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    Summary
    EudraCT Number:2014-003339-21
    Sponsor's Protocol Code Number:VEPLAN-2014-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-27
    Trial 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 number2014-003339-21
    A.3Full title of the trial
    Open, randomized, with two parallel treatment groups combined therapy
    with bleomycin and with bleomycin electrochemotherapy (EQ) in patients
    with plantar warts large clinical trial virus.
    Diagnosis and monitoring with confocal microscopy.
    Ensayo clínico abierto, aleatorizado y con dos grupos paralelos de
    tratamiento con bleomicina o tratamiento combinado de bleomicina con
    electroquimioterapia (EQ) en pacientes con verrugas virales plantares de
    gran tamaño.
    Diagnóstico y seguimiento con microscopia confocal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in patients with plantar viral warts treated with topical bleomycin or
    bleomycin and electrochemotherapy
    Estudio en pacientes con verrugas víricas plantares, tratados con
    bleomicina tópica o con bleomicina y electroquimioterapia
    A.3.2Name or abbreviated title of the trial where available
    VEPLAN
    VEPLAN
    A.4.1Sponsor's protocol code numberVEPLAN-2014-01
    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 d'Investigació Sanitària Pere Virgili (IISPV)
    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 supportNO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Estudios Clínicos IISPV
    B.5.2Functional name of contact pointCoordinator
    B.5.3 Address:
    B.5.3.1Street AddressAvda. de la Universitat, 1
    B.5.3.2Town/ cityReus (Tarragona)
    B.5.3.3Post code43204
    B.5.3.4CountrySpain
    B.5.4Telephone number34977759394
    B.5.5Fax number34977759394
    B.5.6E-mailsreverte@fiispv.cat
    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.2.5The 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 nameBleomicina
    D.3.2Product code 49313
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Intralesional use
    Transdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBLEOMYCIN
    D.3.9.1CAS number 11056-06-7
    D.3.9.4EV Substance CodeSUB00842MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000
    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 Yes
    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 placeboCutaneous solution
    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
    viral wart
    verruga vírica
    E.1.1.1Medical condition in easily understood language
    viral wart
    verruga vírica
    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 evaluate the safety and efficacy of two parallel treatment groups versus intralesional bleomycin group EQT treatment with intralesional bleomycin for plantar warts, through pre and post treatment (clinical examination and confocal microscopy (RCM)) evaluations to confirm their progression and degree of remission or ultimate demise.
    Evaluar la seguridad y eficacia de dos grupos paralelos de tratamiento de bleomicina intralesional por EQT versus un grupo de tratamiento con bleomicina intralesional para las verrugas plantares, mediante evaluaciones pre y post tratamiento (examen clínico y microscopia confocal (MCR)) para confirmar su progresión y grado de remisión o desaparición definitiva.
    E.2.2Secondary objectives of the trial
    1 Study the TEQ-bleomycin treatment versus control group with intralesional bleomycin treatment for plantar warts using pre and post treatment (clinical examination and MCR) evaluations to confirm their progression and degree of remission or ultimate demise.
    2 Assess the degree of safety of the treatment in both groups at 3 months by the presence of potential adverse effects to treatment.
    3 Evaluate the effectiveness of treatment in both groups at 3 months by reducing the size of the wart or missing images obtained with confocal microscopy and clinics.
    4 Study the treatment group to present less pain compared to plantar warts before and after treatment, using the "EVA" pain scale.
    1. Estudiar el tratamiento EQT-bleomicina versus un grupo control de tratamiento con bleomicina intralesional para las verrugas plantares, mediante evaluaciones pre y post tratamiento (examen clínico y MCR) para confirmar su progresión y grado de remisión o desaparición definitiva.
    2. Evaluar el grado de seguridad del tratamiento en ambos grupos a los 3 meses mediante la presencia de posibles efectos adversos al tratamiento.
    3. Evaluar el grado de eficacia del tratamiento en ambos grupos a los 3 meses mediante la reducción del tamaño de la verruga o desaparición obtenida con imágenes de microscopia confocal y clínicas.
