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    Summary
    EudraCT Number:2012-003416-31
    Sponsor's Protocol Code Number:FAEDV-2012-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003416-31
    A.3Full title of the trial
    Multicenter, randomized, open clinical trial comparing three sessions of methyl-aminolevulinate 16% (Metvix®) photodynamic therapy versus a group without photodynamic therapy to treat onychomycosis.
    ENSAYO CLÍNICO ABIERTO, ALEATORIZADO Y MULTICÉNTRICO COMPARANDO TRES SESIONES DE TERAPIA FOTODINÁMICA CON METIL-AMINOLEVULINATO 16% (METVIX®) FRENTE A UN GRUPO SIN TERAPIA FOTODINÁMICA EN EL TRATAMIENTO DE LA ONICOMICOSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, randomized, open clinical trial to establish the effectiveness of of methyl-aminolevulinate 16% (Metivix®) photodynamic therapy to treat fungal infections of the nails.
    Ensayo clínico abierto, aleatorizado y multicéntrico para averiguar si la terapia fotodinámica con metil-aminolevulinato 16% (Metvix ®) en el tratamiento de las infecciones fúngicas de las uñas.
    A.3.2Name or abbreviated title of the trial where available
    MAL-PDT for onychomycosis
    TFD con MAL para onicomicosis
    A.4.1Sponsor's protocol code numberFAEDV-2012-01
    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 SponsorFundación Academia Española de Dermatología y Venereología
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGalderma
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación de la Academia Española de Dermatología y Venereología
    B.5.2Functional name of contact pointUnidad de Investigación
    B.5.3 Address:
    B.5.3.1Street AddressFerraz 100, 1ºizda
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28008
    B.5.3.4CountrySpain
    B.5.4Telephone number34915446284
    B.5.5Fax number3491494145
    B.5.6E-mailinvestigacion@aedv.es
    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 Metvix
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namemethyl-aminolevulinate
    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 INNmethyl-aminolevulinate
    D.3.9.3Other descriptive namemethyl aminolevulinic acid
    D.3.9.4EV Substance CodeL01XD03
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    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 Yes
    D.3.11.13.1Other medicinal product typeurea 40% ointment
    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 placeboCream
    D.8.4Route of administration of the placeboLocal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    onychomycosis
    fungal infections of the nails
    E.1.1.1Medical condition in easily understood language
    fungal infections of the nails
    infecciones fúngicas de las uñas
    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
    TO DETERMINE THE EFFECTIVENESS OF METHYL AMINOLEVULINATE (MAL) 16% PHOTODINAMIC THERAPY (PDT) (3 sessiones using 37 J/cm2) TO TREAT ONYCHOMYCOSIS
    Determinar la eficacia de la TFD con MAL (3 sesiones con 37 J/cm2) en el tratamiento de la onicomicosis.
    E.2.2Secondary objectives of the trial
    1. To describe the safety of MAL-PDT in onychomycosis, including immediate side effects and in the following months.
    2. To describe the improvement in quality of life of patients after treatment with MAL-PDT
    3. To describe the influence of other factors in the effectiveness of MAL-PDT: age, gender, presence of diabetes mellitus or immunosuppression, toenail involvement, feet or hands, involvement of the first toenail, number of nails involved, the clinical type of onychomycosis, severty index and the causative organism.
    1. Describir la seguridad de TFD con MAL en la onicomicosis, incluyendo efectos secundarios inmediatos y en los meses posteriores.
    2. Describir la mejora en la calidad de vida del paciente tras el tratamiento con TFD-MAL
    3. Describir la influencia de otros factores en la eficacia de la TFD con MAL: la edad, el sexo, la presencia de diabetes mellitus o inmunosupresión, la afectación de uñas de pies y/o manos, la afectación de la primera uña de pie y el número de uñas afectadas, el tipo clínico de onicomicosis, su índice de gravedad y el microorganismo causal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet criteria 1 and any of those in group 2:
    1. Onychomycosis of the hands or feet, as demonstrated by the positivity of any of the following: direct examination, culture (with growth of dermatophytes, yeasts or fungi non-dermatophytes) or nail plate biopsy (PAS + structures, suggestive of fungi inside the nail plate).
    2. Patients in the acceptable use of placebo:
    a) previously treated without success.
    b) with liver disease, kidney failure, or other comorbidities that increase the risk of systemic antifungal treatments.
    c) allergy or intolerance to systemic antifungal therapy.
    d) patients who express reluctance to systemic treatment and / or prolonged topical and prefer to participate in the EC.
    Los pacientes deben cumplir el criterio 1 y alguno de los del grupo 2, para que se les pueda solicitar su participación:
    1. Que tengan onicomicosis en manos o pies, demostrada por la positividad de alguna de las siguientes pruebas (que se realizarán a todos los pacientes): examen directo, cultivo (con crecimiento de dermatofitos, levaduras u hongos no-dermatofitos) o biopsia de lámina ungueal (estructuras PAS+, sugestivas de hongos en el interior de la lámina ungueal).
    2. Pacientes en los que sea aceptable el empleo de placebo:
    a) tratado anteriormente sin éxito.
    b) con hepatopatía, insuficiencia renal, u otras comorbilidades que aumentan el riesgo de los tratamientos antifúngicos sistémicos.
    c) alergia o intolerancia a los tratamientos antifúngicos sistémicos.
    d) pacientes que manifiesten reticencia a un tratamiento sistémico y/o tópico prolongado y que prefieran participar en el EC.
    E.4Principal exclusion criteria
    1. Patients under 18 years.
    2. Inability or unwillingness of the natural or legal person / representative to give written informed consent.
    3. Pregnant or breastfeeding.
    4. Patients with diseases that may affect the nail, such as psoriasis or lichen planus.
    5. Patients diagnosed with tinea pedis simultaneously clinically apparent .
    6. Patients under current treatment with oral or topical antifungal drugs.
    7. Hypersensitivity to any component of methyl aminolevulinate (MAL).
    8. Porphyria (a contraindication to the use of MAL)
    9. Allergy to almond oil or peanut (MAL excipients involved in contact allergy)
    1. Pacientes menores de 18 años.
    2. Incapacidad o falta de voluntad de la persona física o jurídica/representante para dar el consentimiento informado por escrito.
    3. Mujeres embarazadas o que piensen que puedan estarlo, o durante la lactancia. Las mujeres en edad fértil deben utilizar un método anticonceptivo durante la fase de tratamiento del ensayo clínico (desde el inicio hasta un mes después de la última sesión de TFD) para poder entrar en el ensayo.
    4. Pacientes con enfermedades que puedan afectar a la uña, como la psoriasis o liquen plano.
    5. Pacientes diagnosticados simultáneamente con tinea pedis clínicamente manifiesta (en los que sin tratamiento sistémico parece muy poco probable la curación de la onicomicosis, y no es aceptable el placebo).
    6. Pacientes bajo tratamiento actual con fármacos antimicóticos orales o tópicos.
    7. Hipersensibilidad a cualquier componente del metil aminolevulinato (MAL).
    8. Porfiria (contraindica el empleo de MAL)
    9. Alergia a los aceites de almendra o de cacahuete (excipientes del MAL implicados en alergia de contacto)
    E.5 End points
    E.5.1Primary end point(s)
    Clinical improvement, measured in standardized photos the severity index of onychomycosis (OSI).
    Mejoría clínica medida con el indice de gravedad de onicomicosis (OSI) mediante fotografías estandarizadas
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months.
    3, 6 y 12 meses
    E.5.2Secondary end point(s)
    1. Percentage of patients with complete clinical cure (OSI 0) and initial OSI reduction by 75%.
    2. Quality of life related to onychomycosis measured by a specific questionnaire
    3. Microbiological cure measured by the results of culture or direct examination of the fungus that causes onychomycosis and the absence of fungal structures inside the nail plate as determined by histology with PAS.
    1. Porcentaje de pacientes con curación clínica completa (OSI 0) y reducción del OS inicial del 75%.
    2. Calidad de vida relacionada con la onicomicosis medida mediante un cuestionario de vida específico.
    3. Cura microbiológica medida mediante los resultados del cultivo o examen directo del hongo que causa la onicomicosis y la ausencia de estructuras fúngicas dentro de la uña determinado mediante estudio histológico con PAS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 12 months
    3,6, y 12 meses
    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) 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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo Yes
    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 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 concerned3
    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
    ultima visita del ultimo sujeto del estudio
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.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)
    If onychomycosis persists:standard care. Given the inclusion criteria, patients not cured could be offered topical therapy and symptomatic care.
    Si la onicomicosis persiste se realizará tratamiento standard. Dados los criterios de inclusión, a los pacientes no curados se les puede ofrecer tratamientos tópicos o cuidados sintomáticos.
    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 Decision2013-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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