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    Summary
    EudraCT Number:2010-024078-20
    Sponsor's Protocol Code Number:RSW2011
    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:2010-12-15
    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 number2010-024078-20
    A.3Full title of the trial
    Ensayo clínico fase II, aleatorizado, triple ciego, controlado intraindividualmente con placebo, para evaluar la eficacia y seguridad de la rapamicina tópica sola o asociada a láser de colorante pulsado en pacientes con síndrome de Sturge-Weber
    A.4.1Sponsor's protocol code numberRSW2011
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstituto Científico y Tecnológico 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameRapamicina tópica al 1% y excipiente
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNcrema de rapamicina al 1% y excipientes
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 No
    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 nameCrema placebo (excipiente)
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCrema placebo (excipiente)
    D.3.10 Strength
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeCrema placebo (excipiente)
    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 placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Malformación capilar cutánea en pacientes con síndrome de Sturge-Weber.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level PT
    E.1.2Classification code 10042265
    E.1.2Term Síndrome de Sturge-Weber
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Determinar la eficacia clínica del tratamiento con rapamicina tópica o rapamicina tópica respecto a láser PDL sólo o placebo en las MC de los pacientes con SSW mediante un sistema de análisis informático morfológico de imagen digital (eficacia medida como porcentaje de disminución del área), cromatográfico (eficacia medida como disminución del color rojo/rosa) y espectometría (eficacia medida como disminución del índice de hemoglobina) realizado en situación basal, a las 6, 12 y 18 semanas.
    - Determinar mediante estudios inmunohistoquímicos la eficacia histológica (medida como disminución del número de vasos y de marcadores de proliferación endotelial) con el tratamiento de rapamicina tópica sola o rapamicina con láser PDL respecto a láser PDL sólo o placebo en las MC de pacientes con SSW comparando biopsias cutáneas a las 12 semanas.
    E.2.2Secondary objectives of the trial
    - Evaluar la seguridad de la rapamicina tópica al 1% administrada una vez al día durante tres meses, mediante un control analítico básico empleado en la monitorización del fármaco cuando se administra por vía oral y la medición de los niveles plasmáticos de rapamicina a las 6 semanas del inicio del tratamiento.
    - Evaluar la tolerancia local y aparición de reacciones cutáneas locales mediante la escala visual de Frosch y Kligman (ver anexo 3 adjunto).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hombres y mujeres con una edad >18 y <65 años en el momento del consentimiento.
    - Diagnóstico de síndrome de Sturge-Weber.
    - Afectación facial por una malformación facial capilar.
    - Capacidad para comprender y deseo de otorgar voluntariamente el consentimiento informado por escrito, firmado y fechado, antes de la práctica de cualquier procedimiento específico del protocolo.
    - En el caso de mujeres potencialmente fértiles: uso de un método anticonceptivo de elevada eficacia reconocida, es decir, que arroje una baja tasa de fracaso: menos del 1% al año (anticonceptivos orales, dispositivo intrauterino, implantes, pareja vasectomizada o abstinencia sexual), durante un mínimo de 3 meses consecutivos antes del estudio, a lo largo del estudio y 3 meses siguientes al término del estudio.
    E.4Principal exclusion criteria
    - Pacientes diagnosticados de SSW sin malformación capilar facial.
    - Pacientes con otra enfermedad cutánea que afecte el área a tratar.
    - Pacientes que se apliquen cualquier tratamiento tópico o cosmético en la zona a tratar.
    - Pacientes diagnosticados de neoplasias activas u otro proceso concomitante importante.
    - Tratamiento intervencionista concomitante que pudiera influir de manera independiente en el desenlace del ensayo, tal y como tratamiento con láser o cirugía sobre el área a tratar.
    - Tratamiento con inmunosupresores (sino se hubieran administrado a una dosis estable durante al menos tres meses antes de la selección).
    - Uso de fármacos antiangiogénicos tanto tópica como sistémicamente (bevacizumab, trastuzumab, sorafenib, erlotinib, talidomida, imiquimob, interferon-alfa2b...)
    - Mujeres embarazadas o en periodo de lactancia.
    - Hipersensibilidad al fármaco o a cualquiera de sus excipientes.
    - Expectativa razonable de que el sujeto no vaya a poder completar satisfactoriamente el estudio:
    1-Antecedente o presencia de enfermedad psiquiátrica grave que pudiera interferir en la capacidad del sujeto para cumplir los requisitos del protocolo o para otorgar su consentimiento informado.
    2-Antecedentes de alcoholismo o drogadicción que pudiera interferir en la capacidad del sujeto para cumplir los requisitos del protocolo.
    - Recepción de algún producto en investigación en los tres meses previos a la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    - Medidas de efectividad del tratamiento: porcentaje de reducción de la superficie de la lesión y disminución de la coloración roja/rosa basal (mediante MatLab Software Licence®), decrecimiento del índice de saturación de la hemoglobina (según Espectrómetro S 3B Scientific®) y disminución histológica del número de vasos sanguíneos y de los parámetros de proliferación endotelial estudiados.

    - Medidas de seguridad del principio activo: biodisponibilidad plasmática de rapamicina tópica al 1% en adultos (técnica CMIA, autoanalizador Architect Abbot®), alteración de las variables analíticas solicitadas, efectos adversos generales (alteración de la tensión arterial y frecuencia cardíaca, y la presencia de otra sintomatología sistémica durante el tratamiento) y tolerancia local de los productos según la escala visual de Frosh y Kligman.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Triple ciego, controlado intraindividualmente
    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.8.3 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 Information not present in EudraCT
    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
    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 months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state23
    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 Decision2011-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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