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    Summary
    EudraCT Number:2015-001237-24
    Sponsor's Protocol Code Number:RD.03.SPR.105082
    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:2015-06-26
    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 number2015-001237-24
    A.3Full title of the trial
    Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Ciclopoli® Nail Lacquer.
    Therapietreue und Zufriedenheit der Patienten bei der Behandlung von Nagelpilz mit Loceryl® Nagellack 5% gegenüber Ciclopoli® Nagellack
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Ciclopoli® Nail Lacquer.
    Therapietreue und Zufriedenheit der Patienten bei der Behandlung von Nagelpilz mit Loceryl® Nagellack 5% gegenüber Ciclopoli® Nagellack
    A.4.1Sponsor's protocol code numberRD.03.SPR.105082
    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 SponsorGalderma R&D
    B.1.3.4CountryFrance
    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 supportGalderma R&D
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalderma R&D
    B.5.2Functional name of contact pointFarzaneh Sidou
    B.5.3 Address:
    B.5.3.1Street AddressLes Templiers 2400 Route des Colles
    B.5.3.2Town/ cityBiot
    B.5.3.3Post code06410
    B.5.3.4CountryFrance
    B.5.4Telephone number0033493957051
    B.5.5Fax number0033492952083
    B.5.6E-mailFarzaneh.sidou@galderma.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 Loceryl® Nail Lacquer
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma R&D
    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 nameLoceryl® Nail Lacquer
    D.3.4Pharmaceutical form Medicated nail lacquer
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOROLFINE HYDROCHLORIDE
    D.3.9.1CAS number 78613-38-4
    D.3.9.4EV Substance CodeSUB00500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Ciclopoli® Nail Lacquer
    D.2.1.1.2Name of the Marketing Authorisation holder63359.00.00
    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 nameCiclopoli® Nail Lacquer
    D.3.4Pharmaceutical form Medicated nail lacquer
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOPIROX OLAMINE
    D.3.9.1CAS number 29342-05.0
    D.3.9.4EV Substance CodeSUB01294MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    Toenail Distal and Lateral Subungual Onychomycosis
    Distale und laterale subunguale Onychomykose der Zehennägel
    E.1.1.1Medical condition in easily understood language
    Toenail Distal and Lateral Subungual Onychomycosis
    Distale und laterale subunguale Onychomykose der Zehennägel
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10030338
    E.1.2Term Onychomycosis
    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 main objective of this study is to compare subject-reported adherence and satisfaction for two modes of treatment of Distal and Lateral Subungual Onychomycosis (DLSO) with Loceryl® Nail Lacquer (Amorolfine) and Ciclopoli® Nail Lacquer (Ciclopirox) in toenails.
    Das Hauptziel dieser Studie ist es, die Patiententreue und Zufriedenheit zweier Behandlungsarten der distalen und lateralen subungualen Onychomykose von Zehennägeln mit Loceryl® Nagellack und Ciclopoli® Nagellack zu vergleichen.
    E.2.2Secondary objectives of the trial
    Subject safety and satisfaction
    Patientensicherheit und Zurfriedenheit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA
    In general, the investigator will enrol subjects with heterogeneous disease characteristics regarding affected toenails within the limits defined below.

    1. Male or female subjects aged 18 years or older,
    2. Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit,
    3. Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
    4. Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
    5. Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline. The exams will be performed by the Mycological Laboratory as usual in routine practice,
    6. Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline must use an effective method of contraception during the study: oral/systemic (injectable, patch, etc. contraception must have been on a stable dose for 3 months prior to study entry), bilateral Tubal Ligation, hormonal Intra-Uterine Device IUD (inserted at least 1 month prior to screening), strict abstinence,or partner had a vasectomy,
    7. Females of non-childbearing potential, defined as post-menopausal (absence of menstrual bleeding for 1 year), hysterectomy, or bilateral oophorectomy,
    8. Subjects must understand, sign and receive a copy of an informed consent at Screening prior to any investigational procedure being performed,
    9. Subjects must be able and willing to cooperate to the extent and degree required by the protocol (including refraining from using cosmetic nail products on the affected toenails during the study).
