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    Summary
    EudraCT Number:2015-002408-97
    Sponsor's Protocol Code Number:MALvsALA
    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:2015-10-05
    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 number2015-002408-97
    A.3Full title of the trial
    Comparative Study, intraindividual to evaluate efficacy and safety of the treatment of actinic keratosis with photodinamic therapy between methyl aminolevulinate cream and aminolevulinic acid nanosome gel
    Estudio comparativo, intraindividual, sobre la eficacia y seguridad del tratamiento de las queratosis actínicas con terapia fotodinámica entre metilaminolevulinato en crema y ácido aminolevulínico nanosomado en gel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare efficacy and safety between two treatments for actinic queratosis
    Estudio para comparar eficacia y seguridad entre dos tratamientos para la queratosis actínica.
    A.4.1Sponsor's protocol code numberMALvsALA
    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 SponsorDr. Carlos Serra
    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 supportServicio Dermatología FIVO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMarketing Farmacéutico & Investigación Clinica
    B.5.2Functional name of contact pointFederico Nepote
    B.5.3 Address:
    B.5.3.1Street AddressSecretari Coloma 64-68 esc. Bentlo 5º
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934344412
    B.5.5Fax number0034932531168
    B.5.6E-mailinvestigacion@mfar.net
    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 holderLaboratorios Galderma, 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
    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 HYDROCHLORIDE
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21579
    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.IMP: 2
    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 Ameluz
    D.2.1.1.2Name of the Marketing Authorisation holderBiofrontera Bioscience GmbH
    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
    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 INN5-aminolevulinic acid
    D.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21578
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number78
    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
    An actinic keratosis is a rough and scaly patch or growth that forms on the skin that soaks up lots of sun over the years
    la queratosis actínica es una pequeña área elevada y áspera que se encuentra en partes de la piel que han estado expuestas al sol durante mucho tiempo.
    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 18.0
    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
    To compare MAL with the new photosensitizer BF-200 ALA in terms of local reaction and tolerability of the QA treatment
    Comparar el MAL con el nuevo fotosensibilizante BF-200 ALA en términos de reacción local y tolerancia para el tratamiento de las QA.
    E.2.2Secondary objectives of the trial
    To compare the efficacy and characteristics of the fluorescence emision between the two photosensitizers
    Comparar la eficacia y las características de la emisión de fluorescencia entre los dos fotosensibilizantes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible patients may present at least 5 QA in two symmetrical areas of the face or the scalp. Can not be significant differences in the number QAs between the two treatment areas.

    1. Patients older than 18 years and able to give informed consent.
    2. Patients must have at least 5 QA in two symmetrical areas of the face or the scalp.
    3. Patients must no use solar protection creams or other creams (retinoic, hydroxiacids, emollients, topic antibiotics) on the treatment area during the study time.
    4. Patients must agree to postpone the treatment of the other actinic keratosis lesions close to the treatment area.
    5. Patients must agree going to the scheduled visits where they have to complete a form with epidemiology aspects, baseline characteristics, and satisfaction with the treatment received and taking pictures of the treatment area on each visit.
    Los pacientes elegibles deberán presentar al menos 5 QA en dos zonas simétricas de la cara o cuero cabelludo, entre las dos zonas de tratamiento no puede haber una diferencia importante en el número de QAs.

    1. Paciente mayor de 18 años capaz de dar consentimiento informado
    2. Presentar al menos 5 QA en dos zonas simétricas de la cara o cuero cabelludo..
    3. Aceptar el abandono de cremas de protección solar y otro tipo de cremas (retinoico, hidroxiácidos, emolientes, antibióticos tópicos) en la zona de tratamiento durante el tiempo que dura el estudio.
    4. Aceptar que se va a posponer el tratamiento de otras queratosis actínicas próximas al área de tratamiento.
    5. Aceptar que debe acudir a las visitas programadas donde deberá realizar un cuestionario de aspectos epidemiológicos, antecedentes y satisfacción del tratamiento así como la realización de fotografías de la zona de tratamiento en cada visita.
    E.4Principal exclusion criteria
    Perioral and periocular areas of the face will be discarded as treatment zones. Patients with previous treatment with photodynamic therapy in the face or the scalp for any lesion. Patients with previous treatment for actinic keratosis in the previous 3 months, patients with inmunosuppression treatment, and patients with inherited diseases which can predispose to cutaneous cancer (Gorlin syndrome, xeroderma pigmentosum.
    1. Patients who have clinical evidence of inmunosuppression, unstable cardiovascular diseases, haematological, hepatic, neurological, renal or endocrine diseases. Patients with stables medical conditions like high blood pressure. diabetes mellitus, hypercholesterolemia, etc. can be included in the study.
    2. Patients who suffer form any dermatological disease in the treatment zone or around it.
    3. Patients who have received previous treatment with photodynamic therapy in the selected areas.
    4. Patients who have alcohol or drug dependency.
    5. Being currently participating in other studies
    6. Patients who have received any of the following treatments in less time than indicated:
    - Systemic chemotherapy, in the last 6 months
    - Systemics retinoids, interferon, inmunomodulators or inmunosuppressors, cytotoxic agents, systemic corticoids, in the last month
    - PUVA, UVB, ablative lasers, dermabrasion, chemical peelings, in the last 6 months
    - Topic retinoids, topic 5-fluorouracil, in the last month.
    - Cryotherapy, surgical extirpation, curettage, topic corticoids, in the last month
    Se descartarán como zonas de tratamiento la zona perioral y periocular de la cara. Se excluirán a los pacientes que hayan sido tratados previamente con TFD en la cara o el cuero cabelludo para cualquier lesión, que hayan recibido cualquier otro tratamiento para QA en los 3 meses previos, pacientes con tratamiento inmunosupresor y pacientes con enfermedades hereditarias que predisponen al cáncer cutáneo (síndrome de Gorlin, xeroderma pigmentoso).

