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    Summary
    EudraCT Number:2018-000294-78
    Sponsor's Protocol Code Number:CTP001H
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-07-04
    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 ConcernedIreland - HPRA
    A.2EudraCT number2018-000294-78
    A.3Full title of the trial
    A Randomized, Single-Blinded, Comparative Study of Mycosinate and Curanail in the Treatment of Fungal Nail Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Single-Blinded, Comparative Study of Mycosinate and Curanail in the Treatment of Fungal Nail Infection
    A.4.1Sponsor's protocol code numberCTP001H
    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 SponsorNektr Technologies
    B.1.3.4CountryIreland
    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 supportEnterpise Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiamond BioPharm Limited
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressSuite 2, Ground Floor, Field House, Station Approach
    B.5.3.2Town/ cityHarlow Essex
    B.5.3.3Post codeCM20 2FB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203 9119410
    B.5.5Fax number004401279 418964
    B.5.6E-mailamalcolm@diamondpharmaservices.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 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 nameMycosinate
    D.3.2Product code A3IS
    D.3.4Pharmaceutical form Gel
    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 INNGlucose
    D.3.9.1CAS number 77938-63-7
    D.3.9.2Current sponsor codeCTP001B
    D.3.9.3Other descriptive nameGLUCOSE
    D.3.9.4EV Substance CodeSUB13981MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucose Oxidase
    D.3.9.1CAS number 9001-37-0
    D.3.9.2Current sponsor codeCTP001B
    D.3.9.3Other descriptive nameGLUCOSE OXIDASE
    D.3.9.4EV Substance CodeSUB13984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.50
    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) Yes
    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 Curanail
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma (UK) Limited,
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCuranail
    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 INNAMOROLFINE HYDROCHLORIDE
    D.3.9.1CAS number 78613-35-1
    D.3.9.2Current sponsor codeCTP001B
    D.3.9.3Other descriptive nameAMOROLFINE
    D.3.9.4EV Substance CodeSUB05476MIG
    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.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
    Onychomycosis
    E.1.1.1Medical condition in easily understood language
    Fungal Nail Infection
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. % Reduction in the Size of Infection
    Photos taken during the trial will be analyzed by the statistician who will measure both the entire size of the nail and the size of the infected portion of the nail. Using this data, the statistician will be able to calculate the % reduction in the size of the infection as the trial progresses.

    2. Viability of the Infection at Time ‘T’ (Mycological Cure Rate)
    Confirmation testing will be carried out in a 3rd party contract laboratory and will be cultured to determine the viability of the infection at the various time points in the study.
    E.2.2Secondary objectives of the trial
    1. Relapse Rates
    The viability testing carried out from the month 6 follow up visit will form the relapse rate results. If the infection is viable at 9 month and was not viable at month 6 then the patient has relapsed.

    2. Adverse Reactions
    Any adverse reactions will be recorded and serious adverse reactions will be reported directly to the HPRA via the sponsor’s pharmacovigilance provider, Diamond Pharma Services.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Confirmed presence of hyphae through microscopy of nail sample taken from patient. (Further details of nail sampling given in section 2.7.5)
    • In good overall health (Subject to Health Assessment conducted by the responsible Physician).
    • Male and Female aged between 18-65 inclusive.
    • The fungal infection is seen across 20-75% of the nail with no involvement of the lunula. (Details of nail sizing protocol given in section 2.8.1)
    • Subject is willing and available to return for study follow ups.
    • Subject is willing to discontinue use of cosmetic nail products for the duration of the study.
    • Subjects must agree to refrain from using other nail fungus treatments for the duration of the study
    • Physical examination without significant deviations.
    E.4Principal exclusion criteria
    • Diabetics.
    • Severe cases of onychomycosis (e.g. complete coverage of nail).
    • Chronic conditions such as immune deficiency, chronic vascular disease or psoriasis.
    • Currently involved in another clinical trial.
    • Patients who are pregnant or breastfeeding.
    • Severe secondary dermal infections
    • Patients suffering from proximal subungual onychomycosis
    • Any medical condition which may place the patient at risk of infection or delayed wound healing
    • Patients using immunosuppressant drugs
    • Other conditions known to cause an abnormal nail appearance
    • Known allergy to any of the ingredients in the study treatments
    • Patient has been using any antifungal therapy for the removal of the infection, either systemic or topical, in the past 6 months.
    • Patients who have damaged or broken periungual skin.
    E.5 End points
    E.5.1Primary end point(s)
    1) Viability of the infection
    2) % Reduction in the Size of Infection (Visual improvement)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both primary endpoints assessed at T=0 weeks, 3 weeks, 6 weeks, 12 weeks, 6 months and 9 months
    E.5.2Secondary end point(s)
    1) Relapse rates
    2) Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Relapse rates - measured at 6 month and 9 month visits
    2) Adverse events - recorded throughout duration of study
    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) Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 60
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Not different from the expected normal treatment of that condition
    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 Decision2019-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-12
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