    EINSCHLUSSKRITERIEN
    Im Allgemeinen kann der Prüfarzt Studienpatienten mit heterogenem Krankheitsausprägungen in Bezug auf die betroffenen Zehennägel einschließen, die den folgenden definierten Grenzen entsprechen.

    1. Männliche oder weibliche Studienpatienten 18 Jahre oder älter ,
    2. Studienpatienten mit klinischer distaler und lateraler subungualer Onychomykose mindestens eines Zehennagels an jedem Fuß aufgrund von Dermatophyten und/oder Hefe (Candida eingeschlossen) zur Screening Visite.
    3. Studienpatienten mit weniger als 80% erkrankter Nageloberfläche und ohne Einbeziehung der Nagelwurzel, keine Dermatophytose, Streifen (Stacheln) oder subunguale Hyperkeratose > 2mm,
    4. Studienpatienten sollen eine gleiche Anzahl betroffener Zehennägel an beiden Füßen haben oder nicht mehr als einen zusätzlichen betroffenen Zehennagel an einem der Füße,
    5. Studienpatienten mit positivem mykologischem Ergebnis (direkte Mikroskopie und Kultur) für Dermatophyten und/oder Hefe (einschließlich Candida) zur Baseline Visite. Die Untersuchungen werden von einem mykologischen Labor nach gängiger Praxis durchgeführt,
    6. Gebärfähige Frauen mit einem negativen Urin Schwangerschaftstest zum Screening- und Baseline-Zeitpunkt müssen eine effektive Verhütungsmethode während der Studie benutzen: orale/systemische (Spritzen, Pflaster, etc. Verhütung muss 3 Monate vor Studienstart stabil gewesen sein), beidseitige Abbindung der Eileiter, hormonelle Spirale (mindestens 1 Monat vor dem Screening eingesetzt), strikte Abstinenz, oder einen vasektomierten Partner,
    7. Nicht-gebärfähige Frauen definiert als postmenopausal (seit mehr als einem Jahr keine Menstruationsblutung), Hysterektomie oder bilateraler Ovarektomie,
    8. Der Studienpatient hat die Patienteninformation an der Screening Visite verstanden, unterschrieben und eine Kopie davon ausgehändigt bekommen, bevor irgendwelche Studienuntersuchungen durchgeführt werden,
    9. Der Studienpatient ist gewillt und in der Lage den Anforderungen des Protokolls Folge zu leisten (einschließlich des Verzichts auf Benutzung anderer kosmetischer Nagelprodukte während der Studie auf den betroffenen Zehennägeln).
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA
    Any subject who meets one or more of the following criteria will not be included in the study.
    1. The subject with a surgical, medical condition or clinically important abnormal physical findings which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy),
    2. Post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject’s compliance of the investigational products, or mask the effects of treatment (cure),
    3. Known immunodeficiency, radiation therapy, immune suppressive drugs,
    4. Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study,
    5. Subjects needing to use any procedure or product (i.e. topical nail treatment, care or cosmetic lacquer) other than the investigational products on the toenails or surrounding skin during the study,
    6. Any other treatments which at the investigator’s judgment are liable to interfere or interact with the safety of study evaluation,
    7. Subjects with known sensitivity to any of the study preparations (see Summary of Products Characteristics - SmPC),
    8. Subjects participating in a clinical research study within the last 30 days prior to enrollment,
    9. Subjects under guardianship, hospitalized subjects in a public or private institution for a reason other than the research, and subjects deprived of his/her freedom.
    AUSSCHLUSSKRITERIEN
    Alle Studienpatienten, die eine oder mehrere der nachfolgenden Kriterien erfüllen, dürfen nicht in die Studie eingeschlossen werden.
