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    Summary
    EudraCT Number:2008-002707-10
    Sponsor's Protocol Code Number:PM0731
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-05
    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 ConcernedLatvia - SAM
    A.2EudraCT number2008-002707-10
    A.3Full title of the trial
    MULTICENTRE, RANDOMIZED, DOUBLE BLIND WITHIN FREQUENCY OF ADMINISTRATION, PLACEBO CONTROLLED, DOSE-FINDING, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF 3 DOSES OF P-3058 NAIL LACQUER (5% o.d., 10% o.d., AND 10% o.w.) GIVEN FOR 52 WEEKS IN PATIENTS WITH ONYCHOMYCOSIS
    A.4.1Sponsor's protocol code numberPM0731
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPolichem SA
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameP-3058 5%
    D.3.2Product code P-3058 5%
    D.3.4Pharmaceutical form Medicated nail lacquer
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTerbinafine
    D.3.9.1CAS number 78628805
    D.3.9.2Current sponsor codeP-3058
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameP-3058 10%
    D.3.2Product code P-3058 10%
    D.3.4Pharmaceutical form Medicated nail lacquer
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTerbinafine
    D.3.9.1CAS number 78628805
    D.3.9.2Current sponsor codeP-3058
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboMedicated nail lacquer
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate distal subungual Onychomycosis due to Dermatophytes.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.1
    E.1.2Level LLT
    E.1.2Classification code 10030338
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of different doses of P-3058 compared to placebo in the treatment of onychomycosis after 52-week treatment.
    E.2.2Secondary objectives of the trial
    • To evaluate the shape and the location of the dose response-curve of the efficacy outcome (responders rate).
    • To determine the maximal dose beyond which additional benefit would be unlikely to occur.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    “Pharmacokinetics evaluation in blood and nail samples of 3 doses of P-3058 nail lacquer (5% o.d., 10% o.d., and 10% o.w.) given for 52 weeks in patients with onychomycosis”.

    Final version: 2008/09/30

    Objective: to evaluate nail concentrations and systemic exposure to the test products after multiple applications in a long-term study.
    E.3Principal inclusion criteria
    • Written informed consent before starting any study related procedures
    • Patients aged ≥12 up to 80 years old
    • Males or females, outpatients
    • Patients with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis (i.e. involving ≥ 25% to ≤ 60% of the distal bed-adherent nail plate without involvement of the lunula) caused by dermatophytes, affecting at least one big toenail
    • Patients with positive KOH examination from the target big toenail obtained at screening
    • Patients with positive culture for only dermatophyte/s in screening nail sample
    E.4Principal exclusion criteria
    • Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant.
    A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study.
    • Patients with a recent history (< 1 year) of myocardial infarction and/or (< 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
    • Patients with liver function impairment AST, ALT more than twice above the upper limit of reference range
    • Patients with kidney function impairment serum creatinine more than twice above the upper limit of reference range
    • History of cancer within the past 5 years, excluding treated basal cell carcinoma
    • Chemotherapy, immunosuppressive therapy in the 12 weeks prior to screening visit
    • Systemic glucocorticosteroids, antimetabolites and immunostimulants therapy in the 4 weeks prior to screening visit
    •Alcohol or substance abuse
    • HIV infection or any other immunodeficiency
    • Patients unable to understand the procedures and purposes of the study
    • Patients with history of allergic reactions to terbinafine or its excipients
    • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of study medication
    • Patients using nail polish or other nail cosmetic product on the concerned nails from at least 24 hours prior to study drug administration until the end of the study
    • Patients with target nail hyperkeratosis exceeding 4 mm in thickness
    • Patients with proximal subungual involvement (marker of immunosuppressed patient)
    • Disease involving <25% or >60% of distal bed-adherent nail plate
    • Patients with mucocutaneous candidiasis
    • Patients with white superficial onychomycosis
    • Patients with onychomycosis caused by yeasts or non-dermatophytes mould
    • Patients with "Yellow spikes" on the target nail (extension of fungal infection from distal to proximal part of nail)
    • Patients with lunula involvement (marker of immunosuppressed patient)
    • Patients with negative KOH examination at screening
    • Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate)
    • Patients with nail abnormalities due to conditions like psoriasis or lichen planus
    • Patients with uncontrolled diabetes
    • Patients with recurrent erysipela at screening visit [If erysipela infection occurs during the study, the patient is allowed to continue the study and to be treated with antibiotic therapy (penicillin)]
    • Use of systemic antifungal drugs in the 6 months prior to screening visit
    • Use of topical products containing terbinafine in the 3 months prior to screening visit
    •Use of topical antifungal drugs (other than terbinafine) in the four weeks prior to screening visit
    •Breast-feeding patients
    •Positive urine pregnancy test at screening
    •Women of child-bearing potential or in menopause for less than 1 year not using a reliable method of contraception.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point is the responders rate as evaluated by the central, blinded Assessor at week 52 (end of treatment) This is defined as patients with conversion to negative of culture and of microscopic KOH examination and with decrease of affected nail area to ≤10% of total.

    Secondary efficacy end-points:
    •Cure rate defined as complete replacement of the affected nail by new healthy nail, as evaluated by a central, blinded Assessor, accompanied by conversion to negative of culture and of microscopic KOH examination at week 16, 28, 40, 52 (end of treatment), 64 and 76
    •Conversion to negative of culture at week 4, 16, 28, 40, 52, 64 and 76
    •Conversion to negative of microscopic finding on KOH preparation at week 4, 16, 28, 40, 52, 64 and 76
    •Determination of growth rate of healthy nail at week 16, 28, 40, 52, 64 and 76 by the central, blinded Assessor
    •Responders as evaluated by the central, blinded Assessor at week 16, 28, 40, 64 and 76
    •Responders as evaluated by the local Investigator at week 16, 28, 40, 52, 64 and 76
    •Decrease of the affected nail area to ≤ 10% of the total at week 4,16, 28, 40, 52, 64 and 76
    •Time to reach the efficacy outcome responder
    •Time to reach the efficacy outcome cure
    •Rate of relapse at week 76 (at least one among the following: affected target nail area >10%, culture positive, KOH positive), in patients “cured” at week 52
    •Acceptance of therapy by patient
    •Overall safety evaluation
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 336
    F.4.2.2In the whole clinical trial 336
    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)
    The study medication will not be available to patients after study termination or prematurely withdrawn from the study. Follow up treatment within the scope of the study is not planned as there exist a number of alternative therapies for the treatment of 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 Decision2009-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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