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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-003390-26
    Sponsor's Protocol Code Number:BSG-12
    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:2012-11-29
    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 number2012-003390-26
    A.3Full title of the trial
    Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Wound Healing of Split-Thickness Skin Graft Donor Sites
    Ensayo clínico multicéntrico de fase III abierto, prospectivo, controlado y aleatorizado, con evaluación enmascarada, para comparar intraindividualmente la eficacia y tolerabilidad de Oleogel- S10 con las del tratamiento de referencia para acelerar la cicatrización de la zona donante en injertos de piel de espesor parcial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Unblinded Designed, Evaluated by Blinded Experts, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare within each single patient the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Healing of Split-Thickness Skin Graft Donor Sites
    Ensayo clínico multicéntrico de fase III, de diseño abierto para investigador y paciente, evaluado por expertos en la materia ciegos al tratamiento, prospectivo, controlado y aleatorizado, para comparar en un mismo paciente la eficacia y tolerabilidad de Oleogel-S10 frente al tratamiento de referencia para acelerar la cicatrización en de la zona donante en injertos de piel de espesor parcial
    A.3.2Name or abbreviated title of the trial where available
    Oleogel-S10 in Split-Thickness Skin Graft Donor Sites
    Oleogel-S10 en zonas donantes en injertos de piel de espesor parcial
    A.4.1Sponsor's protocol code numberBSG-12
    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 SponsorBirken AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBirken AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBirken AG
    B.5.2Functional name of contact pointBusiness Unit Pharma
    B.5.3 Address:
    B.5.3.1Street AddressAm Hautpbahnhof 10
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60329
    B.5.3.4CountryGermany
    B.5.4Telephone number004972339749115
    B.5.5Fax number00496990020617
    B.5.6E-mailk.schuth@birken.eu
    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 nameOleogel-S10
    D.3.4Pharmaceutical form Ointment
    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 INNDry extract from Betulae cortex (Birch cork) (5 - 10:1), quantification: 72 to 88 % Betulin, extraction solvent: n-Heptane 95 % m/m
    D.3.9.2Current sponsor codeTE
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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) 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 Yes
    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
    Split-Thickness Skin Graft Donor Sites
    zonas donantes en injertos de piel de espesor parcial
    E.1.1.1Medical condition in easily understood language
    Wounds resulting from skin areas from which the upper skin layers have been removed in order to be used as skin transplant to cover injuries from the same patient
    Heridas en la piel que resultan de la extracción de las capas superiores de la piel con el fin de trasnplantarlas en el propio paciente para cubrir otras lesiones.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041667
    E.1.2Term Split thickness skin graft
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare intra-individually the efficacy and tolerance of Oleogel-S10 versus standard of care non-adhesive wound dressing alone in accelerating the wound healing of Split-Thickness Skin Graft Donor Sites.
    Comparación intraindividual de la eficacia y la tolerancia de Oleogel-S10 frente al tratamiento habitual, tratamiento solo con apósitos no adhesivos, para la aceleración de la cicatrización de las zonas de extracción de injertos de piel de espesor parcial.
    E.2.2Secondary objectives of the trial
    not applicable
    no aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients at least 18 years old who have provided written informed consent
    Presenting a split-thickness skin graft donor site wound with a minimum size of 20 cm2 and with a minimum width of 3 cm.
    Patient is able to understand the ICF provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing change and photo documentation every second to third day until both wound halves are closed (but no longer than 28 days after surgery).
    Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits.
    Women of childbearing potential who are in the period between menarche and menopause must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)). Birth control method must have been applied for at least 1 monthly cycle prior to first administration of study drug, be maintained during the study treatment phase and continued for at least 30 days after the last administration of study drug. Sexually active, non-vasectomized men must use a barrier method (condoms) during the treatment phase of this clinical trial.
    Pacientes iguales o mayores de 18 años que han proporcionado su consentimiento informado por escrito.
    Herida en la zona de extracción del injerto de piel de espesor parcial de un tamaño mínimo de 20 cm2 y una anchura mínima de 3 cm.
    El paciente es capaz de entender el formulario de consentimiento informado proporcionado y está dispuesto a cumplir todos los requisitos del ensayo clínico, incluyendo lo siguiente: Visita al centro del ensayo para el cambio del apósito y la documentación fotográfica cada dos o tres días hasta el cierre de las dos mitades de la herida (pero no más de 28 días desde la intervención quirúrgica).
    Disposición a realizar todos los cambios de apósito necesarios en el centro del ensayo. El paciente también debe aceptar volver al centro para las visitas de seguimiento a los tres y a los doce meses.
    Las mujeres en edad fértil, aquellas que se encuentran en el período comprendido entre la menarquia y la menopausia deben aplicar un método de alta eficacia en el control de la natalidad (tasa de fracaso inferior al 1% por año cuando se usan sistemática y correctamente (por ejemplo, implantes, inyectables, anticonceptivos orales combinados, algunos dispositivos anticonceptivos intrauterinos (DIU), la abstinencia sexual, o un socio vasectomizado)). El método de control de natalidad deberá haberse aplicado durante al menos 1 ciclo mensual antes de la primera administración del fármaco del estudio, se mantendra durante la fase de tratamiento del estudio y continuará durante al menos 30 días después de la última administración del fármaco del estudio. Los hombres sexualmente activos, no vasectomizados, deben usar un método de barrera (condones) durante la fase de tratamiento de este ensayo clínico.
    E.4Principal exclusion criteria
    Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy.
    A skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
    A history of clinically significant hypersensitivity to any of the drugs, surgical dressings or excipients to be used in this trial.
    Known multiple allergic disorders.
    Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
    Pregnant or breast feeding women are not allowed to participate in the study.
    Inappropriate to participate in the study, for any reason, in the opinion of the investigator.
    Mental incapacity or language barriers precluding adequate understanding the Informed consent form or co-operation or willingness to follow study procedures.
    Previous participation in this study.
    Employee at the investigational site, relative or spouse of the investigator.
    Enfermedades o trastornos que, en opinión del investigador, podrían interferir en la evaluación de la seguridad o la eficacia.
    Una enfermedad cutánea crónica o actualmente activa que el investigador considere que afectará de forma negativa a la cicatrización de las heridas o que afecte a las zonas que se deben examinar en este ensayo.
    Antecedentes de hipersensibilidad clínicamente significativa a cualquiera de los fármacos, apósitos quirúrgicos o excipientes que se utilizarán en este ensayo.
    Trastornos alérgicos múltiples conocidos.
    La toma actual o haber tomado fármacos en fase de investigación durante los tres meses previos a la visita de selección.
    Las mujeres embarazadas o o en periodo de lactancia no podrán participaren el ensayo clínico.
    El paciente no es adecuado para participar en el ensayo clínico por cualquier motivo, según el criterio del investigador.
    Incapacidad mental o barreras idiomáticas que impiden la adecuada comprensión del formulario de consentimiento informado o la cooperación o disposición necesarias para cumplir los procedimientos del ensayo clínico.
    Haber participado anteriormente en este ensayo clínico.
    Ser empleado del centro de investigación, familiar o esposa del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Intra-individual difference in time to wound closure (at least 95% epithelialisation) between wound halves either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone (standard of care), based on blinded photo evaluation by three independent, blinded experts.
    Diferencia intraindividual del tiempo hasta el cierre de la herida (epitelización de al menos un 95%) entre las mitades de una herida, una de ellas tratada con Oleogel-S10 y un apósito no adhesivo y la otra tratada únicamente con un apósito no adhesivo, tratamiento habitual, basada en una evaluación enmascarada de fotografías por parte de tres expertos independientes que no conocen la medicación administrada. .
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every wound dressing change (at least every second or third day until full wound closure is achieved; no longer than 28 days after surgery)
    En cada cambio de apósito (por lo menos cada dos o tres días hasta que la herida esté completamente cerrada, no más de 28 días después de la cirugía)
    E.5.2Secondary end point(s)
    A) Intra-individual difference in time to wound closure (at least 95% epithelialisation) between wound halves either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone, separately for each of the three independent, blinded experts.
    B) Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing alone.
    C) Percentage of patients with earlier healing of wound area treated with Oleogel-S10 compared to non-adhesive wound dressing alone.
    D) Percentage of patients with wound closure at different time points.
    E) Percentage of wound epithelialization at different time points as assessed by the Investigator.
    F) Assessment of efficacy (evaluated by both the investigators and patients).
    G) Cosmetic outcome after 3 and 12 months after surgery with regard to texture, redness, growth of hair, and pigmentation, based on blinded photo evaluation.
    H) Assessment of tolerance (evaluated by both the investigators and patients).
    I) PK data: Systemic presence/concentration of betulin in blood plasma samples.
    J) Assessment of adverse events.
    A) Diferencia intraindividual del tiempo hasta el cierre de la herida (epitelización de al menos un 95%) entre las mitades de una herida, una de ellas tratada con Oleogel-S10 y un apósito no adhesivo y la otra tratada únicamente con un apósito no adhesivo, de forma separada para cada uno de los tres expertos independientes que no conocen la medicación administrada.
    B) Tiempo desde la intervención quirúrgica hasta el cierre de la herida de forma separada para la mitad de la herida tratada con Oleogel-S10 y un apósito no adhesivo frente a la mitad tratada únicamente con un apósito no adhesivo.
    C) Porcentaje de pacientes con una cicatrización más temprana de la zona de la herida tratada con Oleogel-S10 que la tratada únicamente con un apósito no adhesivo
    D) Porcentaje de pacientes con cierre de la herida en diferentes momentos.
    E) Porcentaje de epitelización de la herida en diferentes momentos según la evaluación del investigador
    F) Evaluación de la eficacia (efectuada por los investigadores y los pacientes)
    G) Resultado estético después de tres y doce meses tras la intervención con respecto a la textura, el enrojecimiento, el crecimiento de pelo y la pigmentación según una evaluación enmascarada de fotografías
    H) Evaluación de la tolerancia (efectuada por los investigadores y los pacientes)
    I) Datos FC: Presencia/concentración sistémica de betulina en muestras de plasma sanguíneo
    J) Evaluación de acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    A) to E), J):
    At every wound dressing change (at least every second or third day until full wound closure is achieved; no longer than 28 days after surgery)

    F):
    Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before

    G):
    3 and 12 months after surgery

    H):
    Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before

    I):
    Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before
    de A) a la E), J):

    En cada cambio de apósito (por lo menos cada dos o tres días hasta que la herida esté completamente cerrada, no más de 28 días después de la cirugía)

    F):

    Días 7,14,21,28 (cada +/ - 1 día); solo si la herida no se ha cerrado antes.

    G):

    3 y 12 meses después de la cirugía

    H): Días 7,14,21,28 (cada +/ - 1 día); solo si la herida no se ha cerrado antes.

    I): Días 7,14,21,28 (cada +/ - 1 día); solo si la herida no se ha cerrado antes.
    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 Yes
    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 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
    Abierto Comparación intraindividual basada en fotoevaluaciónciega por 3 expertos ciegos e independ.
    Open Intra-individual comparison based on blinded photoevaluation by 3 independent blinded experts
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cura de la herida tratada solamente con cualquier tipo de apósito noadhesivo(práctica clín Habitual)
    Wound treatment with any kind of non-adhesive wound dressing only (standard of care)
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    LPLV
    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 months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months17
    E.8.9.2In all countries concerned by the trial days0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    If the patient completes the clinical trial as expected his/her split-thickness skin graft donor site are completly epithelialized. In these cases no further treatment is required.
    Upon early discontinuation of the trial for whatever reason, patients will be
    treated according to individual needs at the discretion of the
    Investigator.
    Si el paciente finaliza el ensayo clínico, según lo esperado, su zona donante en injertos de piel de espesor parcial estará totalmente epitelizado. En estos casos no se requerirá ningún otro tratamiento.
    En caso de abandono prematuro del ensayo clínico por cualquier razón, los pacientes serán tratados según sus necesidades individuales y a criterio del investigador.
    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 Decision2013-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-23
    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
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