    4. Estudiar el grupo de tratamiento que presente menos dolor con relación a las verrugas plantares pre y post tratamiento, mediante la escala ?EVA? del dolor.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Age ? 18 years.
    b) Signed informed consent.
    c) Histological confirmation of wart / s plantar / is viral / s.
    d) Patients belonging to the area of specialized care of Dermatology Department of Pius Hospital de Valls.
    e) Failure of previous conventional treatments (cryosurgery, surgery, electrocautery, topical immunomodulators).
    f) Minimum size of the plantar wart: 0.5 cm.
    g) Presence of single lesion or multiple lesions equal to or greater than 3 cm distance between them in the foot (both included).
    h) Ability of patients to follow instructions
    a) Edad ? 18 años.
    b) Consentimiento informado firmado.
    c) Confirmación histológica de verruga/s plantar/es viral/es.
    d) Pacientes que pertenezcan al area de atención especializada del Servicio de Dermatología del Píus Hospital de Valls.
    e) Fallo de tratamientos convencionales previos (criocirugía, cirugía, electrocoagulación, inmunomoduladores tópicos).
    f) Tamaño mínimo de la verruga plantar: 0.5 cm.
    g) Presencia de lesión única o múltiples lesiones de igual o superior a 3 cm de distancia entre las mismas en la planta del pie (ambos incluidos).
    h) Capacidad de los pacientes de seguir instrucciones
    E.4Principal exclusion criteria
    a) Background Raynauld phenomenon, peripheral vascular disease or collagen disease known.
    b) known heart disease
    c) Previous use of bleomycin
    d) No informed consent signed or removal thereof
    e) Pregnancy or lactation
    a) Antecedentes de Fenómeno de Raynauld, enfermedad vascular periférica o enfermedad del colágeno conocida.
    b) Cardiopatias conocidas
    c) Uso previo de bleomicina
    d) No obtención del consentimiento informado firmado o retirada del mismo
    e) Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Therapeutic improvement in the treatment group 50% of plantar warts virus.
    Therapeutic improvement in the control group 20% of plantar warts virus.
    Mejora terapéutica en el grupo de tratamiento de un 50 % de las verrugas virales plantares.
    Mejora terapeutica en el grupo control del 20% de las verrugas virales plantares.
    Presencia de efectos adversos en el grupo de tratamiento similar a la literatura.
    Presencia de dolor similar en los dos grupos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Therapeutic improvement in the treatment group 50% of plantar warts virus: evaluated using lesion volume confocal microscope.
    Therapeutic improvement in the control group 20% of plantar warts viral: evaluated using lesion volume confocal microscope.
    Mejora terapéutica en el grupo de tratamiento de un 50 % de las verrugas virales plantares: valorado mediante volumen de la lesión con microscopio confocal.
    Mejora terapeutica en el grupo control del 20% de las verrugas virales plantares:valorado mediante volumen de la lesión con microscopio confocal.
    E.5.2Secondary end point(s)
    Therapeutic improvement in the control group 20% of plantar warts viral: evaluated using lesion volume confocal microscope.
    Presence of adverse effects similar to group therapy literature: monitoring of adverse events and serious adverse effects during the study and one month after treatment in both groups.
    Presence of similar pain in both treatment groups: VAS assessment of pain in both groups, pre and post treatment
    Presencia de efectos adversos en el grupo de tratamiento similar a la literatura: monitorización de los efectos adversos y efectos adversos graves durante el estudio y un mes despues del tratamiento en ambos grupos.
    Presencia de dolor similar en los dos grupos de tratamiento: valoración de la escala EVA del dolor en los dos grupos, pre y post tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline evaluations during treatment delivery and outcome of treatment in both groups. In case of adverse events or serious adverse events follow one month after the study ended.
    Evaluaciones basales, durante la administración del tratamiento y al finalizar el tratamiento en ambos grupos. En caso de efectos adversos o efectos adversos graves seguimiento un mes despues de finalizar el estudio.
    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 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) 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 No
    E.8.1.6Cross over Yes
    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
    Is the last visit
    es la última visista del paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days30
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 Information not present in EudraCT
    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 state84
    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)
    Routine clinical practice
    Práctica clínica habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Instituto de Investigación Sanitaria Pere i Virgili
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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