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    Summary
    EudraCT Number:2012-002863-88
    Sponsor's Protocol Code Number:LP0041-64
    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:2012-11-12
    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 number2012-002863-88
    A.3Full title of the trial
    A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with Actinic Keratosis on Face/Scalp and Trunk/Extremities
    Comparación de un régimen de Tratamiento simultáneo respecto a un régimen de tratamiento secuencial con Ingenol Mebutato Gel 0,015% y 0,05% de dos áreas con keratosis actínica en cara/cuero cabelludo y tronco/extremidades
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with Actinic Keratosis on Face/Scalp and Trunk/Extremities
    Comparación de un régimen de Tratamiento simultáneo respecto a un régimen de tratamiento secuencial con Ingenol Mebutato Gel 0,015% y 0,05% de dos áreas con keratosis actínica en cara/cuero cabelludo y tronco/extremidades
    A.4.1Sponsor's protocol code numberLP0041-64
    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 SponsorLEO PHARMA A/S
    B.1.3.4CountryDenmark
    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 supportLEO PHARMA A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO PHARMA France
    B.5.2Functional name of contact pointFlorence Preaud
    B.5.3 Address:
    B.5.3.1Street Address2, Rue René Caudron
    B.5.3.2Town/ cityVoisins-Le-Bretonneux
    B.5.3.3Post code78960
    B.5.3.4CountryFrance
    B.5.4Telephone number33130144000
    B.5.5Fax number33130144059
    B.5.6E-mailflorence.preaud@leo-pharma.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 Picato®
    D.2.1.1.2Name of the Marketing Authorisation holderLEO PHARMA A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIngenol mebutate gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIngenol Mebutate
    D.3.9.1CAS number 75567-37-2
    D.3.9.3Other descriptive nameINGENOL MEBUTATE
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.015
    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 Picato®
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameIngenol mebutate gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIngenol Mebutate Gel
    D.3.9.1CAS number 75567-37-2
    D.3.9.3Other descriptive nameINGENOL MEBUTATE
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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
    Keratosis actínica
    E.1.1.1Medical condition in easily understood language
    Actinic Keratosis
    Keratosis 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 14.1
    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
    To evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face or scalp and the other located on trunk or extremities) are treated with ingenol mebutate gel.

    The primary response criterion is the composite Local Skin Reaction (LSR) score 3 days after treatment start of each selected treatment area.
    Evaluar la seguridad de una pauta de tratamiento simultáneo en comparación con una pauta de tratamiento secuencial cuando se tratan dos zonas independientes con QA (una en la cara o en el cuero cabelludo y la otra en el tronco o en las extremidades) con gel de ingenol mebuta-to.
    El criterio principal de respuesta es la puntuación total de la reacción cutánea local (RCL) 3 días después del inicio del tratamiento en la zona de tratamiento seleccionada.
    E.2.2Secondary objectives of the trial
    To determine the efficacy and treatment satisfaction of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face or scalp and the other located on trunk or extremities) are treated with ingenol mebutate gel.
    Establecer la eficacia y la satisfacción con el tratamiento para un tratamiento simultáneo en comparación con una pauta de tratamiento secuencial cuando se tratan dos zonas independientes con QA (una en la cara o en el cuero cabelludo y la otra en el tronco o en las extremidades) con gel de ingenol mebutato.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures.
    2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on face or scalp.
    3. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities.
    4. Subject at least 18 years of age.
    5. Female subjects must be of either:
    a. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
    b. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
    6. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
    Effective contraception is defined as follows:
    - Oral/implant/injectable/transdermal/oestrogenic vaginal ring contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide.
    - Abstinence or partner?s vasectomy are acceptable if the female agrees to implement one of the other acceptable methods of birth control if her partner changes.
    1. Después de que se proporcione información verbal y escrita sobre el estudio, el paciente debe otorgar el consentimiento informado mediante la firma del documento de consentimiento informado (DCI), antes de que se realice cualquier procedimiento relacionado con el estudio.
    2. Pacientes que presenten entre 4 y 8 QA clínicamente significativas, visibles e independientes en una zona contigua de tratamiento de 25 cm2 en la cara o en el cuero cabelludo.
    3. Pacientes que presenten entre 4 y 8 QA clínicamente significativas, visibles e independientes en una zona contigua de tratamiento de 25 cm2 en el tronco o en las extremidades.
    4. Pacientes de al menos 18 años.
    5. En el caso de pacientes mujeres:
    a. No deben tener capacidad reproductora, p. ej., deben ser postmenopáusicas o debe confirmarse su esterilidad clínicamente (p. ej., la paciente no tiene útero) o,
    b. Si tienen capacidad reproductora, debe haberse obtenido un resultado negativo confirmado en una prueba de embarazo en orina antes del tratamiento del estudio, para descartar el embarazo.
    6. Las pacientes con capacidad reproductora deben estar dispuestas a utilizar un método anticonceptivo eficaz desde el momento de su admisión en el estudio y hasta el final del mismo. Un método anticonceptivo eficaz se define como:
    - Anticonceptivo oral/implante/inyectable/ transdérmico/anillo vaginal estrogénico, dispositivo intrauterino, preservativo con espermicida, diafragma con espermicida.
