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    Summary
    EudraCT Number:2013-000110-37
    Sponsor's Protocol Code Number:PDT-DCF-1
    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:2013-03-06
    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 number2013-000110-37
    A.3Full title of the trial
    Clinical effectiveness and effect on COX-2 expression of the sequential treatment of actinic keratoses (AK) with photodynamic therapy (PDT) and diclofenac 3% gel: a phase IV clinical trial.
    Efectividad clínica y efecto sobre la expresión de COX-2 del tratamiento secuencial de queratosis actínicas con terapia fotodinámica y diclofenaco gel 3%. Ensayo clínico fase IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical effectiveness and effect on COX-2 expression of the sequential treatment of actinic keratoses (AK) with photodynamic therapy (PDT) and diclofenac 3% gel: a phase IV clinical trial
    Efectividad clínica y efecto sobre la expresión de COX-2 del tratamiento secuencial de queratosis actínicas con terapia fotodinámica y diclofenaco gel 3%. Ensayo clínico fase IV
    A.4.1Sponsor's protocol code numberPDT-DCF-1
    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 SponsorFundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid
    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 supportFIS 2012
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacion para la investigación biomédica del hospital Ramón y Cajal de Madrid
    B.5.2Functional name of contact pointDR JAEN OLASOLO
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Colmenar Viejo Km 9.100
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.6E-mailpedro@pjaen.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 Yes
    D.2.1.1.1Trade name SOLARAZE
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    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.3.4Pharmaceutical form Gel
    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 INNDICLOFENAC SODIUM
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    D.3.9.4EV Substance CodeSUB01674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 1.0
    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
    Queratosis actínica
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis
    Queratosis actínica
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to evaluate the effectiveness of the combination of PDT and topical 3% diclofenac gel in combination for treating AKs (using the reduction of at least 75% of the number of AKs as our primary endpoint) compared with the application of two sessions of PDT
    Evaluar la respuesta clínica, definida como la reducción de al menos un 75% de las queratosis actínicas (QA) tras tres meses de tratamiento, de la terapia combinada y secuencial con una sesión de TFD más diclofenaco al 3% frente al tratamiento convencional basado en dos sesiones de TFD en monoterapia
    E.2.2Secondary objectives of the trial
    We will also assess the impact of these treatment modalities on the expression of COX-2 and other oncogenic markers.
    To evaluate the development of adverse events after PDT and topical 3% diclofenac gel in combination for treating AKs compared with the application of two sessions of PDT
    Comparar la variación en la expresión de la COX-2, así como de marcadores oncogénicos, de proliferación y muerte celular en piel tratada con TFD y piel tratada con TFD/diclofenaco 3%, antes de aplicar el tratamiento y tres meses después de finalizado el mismo.
    Evaluar la seguridad del tratamiento de combinación TFD y diclofenaco en gel versus TFD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in the study should:
    1. Be 18 years or older.
    2. Give written informed consent after receiving adequate information about the design of the study, its objectives and the potential risks associated with their participation in the study.
    3. Be able to understand the aim of the study and be able to visit the hospital for the different consultations and follow-up visits.
    4. Have at least 5 nonhyperkeratotic AKs on the face and/or scalp
    5. Female patients agrees to use
    a double barrier method of contraception from the moment of signing
    the informed consent until 30 days after the end of treatment period
    Pacientes, que tras haber recibir información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento para participar en el estudio.
    Ser mayor de 18 años.
    Entender el propósito del estudio y estar disponibles para realizar frecuentes visitas al hospital
    Presentar al menos cinco QA no hipertróficas en región facial (excluyendo zonas peribucal y periocular) y/o cuero cabelludo.
    Ser candidato / tener indicación de recibir los tratamientos utilizados en este protocolo
    Mujeres en edad fértil que se comprometan a utilizar un método anticonceptivo de doble desde la firma del consentimiento informado hasta 30 días después de la última dosis del fármaco
    E.4Principal exclusion criteria
    pregnancy, breastfeeding, allergy to methyl aminolevulinate, AAS, diclofenac or to any of the excipients of these topical products, immunosuppression, porphyria, hereditary diseases that predispose to skin cancer (e.g. Gorlin syndrome, xeroderma pigmentosum), photosensitive disorders, photosensitizing treatments, previous treatments for AK in the three months prior to the beginning of the study (including imiquimod, PDT or any other therapy for AK), AKs in the perioral and periocular regions and the inability to follow the instructions or to collaborate during the development of the stud
    Embarazo, lactancia, alergia a MAL, AAS o diclofenaco, o alguno de los excipientes de los productos tópicos, inmunosupresión, porfiria, enfermedades hereditarias con predisposición a desarrollo de tumores cutáneos (sd Gorlin, xeroderma pigmentoso?), enfermedades fotosensibles, tratamientos fotosensibilizantes, tratamiento con imiquimod, TFD u otras terapias para QA en los últimos tres meses. Incapacidad para seguir las instrucciones o para colaborar durante el desarrollo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    ?significant clinical response?, defined as a more than 75% reduction in the number of initial AKs three months after finishing the treatments. This will be evaluated using visual examination and palpation by two different expert dermatologists, blinded to the administered treatments.
