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    Summary
    EudraCT Number:2013-005595-17
    Sponsor's Protocol Code Number:PMPed-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-005595-17
    A.3Full title of the trial
    Multicentre, open label study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosis
    Estudio multicéntrico y abierto para valorar la tolerabilidad de la solución para uñas P-3058 en pacientes pediátricos afectados de onicomicosis leve a moderada.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the tolerability of P-3058 nail solution in paediatric patients affected by mild-to-moderate onychomycosis
    Estudio para evaluar la tolerabilidad de la solución para uñas P-3058 en pacientes pediátricos afectados de onicomicosis leve a moderada.
    A.4.1Sponsor's protocol code numberPMPed-004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/144/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPolichem S.A.
    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 supportPolichem S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPolichem S.A.
    B.5.2Functional name of contact pointDirector, Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressVia Senago 42 D
    B.5.3.2Town/ cityLugano
    B.5.3.3Post code6912
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34934453933
    B.5.5Fax number+34935504161
    B.5.6E-mailmaurizio.caserini@polichem.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 nameterbinafine hydrochloride
    D.3.2Product code P-3058
    D.3.4Pharmaceutical form Medicated nail lacquer
    D.3.4.1Specific paediatric formulation No
    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.3.9.2Current sponsor codeP-3058
    D.3.9.4EV Substance CodeSUB04723MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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
    Onicomicosis
    E.1.1.1Medical condition in easily understood language
    Fungal infection of the nails
    Infecciones micóticas de la uña
    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
    To evaluate the tolerability and safety of topical treatment with P-3058 10% o.w. in pediatric patients with onychomycosis.
    Evaluar la tolerabilidad y seguridad de tratamiento tópico con P-3058 10% una vez por semana en pacientes pediátricos con onicomicosis.
    E.2.2Secondary objectives of the trial
    - Overall safety evaluation by recording all adverse event
    occurring during the study; - Acceptance of therapy by children/Parents or Guardians at the end of treatment; - Complete cure defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement of the target nail at all study visits; - Responder rate defined as negative KOH microscopy and
    negative culture for dermatophytes and ?10% residual
    involvement of the target nail at all study visits; - Conversion to negative KOH microscopy at all study visits; - Conversion to negative culture for dermatophytes at all study visits; - Conversion to negative mycology (combination of negative KOH microscopy and negative dermatophytes culture); - Rate of patients having diseased nail ?10% or 0% (Clinical
    Cure); - Decrease of the target nail area at all study visits; - Time to reach the efficacy outcome cure/responder rate.
    - Evaluación de seguridad general registrando los efectos adversos ocurridos durante el ensayo - Aceptación de terapia por los niños/padres o tutores al final del tratamiento - Cura completa definida como compuesta de resultado negativo de KOH al microscopio y cultivo negativo de dermatofitos y no residuos de afectación en la uña objetivo en todas las visitas de estudio - Índice de respuesta definido como negativo en KOH al microscopio y cultivo negativo para dermatofitos y ?10% de afectación en la uña diana en todas las visitas ? Conversión a negativo de KOH microscopio en todas las visitas - Pasar a cultivo negativo de dermatofitos en todas las visitas - Pasar a negativo en micología (combinación de KOH negativo al microscopio y cultivo negativo de dermatofitos) - Índice de pacientes con enfermedad de la uña en un ?10% o 0% (Cura Completa) - Disminución del área de la uña diana en todas las visitas - Tiempo para alcanzar la eficacia de un resultado de cura/índice de respuesta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written Informed Consent given by the patient and
    parents/Guardians and in any case before starting any study
    related procedures; 2. Patients of both genders, aged between 2 and 17 years at the time of the written informed consent with established clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis (DSO) without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis (WSO); 3. Patients with positive KOH examination from the target nail chosen at screening; 4. Patients with positive culture for dermatophyte from the target nail chosen at screening.
    1-Firma del Consentimiento informado por el paciente y los padres/tutores legales y en cualquier caso antes de realizar cualquier procedimiento del estudio; 2. Pacientes de ambos géneros, de edades entre 2 y 17 años en el momento de firmar el consentimiento informado y con diagnóstico clínico establecido de onicomicosis leve a moderada subungueal distal (OSD) sin hifas/dermatofitoma y sin implicación de lúnula u onicomicosis blanca superficial (OBS); 3. Pacientes con examen positivo de KOH de la uña diana escogida en la selección; 4. Pacientes con cultivo positivo para dermatofitos en la uña diana escogida en la selección.
    E.4Principal exclusion criteria
    1. Patients with history of allergic reactions to terbinafine and/or to
    any of the other ingredients of P-3058; 2. Patients with history of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant; 3. Patients with onychomycosis caused by yeasts or nondermatophytes mould; 4. Patients with severe plantar or moccasin tinea pedis (defined by blistering, pustules or inability to ambulate). Patients with mildto-moderate tinea pedis using a topical antifungal treatment will be included; 5. Congenital or acquired nail dystrophy (i.e. Darier?s disease); 6. Patients with nail psoriasis; 7. Patients with nail changes due to eczema, lichen planus or alopecia areata; 8. Patients with one-hand two-foot syndrome; 9. Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it; 10. Use of systemic antifungal drugs in the 6 months prior to screening visit; 11. Use of topical nail antifungal drugs in the four weeks prior to screening visit; 12. Habitual finger sucking during the night in children that have fingernail onychomycosis if it cannot be prevented by parents; 13. Female subjects physiologically capable of becoming pregnant are asked to refrain from any sexual intercourse during the whole study duration or to use acceptable methods of contraception
    agreed with the investigator; 14. Female subjects who are pregnant, nursing mothers, those planning a pregnancy during the course of the study or who
    become pregnant.
