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    Summary
    EudraCT Number:2022-000842-14
    Sponsor's Protocol Code Number:TBCH2022
    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:2022-03-28
    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 number2022-000842-14
    A.3Full title of the trial
    Trial study to evaluate the effectiveness of botulinum toxin A (incobotulinumtoxin) injection in reducing the pain and size of painful scars (including hypertrophic and keloid scars)
    Estudio para evaluar la efectividad de la inyección de toxina botulínica A (incobotulinumtoxina) para reducir el dolor y tamaño de las cicatrices dolorosas (incluyendo cicatrices hipertróficas y queloides)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of botulinum toxin A injection in reducing the pain and size of painful scars
    Efectividad de la inyección de toxina botulínica A para reducir el dolor y tamaño de las cicatrices dolorosas
    A.3.2Name or abbreviated title of the trial where available
    painful scars
    cicatrices dolorosas
    A.4.1Sponsor's protocol code numberTBCH2022
    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 SponsorDra.Margarita Ramirez&Dra.Ifara Sánchez
    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 supportNA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDra.Ifara Sánchez
    B.5.2Functional name of contact pointDra.Ifara Sánchez
    B.5.3 Address:
    B.5.3.1Street AddressCrta. Rosario Nº 145
    B.5.3.2Town/ citySanta Cruz de Tenerife
    B.5.3.3Post code38010
    B.5.3.4CountrySpain
    B.5.6E-mailifaraperdomo@hotmail.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 Xeomin®
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharma España S.L.
    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 nameIncobotulinumtoxinA
    D.3.2Product code IncobotulinumtoxinA
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBOTULINUM TOXIN TYPE A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeTBCH2022
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 200
    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
    painful scars
    Cicatrices dolorosas
    E.1.1.1Medical condition in easily understood language
    painful scars
    Cicatrices dolorosas
    E.1.1.2Therapeutic area Not possible to specify
    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
    The main objective of the study is to verify the efficacy (measured by the Visual Analogue Scale, VAS) of incobotulinum toxin A, at 8 weeks, for the treatment of painful scars, including hypertrophic and keloid scars.
    El objetivo principal del estudio es comprobar la eficacia (medida mediante la Escala Visual Analógica, EVA) de la toxina incobotulínica A, a las 8 semanas, para el tratamiento de las cicatrices dolorosas, incluyendo cicatrices hipertróficas y queloides.
    E.2.2Secondary objectives of the trial
    -Treatment efficacy (as measured by the VAS pain rating scale) with incobotulinum toxin A at 4 weeks and 6 months post-injection for the treatment of painful scars, including hypertrophic and keloid scars.
    -Vancouver Scars Scale (VSS), which contains the following 4 components:
    a) Melanin pigmentation (0-3 points),
    b) scar height (0-3 points),
    c) vascularization (0-3 points) and
    d) flexibility (0-5 points),
    with a maximum score of 14 points indicating the greatest severity of the scar
    -Consumption of analgesics for which a diary will be provided to collect the usual analgesic medication.
    -Assess the safety and tolerability of treatment.
    -Eficacia del tratamiento (medida mediante la escala de evaluación del dolor EVA) con toxina incobotulínica A a las 4 semanas y 6 meses tras la inyección para el tratamiento de las cicatrices dolorosas, incluyendo cicatrices hipertróficas y queloides.
    -Vancouver Scars Scale (VSS), que contiene los siguientes 4 componentes:
    a) Pigmentación de melanina (0-3 puntos),
    b) altura de la cicatriz (0-3 puntos),
    c) vascularización (0-3 puntos) y
    d) flexibilidad (0-5 puntos),
    con una puntuación máxima de 14 puntos que indican la mayor gravedad de la cicatriz
    -Consumo de analgésicos para lo cual se facilitará un diario para recogida de medicación analgésica habitual.
    -Valorar la seguridad y tolerabilidad del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Over 18 years old.
    -With hypertrophic or keloid painful scar
    -Assessment of pain by the patient: VAS ≥ 5.
    -Clinical symptomatology of pain lasting 3 months or more and refractory to usual analgesic treatments.
    -Written informed consent of patients.
    -Mayores de 18 años.
    -Con cicatriz dolorosa hipertrófica o queloide
    -Valoración del dolor por el paciente: EVA ≥ 5.
    -Sintomatología clínica de dolor durante 3 meses o más de duración y refractaria a los tratamientos analgésicos habituales.
    -Consentimiento informado por escrito de los pacientes.
    E.4Principal exclusion criteria
    -Previous infiltration with botulinum toxin in the 3 months prior to the begining of the study
    -Patients with uncontrolled psychiatric illnesses or dementias
    -Patients with serious systemic diseases and active infection
    -Patients in whom the use of botulinum toxin is contraindicated according to the fact sheet.
    -Pregnant or lactating patients.
    -Infiltración previa con toxina botulínica en los 3 meses previos al inicio del estudio
    -Pacientes con enfermedades psiquiátricas o demencias no controladas
    -Pacientes con enfermedades sistémicas graves e infección activa
    -Pacientes en los que esté contraindicado el uso de toxina botulínica según la ficha técnica.
    -Pacientes embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Pain: Variation in the VAS scale (0-10) at 8 weeks of treatment.
    Dolor: Variación en la escala EVA (0-10) a las 8 semanas del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 8 weeks of treatment.
    a las 8 semanas del tratamiento.
    E.5.2Secondary end point(s)
    -Effect at other different times from drug infiltration: at 4 weeks and 6 months (telephone call in both cases), to assess the maintenance of the treatment effect.
    -Vancouver Scars Scale (VSS), which contains the following 4 components:
    a) Melanin pigmentation (0-3 points),
    b) scar height (0-3 points),
    c) vascularization (0-3 points) and
    d) flexibility (0-5 points),
    -with a maximum score of 14 points indicating the greatest severity of the scar
    -Consumption of analgesics for which a diary will be provided to collect the usual analgesic medication.
    -Assess the safety and tolerability of treatment.
    -Efecto a otros tiempos diferentes desde infiltración de los medicamentos: a las 4 semanas y a los 6 meses (llamada telefónica en ambos casos), para valorar el mantenimiento del efecto del tratamiento.
    -Vancouver Scars Scale (VSS), que contiene los siguientes 4 componentes:
    a) Pigmentación de melanina (0-3 puntos),
    b) altura de la cicatriz (0-3 puntos),
    c) vascularización (0-3 puntos) y
    d) flexibilidad (0-5 puntos),
    -con una puntuación máxima de 14 puntos que indican la mayor gravedad de la cicatriz
    -Consumo de analgésicos para lo cual se facilitará un diario para recogida de medicación analgésica habitual.
    -Valorar la seguridad y tolerabilidad del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 4 weeks and 6 months
    a las 4 semanas y a los 6 meses
    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 No
    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 No
    E.8.1.1Randomised No
    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 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.8.3 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 concerned2
    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
    LVLS
    ultima visita ultimo 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 months
    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 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 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)
    None
    Ninguno
    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 Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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