    1. Tener evidencia clínica de inmunosupresión, enfermedades inestables cardiovasculares, hematológicas, hepáticas, neurológicas, renales, endocrinas. Los pacientes no deben tener evidencia de cáncer sistémico o inmunosupresión. Los pacientes con enfermedades médicas estables como hipertensión, diabetes mellitus, hipercolesterolemia etc pueden formar parte del estudio.
    2. Tener cualquier enfermedad dermatológica en la zona de tratamiento o alrededor de la misma.
    3. Pacientes que previamente han recibido tratamiento con terapia fotodinámica en las zonas seleccionadas
    4. Pacientes con dependencia a alcohol o drogas
    5. Estar actualmente participando en o en otros estudios
    6. Haber recibido cualquiera de las siguientes medicaciones en un tiempo menor al señalado
    - Quimioterapia sistémica, en los últimos 6 meses.
    - Retinoides sistémicos, interferón, inmunomoduladores o inmunosupresores, -agentes citotóxicos,corticoides sistémicos, en el último mes.
    - PUVA, UVB, Láser ablativos, Dermoabrasión, peelings químicos, en los últimos 6 meses
    - Retinoides tópicos, 5 fluoracilo tópico, en el último mes.
    - Crioterapia, extirpación quirúrgica, curetaje, corticoides tópicos, en el último mes.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response will be assessed with the help of the basal photograph and the transparent template. Partial Response (PR) is defined as the resolution of ?75% of the initial actinic keratosis lesions. Complete Response (CR) is defined as the resolution of 100% of the initial actinic keratosis lesions.

    Patients will be asked about the pain suffered in both sides just after the illumination. Pain will be quantified with an analogical scale of 10 cm. Patients will mark a point between 0 (no pain) and 10 (maximum imaginable pain)

    Retarded local reaction measurement: immediate local reaction to the illumination can comprehend, in different grades: erythema, inflammation and swelling. Will be quantified in a scale from 0 to 10, where 0 is normal skin, without local reaction, and 10 a maximum local reaction. Retarded local reaction defined by the presence in higher or lower grades of erythema, inflammation and swelling, scabs and pustules, will be quantified from 0 to 10 where 0 is normal skin, without local reaction, and 10 a maximum local reaction
    La respuesta clínica se evaluará con la ayuda de la fotografía inicial y la plantilla transparente. Se define respuesta parcial (RP) si se resuelven ?75% de las QA iniciales y respuesta completa (RC) si se resuelven el 100% de las mismas.

    Tras finalizar la iluminación los pacientes serán interrogados acerca del dolor que hayan padecido en ambos lados. Para ello se cuantificará el dolor mediante una escala visual analógica de 10 cm y los pacientes señalarán un punto entre 0 (ningún tipo de dolor) y 10 (máximo dolor imaginable).

    Medición reacción local tardía: La reacción local inmediata a la iluminación podrá comprender en mayor o menor grado eritema, inflamación y edema. Se puntuará en una escala de 0 a 10 dónde 0 será piel normal, sin reacción local y 10 una reacción local máxima. La reacción local tardía definida por la presencia en mayor o menor grado de eritema, inflamación, edema, costras y pústulas, también se puntuará de 0 a 10 dónde 0 será piel normal, sin reacción local y 10 una reacción local máxima.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response will be assessed at day 30 after the photodynamic therapy.

    Pain will be assessed just after the photodynamic therapy.

    Retarded local reaction measurement will be assessed at day 2-3 after the photodynamic therapy.
    La respuesta será evaluada en el día 30 tras la terapia fotodinámica.

    El dolor será evaluado justo después de la terapia fotodinámica.

    La medición de la reacción local tardía se realizará a los 2-3 días tras la terapia fotodinámica.
    E.5.2Secondary end point(s)
    Fluorescence measurement: fluorescence will be studied with a Wood light lamp, immediately before the illumination and will be measured from 0 to 10, where 0 is an absolute absence of fluorescence, 5 is a limited and selective fluorescence in the actinic keratosis lesions and 10 is a fluorescence in the complete area of treatment where the photosensitizer was applied.
    Medición de fluorescencia: La fluorescencia se estudiará con una lámpara de luz de Wood inmediatamente antes de la iluminación y ésta podrá puntuarse desde 0 hasta 10, dónde 0 era una ausencia absoluta de fluorescencia, 5 una fluorescencia limitada y selectiva en las lesiones de QA y 10 una fluorescencia en toda la zona de tratamiento donde se había aplicado el fotosensibilizante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Fluorescence measurement will be assesed just before the photodynamic therapy.
    La medición de fluorescencia se realizará justo antes de la terapia fotodinámica.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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
    Aleatorización intrapaciente del área/tratamiento. Enmascarado para el evaluador de la respuesta
    Intrapatient randomization of treatment/area. Blinded to the response evaluator
    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
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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: 50
    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 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 state50
    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)
    Patients will receive the expected normal treatment of the disease.
    Los pacientes recibirán el tratamiento habitual para su enfermedad.
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
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