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    Summary
    EudraCT Number:2004-002526-22
    Sponsor's Protocol Code Number:03ES03-IMIQ
    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:2012-03-15
    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 number2004-002526-22
    A.3Full title of the trial
    Estudio piloto, fase IV(II), abierto, no controlado, unicéntrico con escalada de dosis, para evaluar la eficacia y seguridad de Imiquimod en pacientes con hemangioma infantil
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio para evaluar la eficacia y seguridad de Imiquimod en pacientes con hemangioma infantil
    A.4.1Sponsor's protocol code number03ES03-IMIQ
    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 SponsorInstituto Cientí­fico y Tecnológico de Navarra, S.A.
    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 support3M España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Científico y Tecnológico de Navarra
    B.5.2Functional name of contact pointGestor de ensayos clínicos
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Pío XII, 53
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number34948 176 748
    B.5.5Fax number34948 175 223
    B.5.6E-mailict@unav.es
    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 ALDARA
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA AB
    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 nameALDARA
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Yes
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Hemangioma Infantil
    E.1.1.1Medical condition in easily understood language
    Tumor vascular benigno caracterizado por un rápido crecimiento durante el primer año de vida, seguido de un periodo de involución que alcanza un grado variable y que dura varios años
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Evaluar la eficacia de Imiquimod en el tratamiento de hemangiomas en edad infantil
    E.2.2Secondary objectives of the trial
    1.- Evaluar la seguridad del tratamiento con Imiquimod en edad infantil, valorando la ausencia de afectación neuroógica.
    2.- Determinar la mejor pauta posológica para alcanzar el máximo beneficio en el tratamiento de los hemangiomas con Imiquimod
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Lactantes de ambos sexos, entre 1 y 12 meses de edad, con uno o más hemangiomas.
    2. Ausencia de alteraciones neurológicas.
    3. La superficie total del hemangioma será como máximo de 12 cm2 (si el paciente tiene varios hemangiomas, se pueden tratar hasta un máximo de 3, siempre que la superficie total a tratar no supere los 12 cm2).
    E.4Principal exclusion criteria
    1. Prematuros, nacidos antes de la semana 37 de gestación.
    2. Hemangiomas que comprometan la vida del paciente o que requieran un tratamiento inmediato por afectar a estructuras vitales.
    3. Hemangiomas localizados en el cuero cabelludo sobre una fontanela abierta.
    4. Los párpados sólo se excluirán si el tratamiento debe aplicarse sobre la conjuntiva o si el hemangioma afecta a la visión y requiere un tratamiento inmediato (cirugía o corticoesteroides).
    5. Hemangioma parotídeo.
    6. Hemangioma congénito (fase proliferativa completada al nacer).
    7. Presencia de ulceración.
    8. Tratamiento con esteroides sistémicos o tópicos en el mes anterior.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal del estudio será el grado de resolución del hemangioma, es decir, el % de superficie resuelta del hemangioma tras el tratamiento respecto al tamaño inicial. Se calculará la superficie cutánea afecta. En el caso de lesiones circulares se utilizara la fórmula de Ï?r2 y el caso de lesiones poligonales, se calculará la superficie multiplicando el diámetro mayor por el menor. Estas mediciones se llevarán a cabo con un calibrador milimétrico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 30 y 36 semanas tras la primera aplicación del tratamiento.
    E.5.2Secondary end point(s)
    1.- Porcentaje de pacientes que necesitaron ser tratados con la mayor dosis (tratamiento B).

    2.- Registro de acontecimientos adversos (AA) ocurridos durante el ensayo. Comprobar que no se asocian efectos secundarios importantes a este medicamento en este grupo de edad, en especial, los relacionados con las alteraciones neurológicas.

    3.- Otros parámetros a evaluar:
    - Volumen del hemangioma:
    ? El hemangioma se mantiene plano.
    ? El hemangioma estaba elevado antes del tratamiento pero se transforma en una lesión plana.
    ? El hemangioma pasa de plano a elevado durante el tratamiento.
    - Presencia de hemangioma residual.
    - Presencia de telangiectasias o vasos de drenaje residuales.
    - Presencia de tejido fibroadiposo o tejido redundante.
    - Presencia de cicatriz o atrofia.
    - Alopecia en los hemangiomas localizados en el cuero cabelludo.
    - Hiper o hipopigmentación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 30 y 36 semanas tras la primera aplicación del tratamiento. Se realizarán revisiones neurológicas y físicas en la visita basal, visita 1 (6 semanas), y a los 6, 12 y 18 meses de edad del paciente. En cada una de estas visitas también se valorará el hemangioma como en las anteriores visitas.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    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 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 No
    E.8.2.4Number of treatment arms in the trial1
    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
    La última visita del 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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Menores de edad
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    Tratamiento habitual de la patología
    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 Decision2004-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-07-31
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