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    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-005199-17
    Sponsor's Protocol Code Number:IIBSP-TIM-2013-156
    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:2014-04-25
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-005199-17
    A.3Full title of the trial
    Efficacy and safety of topical administration of timolol maleate 0.5% solution in the treatment of Child Proliferative Hemangioma Early Stage Surface. Randomized Controlled Study
    Eficacia y seguridad de la administración tópica de Timolol Maleato 0.5% solución en el tratamiento del Hemangioma Infantil Superficial en Etapa Proliferativa Temprana. Estudio Controlado Aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate efficacy and safety of topical administration of timolol maleate 0.5% solution in the treatment of Child Proliferative Hemangioma Early Stage Surface
    Estudio para evaluar la eficacia y seguridad de la administración tópica de Timolol Maleato 0.5% solución en el tratamiento del Hemangioma Infantil Superficial en Etapa Proliferativa Temprana
    A.4.1Sponsor's protocol code numberIIBSP-TIM-2013-156
    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 SponsorInstitut de Recerca HSCSP
    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 supportInstitut de Recerca HSCSP
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointEnrique Peña
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.4Telephone number34935537636
    B.5.5Fax number34935537812
    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. name Cusimolol
    D. of the Marketing Authorisation holderAlcon Cusi
    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 Eye drops, solution
    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 INNTIMOLOL
    D.3.9.1CAS number 26921-17-5
    D.3.9.3Other descriptive nameTIMOLOL MALEATE
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Children Superficial Hemangioma
    Hemangioma Infantil Superficial
    E.1.1.1Medical condition in easily understood language
    Children Superficial Hemangioma
    Hemangioma Infantil Superficial
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    To determine the efficacy of timolol maleate 0.5% solution in the treatment of infantile hemangiomas surface during the early proliferative stage.
    Analizar la eficacia del timolol maleato 0.5% en solución en la involución del hemangioma infantil en fase proliferativa temprana.
    E.2.2Secondary objectives of the trial
    - To analyze the effectiveness of timolol maleate 0.5%, expressed as complete / almost complete resolution of the HI at week 4, 12 and 24 compared to baseline.
    - To analyze the effectiveness of timolol maleate 0.5% by qualitative assessments in the center by parents or guardians
    - To analyze the persistence of efficacy 12 weeks after end of treatment
    - To analyze the safety profile and local tolerability of timolol maleate 0.5% solution in the treatment of HI
    - Analizar la eficacia de timolol maleato 0.5%, expresada como resolución completa/casi completa del HI en la semana 4, 12 y 24 en comparación con el período basal.
    - Analizar la eficacia de timolol maleato 0.5% mediante las evaluaciones cualitativas realizadas en el centro por los padres o tutores
    - Analizar la persistencia de la eficacia 12 semanas después del final del tratamiento
    - Analizar el perfil de seguridad y la tolerabilidad local del timolol maleato 0.5% solución en el tratamiento del HI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed Consent signed by a parent or guardian of the patient, both for study participation and for taking pictures.
    - The patient is 10 to 60 days old at the time of inclusion.
    - The patient should have at least:
    - A mixed both surface, sized from 0.3 to 5 cm in any location of the body surface focal or segmental hemangioma.; or
    - A hemangioma precursor defined as pink macules with white halo in periphery, clinically characteristic of the precursors of hemangiomas in infancy; or
    - A "abortion" or minimum defined as angiomas proliferation telangiectatic Hemangioma showing proliferation in <5% of the surface of the hemangioma
    - Firma de Consentimiento Informado por parte de los padres o tutores del paciente, tanto para la participación en el estudio como para la toma de fotografías.
    - El paciente debe de tener de 10 a 60 días de vida en el momento de inclusión.
