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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:2017-004451-24
    Sponsor's Protocol Code Number:HC-ENS-2017-01
    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:2017-11-17
    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 number2017-004451-24
    A.3Full title of the trial
    Phase IV, unicentric, open-label, randomized clinical trial to evaluate clinic and non-invasive response to clobetasol cream versus betamethasone dipropionate and calcipotriol foam treatments in plaque psoriasis.
    Ensayo clínico fase IV, unicéntrico, abierto, aleatorizado sobre la evaluación clínica y microscópica no invasiva de la respuesta al tratamiento con clobetasol en crema versus dipropionato de betametasona y calcipotriol en espuma, en la psoriasis en placa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study compares clinically and microscopically the response to two treatments, a steroid in cream and a foam that contains a steroid and a vitamin D analogue in patients with plaque psoriasis.
    Estudio que compara clínica y microscópicamente la respuesta a dos tratamientos, un esteroide en crema y una espuma que contiene un esteroide y un análogo de la vitamina D en pacientes con psoriasis en placa.
    A.4.1Sponsor's protocol code numberHC-ENS-2017-01
    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 SponsorFundació Clínic per a la Reserca Biomèdica
    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 supportLEO Pharma, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrialance
    B.5.2Functional name of contact pointCristina Sacristán
    B.5.3 Address:
    B.5.3.1Street Addressc/ Riera de Tena, 38-40
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08014
    B.5.3.4CountrySpain
    B.5.6E-mailcsacristan@trialance.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 Enstilar
    D.2.1.1.2Name of the Marketing Authorisation holderLEo Pharma, S.A.
    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 Cutaneous foam
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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.IMP: 2
    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.2.1.1.1Trade name Clovate
    D.2.1.1.2Name of the Marketing Authorisation holderINDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
    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 Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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
    Plaque psoriasis
    Psoriasis en placa
    E.1.1.1Medical condition in easily understood language
    Psoriais with thickened and white plaques
    Psoriasis en forma de placas engrosadas y blaquecinas
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 is to define the relationship that exists between the clinical and microscopic evaluation in a target lesion (changes produced at the tissue and cell level) and the secondary effects evaluated microscopically in the psoriatic plaque after the treatment with clobetasol cream only and with Calcipotriol / Betamethasone dipropionate in foam as the only treatment.
    El objetivo principal es definir la relación que existe entre la evaluación clínica y microscópica en una lesión diana (cambios producidos a nivel tisular y celular) y los efectos secundarios evaluados microscópicamente en la placa psoriásica después del tratamiento con clobetasol crema únicamente y con Calcipotriol/Betamethasone en espuma como único tratamiento.
    E.2.2Secondary objectives of the trial
    Clinical and microscopic evaluation of the recurrence of the disease after clearance in the different treatment arms of the study.
    Evaluation of the safety and tolerability of the different treatments of the study.
    Evaluation of the level of patient satisfaction with the treatment received in the study.
    Evaluación clínica y microscópica de la recurrencia de la enfermedad después del aclaramiento en los diferentes brazos de tratamiento del estudio.
    Evaluación de la seguridad y tolerabilidad de los distintos tratamientos del estudio.
    Evaluación del nivel de satisfacción del paciente con el tratamiento recibido en el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who agree to participate in the study and sign the informed consent (IC).
    Patients diagnosed clinically and / or histologically from plaque psoriasis.
    Men or women ≥ 18 years.
    Patients willing to comply with the requirements of the protocol and with the capacity to do so.
    Outpatient patients
    Patients who are candidates for treatment with any of the study medications.
    Pacientes que acepten participar en el estudio y firmen el consentimiento informado (CI).
    Pacientes diagnosticados clínicamente y/o histológicamente de psoriasis en placa.
    Hombres o mujeres ≥ 18 años.
    Pacientes dispuestos a cumplir con las exigencias del protocolo y con capacidad para hacerlo.
    Pacientes ambulatorios.
