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    Summary
    EudraCT Number:2010-018793-21
    Sponsor's Protocol Code Number:CL-067-III-01
    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:2010-03-26
    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 number2010-018793-21
    A.3Full title of the trial
    A Randomized, Double-blind, Vehicle- and Placebo-Controlled, Multicenter Trial in Patients with Mild to Moderate Distal Subungual Toenail Onychomycosis to Investigate the Efficacy, Tolerability, and Safety of Twice Daily Application of TDT 067 for 48 Weeks
    A.4.1Sponsor's protocol code numberCL-067-III-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01145807
    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 SponsorCeltic Pharma Development Services Bermuda Limited
    B.1.3.4CountryBermuda
    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 nameTDT 067 (1.5% terbinafine in Transfersome®)
    D.3.2Product code TDT 067
    D.3.4Pharmaceutical form Cutaneous suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNterbinafine hydrochloride
    D.3.9.1CAS number 78628-80-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 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 nameTransfersome® vehicle
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Cutaneous suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    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 placeboCutaneous suspension
    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
    Clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology (culture and potassium hydroxide [KOH] visualization) (tinea unguium).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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
    To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus
    non-Transfersome® placebo.
    If the comparison between TDT 067 and non-Transfersome® placebo is statistically significant in favor of TDT 067 (at a 2-sided P<0.05), the following secondary objective will become an additional
    primary efficacy objective:
    To compare complete cure rates for onychomycosis at Week 52 for TDT 067 versus
    Transfersome® vehicle.
    E.2.2Secondary objectives of the trial
    To compare complete cure rates for onychomycosis at Weeks 48 and 60 for TDT 067 versus non-Transfersome® placebo and Transfersome® vehicle
    To compare effective treatment rates at Weeks 48 52, and 60 for TDT 067 versus non-Transfersome® placebo and Transfersome® vehicle
    To compare mycological cure rates at Weeks 48, 52, and 60 for TDT 067 versus
    non-Transfersome® placebo and Transfersome® vehicle
    To compare complete cure rates at Weeks 48, 52, and 60, effective treatment rates at Weeks 48, 52, and 60, and mycological cure rates at Weeks 48, 52, and 60 for Transfersome® vehicle versus non-Transfersome® placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Patients must be between 18 and 75 years of age inclusive, of any race, and of either sex.
    Female patients must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing a highly effective method of birth control and must agree to continue to use this method of birth control while participating in the study. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. <1% per year) when used consistently and correctly. Acceptable methods of birth control are oral, injectable, or implanted hormonal contraceptive, intrauterine device, and diaphragm with spermicide.
    2. Patients must have at least 1 great toenail (target toenail) with clinically diagnosed distal subungual onychomycosis involving between 25% and 65%, inclusive, of the nail and confirmed by KOH visualization and fungal culture positive for dermatophytes. (Patients with culture positive for dermatophytes alone or dermatophytes and non-dermatophytes are eligible to participate.) If both great toenails meet inclusion criteria, the one with the greater involvement will be designated the target nail.
    3. Patients must be able to understand the requirements of the study, abide by the restrictions, and return for all of the required examinations.
    4. Patients must be willing to sign a statement of informed consent.
    5. Patients must have a target great toenail with the capability to grow as determined by history of nail cutting.
    6. Patients must be willing to refrain from using any nail polish products and other nail cosmetic products on any of the toenails and must be willing to refrain from professional pedicures for the duration of this study (from screening visit until follow-up Week 60).
    E.4Principal exclusion criteria
    Patients with any of the following exclusion criteria will not be eligible for enrollment into the study:
    1. Patients who have been treated with an investigational drug within 1 month prior to Screening.
    2. Patients who are pregnant or planning to become pregnant or who are lactating.
    3. Patients with hypersensitivity to terbinafine or to any other ingredients of the formulation.
    4. Patients who are unable to spray their toenails and the surrounding tissues on the affected foot without assistance.
    5. Patients with symptomatic tinea pedis requiring treatment.
    6. Patients using oral terbinafine within 6 months prior to Screening; patients who have received other oral antifungals within 3 months.
    7. Patients using topical antifungal treatments for onychomycosis within 1 month prior to Screening; patients using topical antifungal treatments for the feet within 1 month prior to Screening.
    8. Patients with any nail dystrophy that will interfere with the assessment of a clear nail. Patients who have toenail abnormalities or dystrophies that could prevent the restoration of a normal appearing nail in spite of a mycological cure, including patients with psoriasis, lichen planus, malignancy or pigmentation disorders involving the nail unit, chemical damage, or onychodystrophy due to trauma or other structural deformities.
    9. Patients with superficial white or proximal subungual onychomycosis.
    10. Patients with a toenail infection involving a non-dermatophyte alone.
    11. Patients with involvement of the matrix (lunula) or the proximal 2 mm of nail as measured from the proximal nail fold.
    12. Patients who have a nail plate with thickness greater than 2 mm or total thickness of the nail plus subungual debris measuring greater than 3 mm.
    13. Patients with yellow streaks or dermatophytoma of the target toenail.
    14. Patients with a history of peripheral arterial disease or diabetes mellitus.
    15. Patients with any condition that in the opinion of the Investigator renders the patient unsuitable for participation in this study.
    16. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal without clinical reason, unless, in the opinion of the Investigator, participation in this study would not place the patient at undue risk.
    17. Patients with a reported history of immunodeficiency and patients with a reported history of cutaneous or systemic lupus erythematosus.
    E.5 End points
    E.5.1Primary end point(s)
    Complete cure at Week 52
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    TDT 067 Vehicle
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days18
    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 Information not present in EudraCT
    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 state92
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 738
    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)
    After a patient has completed/ terminated the study, any of the available treatments for distal subungual toenail onychomycosis will be provided at the discretion of the investigator as per standard of care.
    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 Decision2010-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-13
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