    1. Studienpatienten mit chirurgischen, medizinischen oder klinisch wichtigen abnormen körperlichen Befunden, die nach Einschätzung des Prüfarztes eine Interpretation der Studienziele beeinträchtigen könnten. (z.B. fehlende Autonomie),
    2. Post-traumatischer Nagel, Lichen planus, Ekzem, Psoriasis oder andere Abnormalitäten der Nageleinheit, die die Einhaltung bezüglich der Studienmedikamente durch den Studienpatienten beeinträchtigen/beeinflussen, oder den Behandlungseffekt (Heilung) verdecken,
    3. Bekannte Immunschwäche, Strahlentherapie, Immunsuppressive Medikamente,
    4. Schwangerschaft, stillende Frauen oder Frauen, die planen während der Studie schwanger zu werden,
    5. Studienpatienten, die eine andere Behandlung oder ein anderes Produkt als die Studienmedikamente (z.B. für die oberflächliche Nagelbehandlung, Pflege oder kosmetischer Lack) für die Zehennägel oder der den Zehennagel umgebende Haut während der Studienteilnahme benötigen,
    6. Sonstige Behandlungen, die im Ermessen des Prüfarztes die Sicherheit der Studienauswertung beeinträchtigen oder diese beeinflussen könnten.
    7. Studienpatienten mit bekannter Überempfindlichkeit gegenüber den Studienmedikamenten (siehe Zusammenfassung der Packungsbeilage),
    8. Studienpatienten, die in den letzten 30 Tagen vor Studieneinschluss an einer klinischen Studie teilgenommen haben,
    9. Studienpatienten unter Vormundschaft, aus anderen Gründen in öffentlichen oder privaten Einrichtungen hospitalisierte Studienpatienten als für diese Studie, und Studienpatienten mit Freiheitsentzug.
    E.5 End points
    E.5.1Primary end point(s)
    Based on previous results, the clinical hypothesis is that subject’s adherence with the recommended regimen depends not only on the efficacy and safety of treatments but also on the ease of use of the treatments and application procedures
    Basierend auf vorherigen Ergebnissen, ist die primäre Hypothese, dass die Therapietreue der Studienpatienten bei der empfohlenen Anwendung nicht nur von der Wirksamkeit und Sicherheit der Behandlung abhängt, sondern auch von der Benutzerfreundlichkeit und Auftragungsweise.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to week 12 visit (end of study) or early termination
    bis zur Visite an Woche 12 (Ende der Studie) oder bis zum frühzeitigen Abbruch
    E.5.2Secondary end point(s)
    Effective duration of nail exposure after the application of either antifungal is longer than the recommended time to next application. Therefore, both the subjects’ adherence to the regimen recommended by the respective labels and the evaluation of effective nail exposure will be assessed using a subject Diary, direct questioning of subjects regarding their preference for one of the study products and via a questionnaire. This study has been designed to provide evidence in support of this hypothesis.
    Die tatsächliche Einwirkdauer auf den Nägeln nach der Anwendung von beiden Antimykotika ist länger als die empfohlene Zeit bis zur nächsten Anwendung. Deswegen wird sowohl die Therapietreue gemäß der jeweiligen Packungsbeilage als auch die tatsächliche Einwirkung auf den Nägeln mit Hilfe eines Patiententagebuchs, einer direkten Patientenbefragung und eines Patientenfragebogens bezüglich der Bevorzugung eines der Studienmedikamente bewertet. Diese Studie wurde erstellt, um diese Hypothese zu belegen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to week 12 visit (end of study) or early termination
    bis zur Visite an Woche 12 (Ende der Studie) oder bis zum frühzeitigen Abbruch
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    adherence and satisfaction
    Patiententreue und Zufriedenheit
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Intra-individuell
    Intra-individual
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ciclopoli® Nagellack
    Ciclopoli® Nail Lacquer
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years
    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 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    At the end of the study subjects may be provided with the study treatment (Loceryl® Nail Lacquer) at their request to complete the treatment of their toenail onychomycosis.
    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 Decision2015-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-25
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