    - Se aceptan la abstinencia sexual o la vasectomía de la pareja de la paciente, si la paciente se compromete a aplicar cualquiera de los otros métodos anticonceptivos aceptables si se produce algún cambio.
    E.4Principal exclusion criteria
    1. Location of the selected treatment areas:
    ? on the periorbital skin,
    ? within 5 cm of an incompletely healed wound,
    ? within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
    2. Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities.
    3. Lesions in the selected treatment areas that have:
    ? atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or,
    ? recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
    4. History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum).
    5. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas.
    6. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator?s clinical judgment.
    7. Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications (see Exclusion Criteria Nos. 14-21).
    8. Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel.
    9. Presence of sunburn within the selected treatment areas.
    10. Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
    11. Subjects previously randomised in the trial.
    12. Female subjects who are breastfeeding.
    13. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
    1. Localización de las áreas de tratamiento seleccionadas:
    ? en la piel periorbitaria,
    ? a una distancia máxima de 5 cm de una herida cicatrizada de forma incompleta,
    ? a una distancia máxima de 10 cm de un posible carcinoma basocelular (CBC) o carcinoma epidermoide (CE).
    2. Tratamiento previo con gel de ingenol mebutato en la cara/cuero cabelludo y en el tronco/extremidades.
    3. Lesiones en las zonas de tratamiento seleccionadas que tengan:
    ? apariencia clínica atípica (p. ej., hipertrofia, hiperqueratosis o cuernos cutáneos) y/o,
    ? enfermedad resistente al tratamiento (p. ej., no respondieron a crioterapia en dos ocasiones anteriores).
    4. Antecedentes o indicios de enfermedades cutáneas diferentes a la indicación del estudio que puedan interferir en la evaluación de la medicación del estudio (p. ej., eccema, soriasis inestable, xerodermia pigmentosa).
    5. Uso de productos cosméticos o terapéuticos y procedimientos que pudieran interferir en las evaluaciones de las áreas de tratamiento seleccionadas.
    6. Antecedentes/diagnóstico clínico o signos de cualquier afección médica que pueda exponer al paciente a un riesgo excesivo de un AA significativo o interferir en las evaluaciones de la seguridad y eficacia durante el transcurso del estudio, según el juicio clínico del investigador.
    7. Necesidad prevista de hospitalización o cirugía ambulatoria durante los primeros 15 días tras la primera aplicación la medicación del estudio. Obsérvese que los procedimientos terapéuticos/cosméticos no se excluirán si quedan fuera de los criterios que se detallan en el apartado Medicamentos o tratamientos prohibidos (véanse los criterios de exclusión n.º 14-21).
    8. Sensibilidad conocida o alergia a cualquiera de los componentes del gel de ingenol mebutato.
    9. Presencia de quemaduras solares en las zonas de tratamiento seleccionadas.
    10. Inclusión o participación en un estudio clínico de investigación en los 30 días previos a la admisión en este estudio.
    11. Pacientes aleatorizados con anterioridad en el estudio.
    12. Pacientes en periodo de lactancia.
    13. A juicio del investigador, es improbable que el paciente cumpla el protocolo del estudio clínico (p. ej., alcoholismo, drogodependencia o estado psicótico).
    E.5 End points
    E.5.1Primary end point(s)
    Composite LSR score 3 days after treatment start of each selected treatment area
    Puntuación total de las RCL 3 días después del inicio del tratamiento en cada zona de tratamiento seleccionada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 days
    3 días
    E.5.2Secondary end point(s)
    ? TSQM after a treatment cycle of 8 weeks,
    ? Complete clearance of AKs in each separate treatment area 8 weeks after treatment,
    ? Partial clearance of AKs in each separate treatment area 8 weeks after treatment, defined as 75% or greater reduction in AKs from start of treatment to 8 weeks after treatment,
    ? Percent reduction in number of AKs in each separate treatment area 8 weeks after treatment.
    ? TSQM después de un ciclo de tratamiento de 8 semanas,
    ? Remisión completa de la QA en cada zona de tratamiento independiente 8 semanas después del tratamiento,
    ? Remisión parcial de la QA en cada zona de tratamiento independiente 8 semanas después del tratamiento, definida como una reducción del 75 % o más desde el inicio del tratamiento hasta 8 semanas después del tratamiento,
    ? Porcentaje de reducción del número de lesiones de QA en cada zona de tratamiento independiente 8 semanas después del tratamiento,
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    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) 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento simultaneo comparado con tratamiento secuencial con Ingenol Mebutate gel
    Simultaneous Treatment Compared to a Sequential Treatment with Ingenol Mebutate Gel 0.015% and 0.05%
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Treatment after the subject has ended the participation in the trial will be let up to Investigator judgement.
    Al final de la participación en el ensayo, el investigador establecerá, a su juicio, el tratamiento para el paciente
    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 Decision2013-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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