    1. Pacientes con antecedentes de reacciones alérgicas a terbinafina y/o alguno de los otros ingredientes de P-3058; 2. Pacientes con antecedentes de disfunción cardiovascular, renal, neurológica, hepática, inmunológica o endocrina si son clínicamente significativos; 3. Pacientes con onicomicosis causada por levaduras o mohos no dermatofitos; 4. Pacientes con tinea pedis plantar o en mocasin severa (definida por formación de ampollas, pústulas o incapacidad para deambular). Pacientes con tinea pedis leve a moderada que estén utilizando un tratamiento tópico antifúngico pueden ser incluidos; 5. Distrofia ungueal congénita o adquirida (ej. Enfermedad de Darier); 6. Pacientes con psoriasis ungueal; 7. Pacientes con cambios en las uñas debido a eccema, liquen plano o alopecia areata; 8. Pacientes con síndrome mano-pie; 9. Pacientes con trastorno de inmunodeficiencia o uso de terapia inmunosupresora en los tres meses previos a la visita de selección o necesidad de ella; 10. Uso de medicación antifúngica sistémica en los seis meses previos a la visita de selección; 11. Uso de medicación antifúngica tópica para la uña en las 4 semanas previas a la selección; 12. Niños con onicomicosis en las uñas de las manos con el hábito de chuparse el dedo durante la noche si no puede ser prevenido por los padres; 13. Se pide a las pacientes de sexo femenino fisiológicamente capaces de quedarse embarazadas se abstengan de tener relaciones sexuales durante la duración total del estudio o que usen métodos aceptables de contracepción acordados con el investigador; 14. Mujeres que estén embarazadas, madres lactantes, aquellas que planeen quedarse embarazadas durante el curso del estudio o aquellas que se queden embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Local tolerability at the application site (all treated nails) during the
    study period by means of the Severity Score for Skin Irritation.
    Tolerabilidad local en el sitio de aplicación (todas las uñas tratadas) durante el período de ensayo mediante la puntuación de gravedad para irritación cutánea.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the study.
    Durante el ensayo.
    E.5.2Secondary end point(s)
    - Overall safety evaluation by recording all adverse event
    occurring during the study; - Acceptance of therapy by children/Parents or Guardians at the end of treatment; - Complete cure defined as composite of negative KOH microscopy and negative culture for dermatophytes and no residual clinical involvement of the target nail at all study visits; - Responder rate defined as negative KOH microscopy and negative culture for dermatophytes and ?10% residual involvement of the target nail at all study visits; - Conversion to negative KOH microscopy at all study visits; - Conversion to negative culture for dermatophytes at all study visits; - Conversion to negative mycology (combination of negative KOH microscopy and negative dermatophytes culture); - Rate of patients having diseased nail ?10% or 0% (Clinical
    Cure); - Decrease of the target nail area at all study visits; - Time to reach the efficacy outcome cure/responder rate.
    - Evaluación global de la seguridad mediante el registro de todos los acontecimientos adversos que tengan lugar durante el estudio; - Aceptación del tratamiento por parte de los niños/padres o tutores al finalizar el tratamiento; - Curación total se define como la conjunción de un resultado negativo en el cultivo de dermatofitos unidos a la falta de afectación clínica residual de la uña diana en todas las visitas del estudio. El índice de respuesta definido como la conjunción de un resultado negativo de KOH bajo microscopio y un resultado negativo en el cultivo de dermatofitos unidos a un porcentaje de ?10% de afectación residual de la uña diana en todas las visitas del estudio; - Conversión a negativo en la prueba KOH bajo el microscopio en todas las visitas del estudio; - Conversión a negativo en el cultivo de dermatofitos en todas las visitas del estudio; - Conversión a resultado micológico negativo (combinación de resultado negativo en prueba KOH bajo microscopio y resultado negativo en el cultivo de dermatofitos); - Porcentaje de pacientes con una uña afectada ?10% o 0% (curación clínica); - Disminución del área afectada de la uña diana en todas las visitas del estudio; - Tiempo para alcanzar el resultado de eficacia de curación/porcentaje de pacientes que respondieron al tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - during the study; - at the end of treatment; - at all study visits; - at all study visits; - at all study visits; - at all study visits; - during the study; - during the study; - at all study visits; - during the study.
    -durante el ensayo; -al final del tratamiento; - en todas las visitas del ensayo; - en todas las visitas del ensayo; - en todas las visitas del ensayo; - en todas las visitas del ensayo; - durante el ensayo; - durante el ensayo; - en todas las visitas del ensayo; - durante el ensayo
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tolerabilidad
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The end of study is defined as the date of database locked.
    El fin del ensayo está definido como la fecha del cierre de la base de datos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 35
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 13
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    F.1.2Adults (18-64 years) No
    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 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
    paediatric patients aged between 2 and 17 years
    Pacientes pediátricos de edades comprendidas entre 2 y 17 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    Standard therapy
    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 Decision2015-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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