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    Summary
    EudraCT Number:2011-004370-28
    Sponsor's Protocol Code Number:11-03/FusBet-C
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-01
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004370-28
    A.3Full title of the trial
    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 eczemas.

    Doppelblinde, randomisierte klinische Studie zum Vergleich der Wirksamkeit und Verträglichkeit von
    Fusidinsäure 2% Betamethason 0,1% Creme vs. Fucicort Creme vs. Grundlage bei Patienten mit bakteriell infizierten Ekzemen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to compare two creams with the active substances fusidic acid and betamethasone and one cream without active substance for patients with bacterial infected eczemas.

    Klinische Studie zum Vergleich zweier Cremes mit der Wirkstoffkombination Fusidinsäure und Betamethason und einer Creme ohne Wirkstoff bei Patienten mit bakteriell infizierten Ekzemen.
    A.4.1Sponsor's protocol code number11-03/FusBet-C
    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 SponsorDermapharm AG
    B.1.3.4CountryGermany
    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 supportDermapharm AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDermapharm AG
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressLil-Dagover-Ring 7
    B.5.3.2Town/ cityGrünwald
    B.5.3.3Post code82031
    B.5.3.4CountryGermany
    B.5.4Telephone number004908964186166
    B.5.5Fax number004908964186110
    B.5.6E-mailmarkus.kowasch@dermapharm.de
    D. IMP Identification
    D.IMP: 1
    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 Fucicort Creme
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFucicort Creme
    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 INNBetamethasonvalerat
    D.3.9.1CAS number 2152-44-5
    D.3.9.3Other descriptive nameBETAMETHASONE VALERATE
    D.3.9.4EV Substance CodeSUB00786MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1%
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFUSIDIC ACID
    D.3.9.1CAS number 03/06/6990
    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 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 No
    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 nameFusidinsäure 2% Betamethason 0.1% Creme
    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.3.9.1CAS number 2152-44-5
    D.3.9.3Other descriptive nameBETAMETHASONE VALERATE
    D.3.9.4EV Substance CodeSUB00786MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1%
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFUSIDIC ACID
    D.3.9.1CAS number 03/06/6990
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bacterial infected eczemas
    E.1.1.1Medical condition in easily understood language
    Eczemas with an additional problem: A bacterial infection
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10014199
    E.1.2Term Eczema infected
    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
    Evaluation of the efficacy and safety of a new fusidic acid 2% betamethosone 0.1% cream formulation vs. the originator Fucicort (licensed) vs. vehicle in patients with bacterial infected eczemas.

    See also E5 (endpoints).
    E.2.2Secondary objectives of the trial
    See E5 (endpoints).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Female or male, age at least 18 years
    2) Informed consent prior to study specific actions
    3) Diagnosis "bacterial superinfected eczema" based on the clinical symptoms with at treatment area between at least 5 cm² and 25 cm² at the most
    4) At least a moderate severe disease, that means a SIRS-Score of at least 8 (sum score of 7 clinical paramters: exudate/purulence, crusts, erythema, overwarming, swelling, itching, pain) evaluated on a scale 0-6
    5) Clinical Parameter exudate must be at least "1 =present"
    6) Women of childbearing potential: Use of an efficient contraceptive method (according to guideline CPMP/ICH/286/95) during the study
    7) Women of childbearin potential: Pregnancy test with negativ result prior to therapy start
    E.4Principal exclusion criteria
    1) Bacterial skin infection that can not be treated adequately with topical antibiotics due to its severity or the deepness of infection
    2) Suspicion for additional viral or mycotic infection in the treatment area
    3) Treatment with study medication in the area of the eyes
    4) Systemic treatment with antibiotics within the last 4 weeks prior to study inclusion
    5) Systemic treatment with immunosuppresive medication or corticosteroids within the last 2 weeks prior to study inclusion
    6) Topical treatment of the treatment area (s) within the last week prior to study inclusion
    7) Known intolerance or hypersensitivity against fusidic acid, betamethasone or against any of the other ingredienst of the study medication
    8) Severe actue or chronic concomitant disease seriously affecting the general condition
    9) Concomitant diseases which may -taking the present knwoledge into account- influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
    10) Concomitant medication which may -taking the present knowledge into account- influence the methods of measurement used in this study or the resulting data
    11) Well-founded doubt regarding the cooperation of the patient
    12) Participation in another clinical trial within the last 30 days prior to inclusion or during this study
    13) Former participation in this clinical trial
    14) Pregnancy, planned pregnancy, lactation
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with clinical successful treatment on day 14 (end of treatment).
    Clinical successful treatment means that the symptom exudate/purulence has disapeared completely and the SIRS score is less than 8 and no further treatment of the study indication is necessary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    Score difference of the SIRS parameters in the different treatment groups at therapy start (day 0) and at main examination (day 14)
    Course of all clinical parameters seperately and as sum score from inclusion examination (day 0) to final examination / early study termination
    Clasification of the bacteriological success at end of treatment (day 14) and end of observational phase (day 21)
    Number of patients with relapse / reinfection in the observational phase
    Tolerance analysis:
    Evaluation of tolerance
    Adverse events, focussed on serious and/or unexpected adverse events, discontinuation of study medication due to adverse event, possible causal relation, patients with at least one adverse event, type and number of adverse events according to MedDRA
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depends on the secondary endpoint, see E.5.2 above
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Last Vist Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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 Decision2012-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-22
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