Herpes simplex virus
    • Discoid lupus
    • Scabies
    • Necrotizing fasciitis
    • Other significant diseases of the skin
    7. Subjects with a recent history of other severe systemic diseases within 3 months prior to enrollment, including:
    • Severely impaired liver or renal function
    • Severe cardiovascular disease
    • Severe neurological disease
    • Immunocompromised patient
    • Severe disease that may interfere with the study evaluations
    8. Subjects with a serious disease that potentially could be life threatening (including laboratory testing results) or that may interfere with the objective of the study, according to the opinion of the investigator
    9. Subjects requiring any significant concomitant medication that may affect the results of the study
    10. Subjects with sunburn and those who may experience considerable exposure to sunlight during the study period (including UV lamps)
    11. Subjects who have a history of hypersensitivity to fusidic acid or to any other component of the study medication
    12. Pregnant subjects, female subjects planning pregnancy during the study and breast- feeding subjects
    13. Subjects that participated in another clinical study within 3 months prior to the enrolment
    14. Subjects who are considered as unreliable or unlikely to be available during the study
    15. Subjects that previously participated in the present trial
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is clinical efficacy, which will be assessed at the follow up visit after 7 days. For the determination of this clinical efficacy, the overall impetigo condition will be assessed.

    The supposition in planning the study is that Fusidic acid hydrophilic cream 20 mg/g will possess similar efficacy and tolerability/safety to the Fucidin® cream, since the two products are similarly formulated and the dose regimen, duration, study population and study design are all very similar to those used in the previous Koning et al. 2002 study. Given these facts, it will be very unlikely that Fusidic acid hydrophilic cream 20 mg/g will prove clinically superior to Fucidin® cream in either efficacy or tolerability. Therefore, the important objective in the present study is to demonstrate that the Fusidic acid hydrophilic cream 20 mg/g is not clinically inferior by a prespecified amount to Fucidin® cream, since in practice, these products are intended to be interchangeable.
    Fusidic acid hydrophilic cream (Basic Pharma Technologies) and comparing it to the rate of “cure” after one week of treatment with Fucidin® cream (Leo Pharma).
    Four possible endpoints are described:
    1. Cured: defined as the complete absence of lesions or the lesions have become dry and without crusts. Remaining local erythema of the intact skin or such progress that no further antibiotic therapy is needed, is acceptable as well.
    2. Improvement: defined as a decline in the affected area, number of lesions or in both, as compared to a previous visit (additional antibiotic therapy is still required).
    3. Failure: insufficient improvement or deterioration (e.g. lesions remain crusted and/or have exudate, lesions have a yellow/honey colored crust or the area increases with or without an increase in the number of lesions), as compared to a previous visit (additional antibiotic therapy is required).
    4. Unable to determine: the effect of the treatment is not assessable (e.g. subjects who refused informed consent or who are unable to follow up).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week
    E.5.2Secondary end point(s)
    1. The rate of “improvement”, and “failure” after one week
    2. The rate of “cure”, “improvement”, and “failure” after two weeks
    3. The rate of bacterial cure (elimination of causative pathogens in persisting lesions or the unavailability of a swab if lesions were cured) after one and two weeks
    4. Safety analysis: comparison of tolerance and adverse event profiles
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week, 2 weeks.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Fucidin cream
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    There is an ICF for the impartial witness/interpreter if the patient is illiterate, non-writing or a non-Hungarian/-Dutch/-English or -French speaker + an ICF for children and for parents or legal representatives of the children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-17
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-20
    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-Mon Apr 29 15:43:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA