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    Summary
    EudraCT Number:2015-001503-31
    Sponsor's Protocol Code Number:RD.03.SPR.105078
    National Competent Authority:Iceland - IMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-30
    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 ConcernedIceland - IMCA
    A.2EudraCT number2015-001503-31
    A.3Full title of the trial
    Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Canesten® Fungal Nail Treatment Set
    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 Canesten® Fungal Nail Treatment Set
    A.3.2Name or abbreviated title of the trial where available
    OPEN
    A.4.1Sponsor's protocol code numberRD.03.SPR.105078
    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 pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address2400 Route des Colles - Les Templiers
    B.5.3.2Town/ cityBiot
    B.5.3.3Post code06410
    B.5.3.4CountryFrance
    B.5.4Telephone number+33493957051
    B.5.5Fax number+33493957164
    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 Nordic AB
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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
    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 Canesten® Bifonazole cream
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Australia LTD
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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 Cream
    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 INNBIFONAZOLE
    D.3.9.1CAS number 60628-96-8
    D.3.9.3Other descriptive nameBIFONAZOLE
    D.3.9.4EV Substance CodeSUB05831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 3
    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 Canesten® Urea ointment
    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 nameUrea
    D.3.4Pharmaceutical form Ointment
    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 INNUREA
    D.3.9.1CAS number 57-13-6
    D.3.9.3Other descriptive nameUREA
    D.3.9.4EV Substance CodeSUB15662MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeOrganic compound
    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
    Mycological confirmed toenail Distal and Lateral Subungual Onychomycosis
    E.1.1.1Medical condition in easily understood language
    Toenail Onychomycosis
    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 18.1
    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 is to compare subject-reported ease of use, adherence and satisfaction for two modes of treatment of Distal and Lateral Subungual Onychomycosis (DLSO) with Loceryl® Nail Lacquer (Amorolfine) and Canesten® Fungal Nail Treatment Set (Urea 40% ointment and Bifonazole cream) in toenails
    E.2.2Secondary objectives of the trial
    Subject safety satisfaction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In general, the investigator will ensure to enroll subjects with homogenous disease characteristics regarding affected toenails within the limits defined below:
    1. Male or female subjects aged 18 years or older,
    2. Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
    3. Subjects with less than 50% of the toenail surface area from the Distal edge 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) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline. The exams will be performed by the Mycological Laboratory as usual in routine practice (see attachment 1),
    6. Females of childbearing potential with a negative Urine Pregnancy Test (UPT) at Screening and Baseline visits must use a highly 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, 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 visit 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 or other nail products on the affected toenails during the study).
    Rationale:
    1-4: In order to select a suitable population for the clinical trial,
    5: To include only subjects with confirmed onychomycosis,
    6-7: Due to limited amount of data on human pregnancy,
    8: Only subjects who provided written consent are allowed to participate in this clinical trial,
    9: In order to ensure compliance to the clinical trial.
    E.4Principal exclusion criteria
    Any subject who meets one or more of the following criteria will not be included in the study:
    1. Subjects with matrix involvement on the great toenails,
    2. Subjects with a surgical, medical condition or clinically important abnormal physical findings which, in the judgment of the investigator, might interfere with the interpretation of the objectives of the study (i.e. lack of autonomy),
    3. Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject’s compliance with the investigational products or mask the effects of treatment (cure),
    4. Known immunodeficiency, radiation therapy, immune suppressive drugs,
    5. Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study,
    6. 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,
    7. Any other treatments, which at the investigator’s judgment are liable to interfere or interact with the safety of study evaluation,
    8. Subjects with known sensitivity to any of the study preparations (see Summary of Products Characteristics - SmPC),
    9. Subjects participating in a clinical research study within the last 30 days prior to enrollment,
    10. 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.
    Rationale:
    1: As per product labeling and to optimize the treatment and the provided devices,
    2-4: In order to select subjects solely with onychomycosis and to avoid any interference or confounding factors with the evaluation, study outcomes and interpretation of results,
    5: Due to limited amount of data regarding human pregnancy or lack of data on amorolfine excretion in human milk,
    6-8: To avoid potential safety concerns with use of the study drug,
    9-10: To comply with ICH-GCP.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to week 13 visit (end of study) or early termination
    E.5.2Secondary end point(s)
    Both the subjects’ adherence to the regimen recommended by the respective labels and the compliance with treatment application procedures 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to week 13 visit (end of study) or early termination
    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
    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 Yes
    E.8.1.3Single blind No
    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-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
    Loceryl® Nail Lacquer + Canesten® Fungal Nail Treatment Set (Urea 40% / Bifonazole 1%)
    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 Decision2015-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-14
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