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    Summary
    EudraCT Number:2015-005707-92
    Sponsor's Protocol Code Number:16-03/MicoFlu-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:2016-06-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-005707-92
    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.
    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.4.1Sponsor's protocol code number16-03/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 organisationDermapharm AG
    B.5.2Functional name of contact pointClinical Research 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 number+4989641860
    B.5.5Fax number+498964186110
    B.5.6E-mailGabriele.Bast@dermapharm.de
    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.3.9.1CAS 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.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1255-35-2
    D.3.9.3Other descriptive nameFLUPREDNIDENE ACETATE
    D.3.9.4EV Substance CodeSUB02235MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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.3.4Pharmaceutical form
    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 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.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1255-35-2
    D.3.9.3Other descriptive nameFLUPREDNIDENE ACETATE
    D.3.9.4EV Substance CodeSUB02235MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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 19.0
    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 patient information by the investigator
    • 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 efficient 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 observation 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 (final visit = test-of-cure visit).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at the regular study end, i.e. 7 days after end of treatment (= test-of-cure visit).
    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
    • Number and classification of adverse events
    • Evaluation of tolerability by the investigator and by the patient at all visits under treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Different, 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 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
    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 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.1.3Elderly (>=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 state345
    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 trail Treatment), but normal treatment based on the clinical judgement 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 Decision2016-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
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