    - El paciente deberá tener al menos:
    - Un hemangioma focal o segmentario, tanto superficiales como mixtos, de un tamaño entre 0,3 y 5 cm., en cualquier localización de la superficie corporal; o
    - Un precursor de hemangioma definido como máculas rosadas con halo blanquecino en periferia, clínicamente característico de los precursores de los hemangiomas en la infancia; o
    - Un Hemangioma ?abortivo? o de proliferación mínima definidos como angiomas telangiectásicos que muestran una proliferación en < 5% de la superficie del hemangioma
    E.4Principal exclusion criteria
    - Patients under 10 and over 60 days old at the time of inclusion.
    - Patients with indication of systemic therapy (ulcerated hemangiomas in mucosal surfaces, disfiguring)
    - Patients who are with another treatment modality for hemangiomas (beta blockers, corticosteroids, interferon, cyclophosphamide, vincristine)
    - Hemangiomas associated syndromes (PHACE, LUMBAR, SACRAL, PELVIS)
    - Hemangiomas affecting any organ or airway
    - Hemangiomas affecting any organ or airway
    - Patients with any underlying disease (bronchial asthma, severe lung disease, sinus bradycardia, atrioventricular block second degree, third degree, overt heart failure or cardiogenic shock).
    - Patients with congenital defects (patients with a chromosomal syndrome, patients with congenital heart disease (tetralogy of Fallot, transposition of the great arteries, ventricular septal defect, atrial septal defect, persistent ductus arteriosus)
    - Patients with neoplastic disease (leukemias, sarcomas, neuroblastoma, retinoblastoma, etc.)
    - Hypersensitivity to the active substance or any of the excipients.
    - Pacientes con menos de 10 y más de 60 días de vida en el momento de la inclusión.
    - Pacientes con indicación de terapia sistémica (hemangiomas ulcerados, en superficies mucosas, desfigurantes)
    - Pacientes que se encuentren con otra modalidad de tratamiento para hemangiomas (betabloqueantes, corticosteroides, interferón, ciclofosfamida, vincristina)
    - Hemangiomas asociados a Síndromes (PHACE, LUMBAR, SACRAL, PELVIS)
    - Hemangiomas que afecten algún órgano o vía aérea
    - Pacientes con alguna enfermedad de base (asma bronquial, enfermedad pulmonar grave, bradicardia sinusal, bloqueo auriculoventricular de segundo grado y tercer grado, insuficiencia cardiaca manifiesta o shock cardiogénico).
    - Pacientes con defectos congénitos (pacientes con algún síndrome cromosómico, pacientes con enfermedad cardiaca congénita (tetralogía de Fallot, transposición de grandes vasos, Comunicación interventricular, Comunicación interauricular, persistencia del ducto arterioso)
    - Pacientes con patología oncológica (Leucemias, sarcomas, neuroblastoma, retinoblastoma, etc)
    - Hipersensibilidad al principio activo o algunos de los excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for evaluating the efficacy of treatment is complete / almost complete resolution of the HI target at week 24 of treatment, which is defined as complete resolution of the lesion complete improvement and almost complete resolution is defined as the existence of a minimum degree of telangiectasia, erythema, dermal thickening, soft tissue swelling and / or distortion of anatomical references.
    La variable principal para evaluar la eficacia del tratamiento es la resolución completa/ casi completa del HI diana a la semana 24 de tratamiento, donde resolución completa se define como mejoría completa de la lesión y resolución casi completa se define como existencia de un grado mínimo de telangiectasia, eritema, engrosamiento cutáneo, tumefacción de partes blandas y/o distorsión de referencias anatómicas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    - Centralized independent qualitative assessments
    - Independent qualitative evaluations by the Investigator
    - Qualitative evaluations by parents / guardians
    - Evaluaciones cualitativas independientes centralizadas
    - Evaluaciones cualitativas independientes realizadas por el Investigador
    - Evaluaciones cualitativas realizadas por los padres/tutores
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 8, 12 and 24 weeks
    4, 8, 12 y 24 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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    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: 70
    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) Yes
    F. of subjects for this age range: 40
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F. of subjects for this age range: 30
    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. of subjects incapable of giving consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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)
    The expected normal treatment of that condition
    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 Decision2014-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-09
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