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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39229   clinical trials with a EudraCT protocol, of which   6426   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).
     
    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:2019-001010-42
    Sponsor's Protocol Code Number:19-01/MicoFlu-C
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-12
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-001010-42
    A.3Full title of the trial
    Double-blind, randomised clinical study comparing efficacy and safety of Miconazole 2%_Fluprednidene 0.1% Cream (Test) vs. Vobaderm® Cream (Reference) vs. Vehicle in patients with moderate to severely inflamed candidiasis of the skin
    Dvojitě zaslepené, randomizované klinické hodnocení porovnávající účinnost a bezpečnost krému s miconazolem (2%) a fluprednidenem (0.1%) jako hodnoceného přípravku, krému Vobaderm® jako komparátoru a vehikula u pacientů se střední až závažnou kandidózou kůže
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to compare the therapeutic effects of two creams with the
    active substances miconazole and fluprednidene and of one cream without
    active substance for patients with moderate to severely inflamed infection
    of the skin through yeast fungi
    A.3.2Name or abbreviated title of the trial where available
    MicoFlu-C
    A.4.1Sponsor's protocol code number19-01/MicoFlu-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 organisationProinnovera GmbH
    B.5.2Functional name of contact pointClinical Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressWienburgstraße 207
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48159
    B.5.3.4CountryGermany
    B.5.4Telephone number0049251270778123
    B.5.5Fax number00492512707786123
    B.5.6E-mailjens.grosenick@proinnovera.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 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 nameMiconazole 2%_Fluprednidene 0.1%
    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 INNmiconazole nitrate
    D.3.9.1CAS number 22832-87-7
    D.3.9.3Other descriptive namemiconazole nitrate
    D.3.9.4EV Substance CodeSUB03285MIG
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluprednidene acetate
    D.3.9.1CAS number 1255-35-2
    D.3.9.3Other descriptive namefluprednidene-21-acetate
    D.3.9.4EV Substance CodeSUB02235MIG
    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.3.11 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 Vobaderm
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall Hermal 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 nameVobaderm 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 INNmiconazole nitrate
    D.3.9.1CAS number 22832-87-7
    D.3.9.3Other descriptive namemiconazole nitrate
    D.3.9.4EV Substance CodeSUB03285MIG
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluprednidene acetate
    D.3.9.1CAS number 1255-35-2
    D.3.9.3Other descriptive namefluprednidene-21-acetate
    D.3.9.4EV Substance CodeSUB02235MIG
    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.3.11 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
    moderate to severely inflamed candidiasis of the skin
    E.1.1.1Medical condition in easily understood language
    moderate to severely inflamed infection of the skin through yeast fungi
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007159
    E.1.2Term Candidiasis of skin and nails
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of efficacy and safety of a new cream with miconazole 2 %
    and fluprednidene 0.1 % in comparison with the approved preparation
    Vobaderm® Cream and the underlying vehicle in patients with
    moderately to severely inflamed candidiasis of the skin.
    See also E5 (endpoints)
    E.2.2Secondary objectives of the trial
    See also E5 (endpoints)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women and men ≥ 18 years of age
    • Written consent to study participation after thorough information of the patient through the investigator or another medical competent member of the study team
    • Diagnosis of candidiasis of the skin based on clinical symptoms
    • Positive mycological result of a swab revealing at least a moderate
    number of fungi, microscopically proven
    • Sum score of all clinical parameters (erythema, exudation,
    dysesthesia/ burning, maceration) ≥ 7
    • At least moderate severity of inflammation parameters erythema and
    exudation (i.e. score value ≥ 2)
    • For women of childbearing potential: Application of an highly effective contraceptive method, during the whole study
    • For women of childbearing potential: Pregnancy test with negative
    result prior to study start
    E.4Principal exclusion criteria
    • The treatment area exceeds 10% of the body surface
    • Topical treatment in the treatment area during the last 7 days prior
    to study inclusion
    • Presence of any of the following skin conditions in the treatment area:
    viral infections (e.g. herpes simplex, herpes zoster), lues or tuberculosis
    of the skin, inoculation reactions, rosacea or rosacea-like dermatitis,
    perioral dermatitis, acne, primary purulent skin infections (like e.g.
    folliculitis), atrophied skin, wounds, ulceration
    • Necessity of application of the study medication in the area around the
    eyes
    • Necessity of application of the study medication on mucous
    membranes
    • Systemic treatment with antimycotics and/or glucocorticoids within
    the last 4 weeks prior to study inclusion
    • Known intolerance or hypersensitivity against miconazole (nitrate) or
    other imidazole antimycotics, fluprednidene 21-acetate, or any of the
    other ingredients in the study medications
    • Other severe acute or chronic concomitant disease with severe
    impairment of the general condition
    • Other concomitant diseases which may - taking the present knowledge
    into account - influence the parameters evaluated in the study in a way
    that an objective evaluation would be impossible
    • Other concomitant medication which may - taking the present
    knowledge into account - influence the methods of measurement used in
    this study or the resulting data
    • Reasonable doubt concerning the co-operation of the patient
    • Participation in another clinical study within the last 30 days prior to
    inclusion in this study
    • Participation in this study at an earlier date
    • Women with existing or intended pregnancy or during lactation
    E.5 End points
    E.5.1Primary end point(s)
    Number (percentage) of patients with treatment success (defined as sum score of clinical parameters ≤ 2 and all individual score values ≤ 1 and negative mycological result) at the main examination (EOT = visit 3, after 14 days).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at the end of treatment (main examination = visit 3, after 14+/- 2 days).
    E.5.2Secondary end point(s)
    • Change of the clinical symptom score between visits, and between EOT
    and final examination
    • Number (percentage) of patients with mycological success at EOT and
    at the final visit
    • Evaluation of therapeutic success at EOT by the investigator and by the
    patient
    • Evaluation of overall therapeutic success by the investigator at the
    final examination visit
    • Number (percentage) of patients with clinical relapse / re-infection at
    the final examination visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    depending on the endpoint, see E.5.2.
    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 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 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
    LVLS
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    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 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 state276
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 552
    F.4.2.2In the whole clinical trial 552
    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 (no post-trial treatment), but normal treatment based on the clinical judgment of the investigator.
    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 Decision2019-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA