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    Summary
    EudraCT Number:2015-002663-42
    Sponsor's Protocol Code Number:TFDTRASP
    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:2015-09-11
    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 number2015-002663-42
    A.3Full title of the trial
    RANDOMISED PILOT STUDY TO ASSESS THE CLINICAL EFFICACY OF DAYLIGHT PHOTODYNAMIC THERAPY WITH METHYL AMINOLEVULINATE CREAM (METVIX?), (MAL-PDT), IN THE PREVENTION OF ACTINIC KERATOSIS AND NON MELANOMA SKIN CANCER IN TRANSPLANT PATIENTS
    ESTUDIO PILOTO ALEATORIZADO PARA VALORAR LA EFICACIA CLÍNICA DE LA TERAPIA FOTODINÁMICA CON CREMA DE METIL-AMINOLEVULINATO (METVIX?), (MAL-TFD) CON LUZ DE DÍA EN LA PREVENCIÓN DE QUERATOSIS ACTÍNICAS Y CÁNCER CUTÁNEO NO MELANOMA EN PACIENTES TRASPLANTADOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO ASSESS IF THE DAYLIGHT PHOTODYNAMIC THERAPY WITH METHYL AMINOLEVULINATE CREAM (METVIX?), (MAL-PDT) IS USEFUL TO PREVENT PRECANCEROUS CUTANEOUS LESIONS AND NON MELANOMA SKIN CANCER IN TRANSPLANT PATIENTS
    ESTUDIO PARA VALORAR SI LA TERAPIA FOTODINÁMICA CON CREMA DE METIL- AMINOLEVULINATO (METVIX?), (MAL-TFD) CON LUZ DE DÍA ES ÚTIL PARA PREVENIR LA APARICIÓN DE LESIONES CUTÁNEAS PRECANCEROSAS Y CÁNCER CUTÁNEO NO MELANOMA EN PACIENTES TRASPLANTADOS
    A.4.1Sponsor's protocol code numberTFDTRASP
    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 SponsorClínica Universidad de Navarra/Universidad de Navarra
    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.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClínica Universidad de Navarra
    B.5.2Functional name of contact pointUCEC
    B.5.3 Address:
    B.5.3.1Street AddressAvd. Pio XII 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number349482554002725
    B.5.5Fax number34948296667
    B.5.6E-mailucicec@unav.es
    D. IMP Identification
    D.IMP: 1
    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 Metvix
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Ltd
    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 nameMetvix (metil-aminolevulinato)
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-aminolevulinic acid
    D.3.9.1CAS number 33320-16-0
    D.3.9.2Current sponsor codeMetvix
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE
    D.3.9.4EV Substance CodeSUB22645
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    Actinic Keratosis (AK) are histologically characterized by the proliferation of keratinocytes with atypical cytology in the epidermis. One of the main risk factors for its occurrence is immunosuppression.
    Las Queratosis Actínica (QA) se caracterizan histológicamente por la proliferación de queratinocitos con citología atípica en la epidermis. Uno de los principales factores de riesgo en su aparición es la inmunosupresión.
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis are premalignant lesions that occur as red, scaly patches on the face and scalp (in areas not covered by hair).
    Las queratosis actínicas son lesiones premalignas que se manifiestan como manchas rojas con descamación en cara y también en el cuero cabelludo (en zonas no cubiertas por pelo).
    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
    Assess if there are less appearance of AK in the side treated with repeated treatments of daylight photodynamic therapy compared with the side treated with cryotherapy, in transplant patients, at 21 months from treatment initiation.
    Evaluar si en el lado tratado periódicamente con TFD con luz de dia aparecen menos queratomas actínicos que en el lado tratado periódicamente con crioterapia, en pacientes trasplantados, a los 21 meses de inicio del tratamiento.
    E.2.2Secondary objectives of the trial
    1. Assess the differences in the number of new AK and NMSC between the two treatments at 3, 9, 15 and 21 months.
    2. Assess the differences in the number of persistent AK and NMSC between the two treatments at 3, 9, 15 and 21 months.
    3. Assess the differences in the time to onset of the first AK and NMSC between the two treatments.
    4. To establish the safety of the procedure.
    5. Assess the differences in cosmetic outcome between treatments at different measurement times.
    6. Assess the differences in patient preference between the two treatments at different measurement times.
    7. Assess the differences in patient satisfaction between the two treatments at different measurement times.
    8. Assess the differences in the quality of life of patients between treatments, before starting the study and at the end study (last visit).
    1. Comprobar si hay diferencias en el número de nuevos QA y CCNM entre los dos tratamientos a los 3, 9, 15 y 21 meses.
    2. Comprobar si hay diferencias en el número de persistentes QA y CCNM entre los dos tratamientos a los 3, 9, 15 y 21 meses
    3. Comprobar si hay diferencias en el tiempo de aparición de la primera QA y CCNM entre los dos tratamientos.
    4. Establecer la seguridad del procedimiento.
    5. Comprobar si hay diferencias en el resultado cosmético entre ambos tratamientos en los diferentes tiempos de medida.
    6. Comprobar si hay diferencias en la preferencia del paciente entre ambos tratamientos en los diferentes tiempos de medida.
    7. Comprobar si hay diferencias en la satisfacción del paciente entre ambos tratamientos en los diferentes tiempos de medida.
    8. Comprobar si hay diferencias en la calidad de vida del paciente entre ambos tratamientos antes de iniciar el estudio y al finalizar el estudio (última visita).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients should meet all of the following inclusion criteria:
    1. Transplanted liver, heart or kidney patients with diagnosis of photo-actinic damage.
    2. Legal age patients: greater than or equal to 18 years old.
    3. The patient should voluntarily sign the informed consent before performing any test trial which is not part of routine care of patients.
    4. The patient should, according to the investigator's opinion, be able to comply with all requirements of the clinical trial.
    5. Minimum 5 years of transplant.
    6. Presence of at least 5 actinic keratosis in symmetrical areas to be treated in each hemiface and/or hemi-scalp, if appropriate.
    7. For women of childbearing age, negative pregnancy test at selection time.
    It is considered that a woman has not reproductive capacity if she´s postmenopausal (a minimum of two years without menstruation) or have undergone surgical sterilization (at least one month prior to the study). It is considered acceptable to include women using a safe means of contraception (abstinence is considered an acceptable method) throughout the study period and at least another month.

    Pregnant women will be excluded from the study. Women of childbearing age will be performed a pregnancy test. Most transplanted women with actinic damage are in postmenopausal age so it is probably not include any woman of childbearing age.
    Todos los pacientes deben cumplir todos los siguientes criterios de inclusión:
    1. Pacientes trasplantados hepáticos, cardiacos o renales diagnosticados de daño epitelial fotoactínico.
    2. El paciente deberá ser mayor de 18 años de edad.
    3. El paciente ha otorgado su consentimiento para participar en el estudio.
    4. El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
    5. Que hayan pasado mínimo 5 años desde el trasplante.
    6. Presencia, al menos, de 5 lesiones queratósicas en cada una de las hemicaras y hemiáreas del cuero cabelludo, si procede, simétricas a tratar.
    7. En caso de mujer en edad fértil, test de embarazo negativo en la fecha de selección.

    Se considera que una mujer no tiene capacidad reproductora si es posmenopáusica (un mínimo de 2 años sin menstruación) o se ha sometido a esterilización quirúrgica (como mínimo, un mes antes del estudio). Se considerará aceptable incluir mujeres que utilicen un medio seguro de anticoncepción (la abstinencia se considera un método aceptable) durante todo el periodo del estudio y al menos un mes más.
    Las mujeres embarazadas se excluirán del estudio. A las mujeres en edad fertil se les realizará un test de embarazo. La mayoría de las mujeres trasplantadas con daño actínico están en edad posmenopáusica por lo que es probable que no se incluya ninguna mujer en edad fertil.
    E.4Principal exclusion criteria
    Patients presenting any of the following exclusion criteria will not be able to be included into the clinical trial:
    1. Hypersensitivity to the active substances of the drug or any of its excipients (including allergy to peanuts or soybeans).
    2. Patients with porphyria.
    3. Pregnant or Breastfeeding women*.
    *Treatment with Metvix is not recommended during pregnancy. Breastfeeding should be discontinued during Metvix treatment and for 48 hours after treatment.
    Los pacientes que presenten alguno de los siguientes criterios de exclusión no podrán ser incluidos en el ensayo clínico:
    1. Hipersensibilidad a las sustancias activas del medicamento o cualquiera de sus excipientes (incluido si se es alérgico al cacahuete o la soja).
    2. Pacientes con porfiria.
    3. Mujeres embarazadas o en período de lactancia.*
    *No se recomienda el tratamiento con Metvix durante el embarazo. La lactancia debe interrumpirse durante el tratamiento con Metvix y durante las 48 horas siguientes al tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of QA on the side that is going to be applied cryotherapy
    2. Number of QA on the side that is going to be applied PDT-MAL-visible light
    3. Number of new QA on the side of cryotherapy
    4. Number of new QA on the side of the visible-light MAL-PDT
    5. Number of NMSC on the side of cryotherapy
    6. Number of NMSC on the side of the visible-light-MAL TFD
    7. Number of persistent QA on the side of cryotherapy
    8. Number of persistent QA on the side of the visible-light MAL-PDT
    1. Numero de QA en el lado en que se va a aplicar crioterapia
    2. Número de QA en el lado en que se va a aplicar TFD-MAL-luz visible
    3. Numero de QA nuevos en el lado de la crioterapia
    4. Número de QA nuevos en el lado de la TFD-MAL-luz visible
    5. Número de CCNM en el lado de la crioterapia
    6. Número de CCNM en el lado de la TFD-MAL-luz visible
    7. Numero de QA persistentes en el lado de la crioterapia
    8. Número de QA persistentes en el lado de la TFD-MAL-luz visible
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Number of AK on the side that is going to be applied PDT-MAL-visible light. V0.
