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    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.
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    Summary
    EudraCT Number:2018-001633-41
    Sponsor's Protocol Code Number:18-01/Cic-C
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-10
    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 number2018-001633-41
    A.3Full title of the trial
    Double-blind, randomised clinical study comparing efficacy and safety of Ciclopirox Olamine Cream 10 mg/g (Test) vs. Batrafen® Cream (Reference) vs. Vehicle in patients with skin mycoses
    Doppelblinde, randomisierte, klinische Studie zum Vergleich von Wirksamkeit und Verträglichkeit von Ciclopiroxolamin Creme (10 mg/g) (Test) mit Batrafen® Creme (Referenz) und mit der Grundlage an Patienten mit Hautmykosen
    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 substance Ciclopirox Olamine and one cream without active substance for patients with skin mycoses
    Klinische Studie zum Vergleich zweier Cremes mit dem aktiven Wirkstoff Ciclopiroxolamin und einer Creme ohne aktivem Wirkstoff für Patienten mit Hautmykosen
    A.4.1Sponsor's protocol code number18-01/Cic-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 number004989641860
    B.5.5Fax number00498964186110
    B.5.6E-mailClinicaltrials.Dermapharm@dermapharm.com
    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 Batrafen® Creme 10 mg/g
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland 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 nameBatrafen® Creme 10 mg/g
    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 INNCiclopirox olamine
    D.3.9.1CAS number 41621-49-2
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameCICLOPIROX OLAMINE
    D.3.9.4EV Substance CodeSUB01294MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 nameCiclopiroxolamin (10 mg/g)
    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 INNCiclopirox olamine
    D.3.9.1CAS number 41621-49-2
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameCICLOPIROX OLAMINE
    D.3.9.4EV Substance CodeSUB01294MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    dermatomycoses
    Hautmykosen
    E.1.1.1Medical condition in easily understood language
    Skin diseases caused by a fungus
    Pilzerkrankungen der Haut
    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 10012502
    E.1.2Term Dermatomycosis, unspecified
    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
    Evaluation of the efficiacy and safety of a new creme containing 10 mg/g Ciclopirox Olamine vs. the originator Batrafen® Cream (Reference) vs. vehicle in patients with skin mycoses
    Evaluierung der Wirksamkeit und Verträglichkeit einer neuen Creme mit Ciclopiroxolamin 10 mg/g vs. dem Referenzprodukt Batrafen® Creme vs. Placebo in Patienten mit Hautmykosen
    E.2.2Secondary objectives of the trial
    see E5 (endpoints)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women and men with ≥ 18 years of age
    • Written informed consent to study participation after verbal and comprehensive information through the investigator
    • Diagnosis of skin mycosis confirmed by a positive microscopic native preparation in 30 % potassium hydroxide (KOH)
    • At least moderate severity of skin mycosis, e.g. the severity of the clinical parameters pruritus, burning/stinging, erythema, fissuring/cracking, scaling, and maceration need to sum up to a total score value of ≥ 6 or more, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity).
    • For women of childbearing potential : Application of an efficient contraceptive method during the whole study
    • For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start
    E.4Principal exclusion criteria
    • Presence of large-sized and scattered, or deeply embedded skin mycosis which would require systemic treatment with antimycotics
    • Necessity of application of the study medication in the area around the eyes
    • Known intolerance or hypersensitivity against ciclopirox olamine or any of the other ingredients in the study medication
    • Local treatment in the test area during the last 7 days prior study inclusion
    • Systemic treatment with antimycotics or glucorticoids within the last 4 weeks prior to study inclusion
    • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
    • 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
    • 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)
    Primary efficacy variable to be analysed is the proportion of patients with clinical success at EOT (Day 21 ± 3) defined as a negative mycological culture and a clinically successful treatment defined as total score value (sum of individual scores) of all clinical parameters of not more than 2 and no single parameter with a score value of more than 1 and no further need for antimycotical treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment (Day 21 ± 3)
    E.5.2Secondary end point(s)
    • Changes of the score value of the individual clinical symptoms pruritus, burning/stinging, erythema, fissuring/cracking, scaling, and maceration between baseline (Day 0) and week 3 (Day 21 ± 3, EOT) and week 5 (Day 35 ± 5)
    • Proportion of patients with negative mycological culture at EOT (Day 21 ± 3) and after follow up at week 5 (Day 35 ± 5)
    • Proportion of patients clinically improved at EOT (Day 21 ± 3) and at week 5 (Day 35 ± 5) to a total score value of not more than 2 and no single parameter with a score value of more than 1
    • Evaluation of Overall Therapeutic Success by the investigator and patient at the final examination at week 5 (Day 35 ± 5)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depends on the secondary 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 concerned15
    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 visit last subject (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: 399
    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 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 state399
    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 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 Decision2019-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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