    "respuesta clínica significativa", definida como la reducción en el número de QA o lesiones sospechosas de QA en más de un 75%, tras tres meses de tratamiento, confirmadas con la visualización y la palpación por parte de dos facultativos expertos en Dermatología, que serán ciegos al tratamiento administrado
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    E.5.2Secondary end point(s)
    a. Complete histologic response, defined as the absence of histologic criteria of AK (normalization of the stratum corneum with no parakeratosis and normal maturation of epidermal keratinocytes with no atypical keratinocytes).
    b. Tolerance of treatment, evaluated a few minutes after illumination in the case of PDT and at month 3 of treatment in the case of topical 3% diclofenac. Patients will provide a general evaluation of treatment in terms of tolerance, including an evaluation of comfort, discomfort, pain, local skin reactions and other side effects. These evaluations will be scored on a visual analog scale of 0 to 10, where 0 represents well-tolerated treatment and 10 means very poorly tolerated treatment. The responses will be grouped as follows: 0 to 3, good tolerance; 4 to 7, acceptable tolerance; and 8 to 10, poor tolerance. Patients receiving PDT and topical 3% diclofenac will score each of the treatments separately in the same way as described previously.
    c. Security measures: every patient will be asked to write down any incidence he/she may experience during the study, including adverse effects, need to apply or take any treatments for any adverse reactions, etc. For that purpose, every patient will be given a notebook, which will be collected at the final visit of the study.
    d. Adverse events:
    i. Proportion of patients who develop local symptoms related to the treatments.
    ii. Proportion of patients who develop any systemic adverse reaction(s) related to the treatments.
    e. Proportion of patients with recurrences 12 months after finishing treatments.
    f. Proportion of patients who develop other non-melanoma skin cancers on the treated areas during the 12 months after finishing the treatments.
    g. Study of the expression of COX2 and other oncogenic, proliferative and apoptotic markers by immunohistochemistry, evaluated by two different pathologists.
    ? ?Respuesta histológica completa", definida como ausencia de criterios histológicos de QA (normalización del estrato córneo con ausencia de paraqueratosis y maduración normal de queratinocitos, sin queratinocitos atípicos).
    ? Variables de seguridad:
    o Medidas de tolerancia: se determinará la tolerancia a la TFD tras la iluminación y al tratamiento con diclofenaco tópico al finalizar el período de aplicación del fármaco (a los 90 días). Se interrogará a los pacientes sobre la tolerancia al tratamiento, incluyendo molestias, dolor, reacciones cutáneas locales, efectos adversos sistémicos. Se utilizará una escala analógica visual de 0 a 10 para evaluar la tolerancia, donde el 0 representará una buena tolerancia al tratamiento y el 10 mala tolerancia. Se agruparán las respuestas en tres categorías: entre 0 y 3 se considerará una buena tolerancia, entre 4 y 6, tolerancia aceptable, y los valores iguales o superiores a 7 serán considerados como mala tolerancia. En el caso de los pacientes sometidos al tratamiento secuencial, tendrán que valorar la tolerancia a los dos tratamientos por separado de la forma descrita.
    o Medidas de seguridad: Cada paciente recibirá un cuaderno de anotaciones o "cuaderno del paciente", donde podrá anotar diariamente cualquier incidencia que considere durante el desarrollo del estudio, así como las reacciones adversas experimentadas, la necesidad de aplicación o consumo de algún fármaco por reacciones adversas del tratamiento, etc. El cuaderno será recogido en la última visita del estudio
    ? Eventos adversos que puedan asociarse al tratamiento:
    o Proporción de pacientes con síntomas locales.
    o Proporción de pacientes con síntomas sistémicos que puedan asociarse al tratamiento.
    ? Recurrencia de QA en las zonas tratadas a los doce meses después de finalizado el tratamiento
    ? Proporción de pacientes que desarrollan otras lesiones de cáncer cutáneo no melanoma en las zonas tratadas a los doce meses de tratamiento
    ? Determinación de la expresión de COX-2 y marcadores oncogénicos, de proliferación y muerte celular en la biopsia cutánea pre- y post-tratamiento mediante técnicas de inmunohistoquímica, por dos evaluadores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tratamiento secuencial con terapia fotodinámica
    sequential treatment with photodynamic therapy
    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
    El estudio finalizará cuando el última paciente reclutado realice la
    última visita de 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
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state130
    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.
    El paciente será trtado conforme a la práctica clínica habitual
    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 Decision2013-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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