    2. Number of AK on the side that is going to be applied cryotherapy. V0.
    3. Number of new AK on the side that is to be applied PDT-MAL-visible light. V3, V9, V15 and V21.
    4. Number of new AK on the side that is going to be applied cryotherapy. V3, V9, V15 and V21.
    5. Number of NMSC on the side that is going to be applied PDT-MAL-visible light. V3, V9, V15 and V21.
    6. Number of NMSC on the side that is going to be applied cryotherapy. V3, V9, V15 and V21.
    7. Number of persistent AK on the side that is going to apply PDT-MAL-visible light. V3, V9, V15 and V21.
    8. Number of persistent AK on the side that is going to be applied cryotherapy. V3, V9, V15 and V21.
    1. Numero de QA en el lado en que se va a aplicar TFD-MAL-luz visible. V0.
    2. Número de QA en el lado en que se va a aplicar crioterapia. V0.
    3. Numero de QA nuevas en el lado en que se va a aplicar TFD-MAL-luz visible. V3, V9, V15 y V21.
    4. Número de QA nuevas en el lado en que se va a aplicar crioterapia. V3, V9, V15 y V21.
    5. Numero de CCNM en el lado en que se va a aplicar TFD-MAL-luz visible. V3, V9, V15 y V21.
    6. Número de CCNM en el lado en que se va a aplicar crioterapia. V3, V9, V15 y V21.
    7. Numero de QA persistentes en el lado en que se va a aplicar TFD-MAL-luz visible. V3, V9, V15 y V21.
    8. Número de QA persistentes en el lado en que se va a aplicar crioterapia. V3, V9, V15 y V21.
    E.5.2Secondary end point(s)
    1. Presence of daylight-PDT-MAL of adverse effects.
    2. Presence of cryotherapy adverse effects.
    3. Ratings in quality of life scale (Skindex-29) for each of the sides.
    4. Patient preference (MAL-PDT in daylight / cryotherapy).
    5. Scale score tolerance for each of the two treated areas.
    6. Rating on the scale of satisfaction for each of the two areas treated.
    7. Cosmetic improvement of the 2 sides from baseline V0.
    1. Presencia de efectos adversos a la TFD-MAL-luz visible.
    2. Presencia de efectos adversos a la crioterapia.
    3. Puntacion en escala de calidad de vida (Skindex-29) para cada uno de los lados.
    4. Preferencia del paciente (TFD-MAL con luz de día/crioterapia).
    5. Puntuación en la escala de tolerancia para cada una de las dos áreas tratadas.
    6. Puntuación en la escala de satisfacción para cada una de las dos áreas tratadas.
    7. Mejoría cosmética de los 2 lados respecto al estado basal V0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Presence of daylight-MAL-PDT adverse effects. V0, V0b, V3, V3b, V9, V9b, V15, V21.
    2. Presence of cryotherapy adverse effects. V0, V0B, V3, V3b, V9, V9b, V15, V21.
    3. Ratings in quality of life scale (Skindex-29) for each side. V0 and V21.
    4. Patient preference (MAL-PDT in daylight / cryotherapy). V0b, V3b, V9b, V15 and V21.
    5. Rating on scale of tolerance for each of the two areas treated. V0b, V3b, V9b.
    6. Rating on the scale of satisfaction for each of the two areas treated V3, V9, V15, V21.
    7. Cosmetic improvement of the 2 sides cosmetics from baseline V0. V3, V9, V15, V21.

    V0b: Visit at 15 days from V0; V3b: Visit at 15 days from V3; V9b: Visit at 15 days from V9.
    1. Presencia de efectos adversos a la TFD-MAL-luz visible. V0, V0b, V3, V3b, V9, V9b, V15, V21.
    2. Presencia de efectos adversos a la crioterapia. V0, V0b, V3, V3b, V9, V9b, V15, V21.
    3. Puntacion en escala de calidad de vida (Skindex-29) para cada uno de los lados. V0 y V21.
    4. Preferencia del paciente (TFD-MAL con luz de día/crioterapia). V0b, V3b, V9b, V15 y V21.
    5. Puntuación en la escala de tolerancia para cada una de las dos áreas tratadas. V0b, V3b, V9b.
    6. Puntuación en la escala de satisfacción para cada una de las dos áreas tratadas V3, V9, V15, V21.
    7. Mejoria cosmetica de los 2 lados respecto al estado basal V0 mediante iconogracia. V3, V9, V15, V21.

    V0b: Visita a los 15 días de V0; V3b: Visita a los 15 días de V3; V9b: Visita a los 15 días de V9.
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Ciego para evaluador
    Blind for the evaluator
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Crioterapia
    Cryotherapy
    E.8.2.4Number of treatment arms in the trial0
    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
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    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)
    None
    Ninguno
    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 Decision2015-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-25
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