    Pacientes candidatos a recibir tratamiento con cualquiera de los medicamentos del estudio.
    E.4Principal exclusion criteria
    Hypersensitivity to any of the active principles or any of the excipients that appear listed in the technical data sheet of the study drugs.
    Erythrodermic, exfoliative or pustular psoriasis.
    Patients with known disorders in calcium metabolism.
    Acute renal failure.
    Acute liver disorders.
    Facial or genital psoriasis.
    Patients with viral skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, atrophic streaks, fragility of skin veins, ichthyosis, acne vulgaris, acne Rosacea, rosacea, ulcers and wounds.
    Systemic treatment including cyclosporin A, methotrexate and steroids in the last 4 weeks.
    Patients who have received systemic treatment with biological therapies, commercialized or not, with possible effect on plaque psoriasis during the following periods:
    - etanercept: 4 weeks before visit 1 (week 0)
    - adalimumab, alefacept, infliximab: 2 months before visit 1 (week 0)
    - ustekinumab; 4 months prior to visit 1 (week 0)
    - experimental products: 4 weeks or 5 half-lives (whichever is longer) prior to visit 1 (week 0)
    Patients who have received topical treatment in the last 15 days.
    Patients who have received treatment with phototherapy during the following periods:
    - PUVA: 4 weeks before visit 1 (week 0)
    - UV-B: 2 weeks before visit 1 (week 0)
    History of concomitant serious systemic inflammatory cutaneous diseases.
    Pregnant or lactating women
    Patients who have participated in another clinical study in the 30 days prior to randomization.
    Hipersensibilidad a cualquiera de los principios activos o cualquiera de los excipientes que aparecen listados en la ficha técnica de los medicamentos del estudio.
    Psoriasis eritrodérmica, exfoliativa o pustulosa.
    Pacientes con trastornos conocidos en el metabolismo del calcio.
    Insuficiencia renal aguda.
    Desórdenes hepáticos agudos.
    Psoriasis facial o genital.
    Pacientes con lesión viral de la piel, infecciones cutáneas fúngicas o bacterianas, infecciones parasitarias, manifestación en la piel en relación con la tuberculosis, dermatitis perioral, piel atrófica, estrías atróficas, fragilidad de las venas de la piel, ictiosis, acné vulgar, acné rosácea, rosácea, úlceras y heridas.
    Tratamiento sistémico incluyendo ciclosporina A, metotrexato y esteroides en las últimas 4 semanas.
    Pacientes que hayan recibido tratamiento sistémico con terapias biológicas, comercializadas o no, con posible efecto sobre la psoriasis en placa durante los siguientes periodos:
    - etanercept: 4 semanas previas a visita 1 (semana 0)
    - adalimumab, alefacept, infliximab: 2 meses previos a visita 1 (semana 0)
    - ustekinumab; 4 meses previos a visita 1 (semana 0)
    - productos experimentales: 4 semanas o 5 vidas medias (lo que sea más largo) previas a la visita 1 (semana 0)
    Pacientes que hayan recibido tratamiento tópico en los últimos 15 días.
    Pacientes que hayan recibido tratamiento con fototerapia durante los siguientes periodos:
    - PUVA: 4 semanas previas a visita 1 (semana 0)
    - UV-B: 2 semanas previas a visita 1 (semana 0)
    Historia de enfermedades cutáneas inflamatorias sistémicas graves concomitantes.
    Mujeres embarazadas o lactantes.
    Pacientes que hayan participado en otro estudio clínico en los 30 días previos a la randomización.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the clinical response and microscopic changes of the key identifiers for plaque psoriasis in the different treatment arms (Cal / BD and clobetasol) in adult patients affected by plaque psoriasis and treated for a period of up to 4 weeks.
    Comparación de la respuesta clínica y los cambios microscópicos de los indentificadores clave para la psoriasis en placa en los diferentes brazos de tratamiento (Cal/BD y clobetasol) en pacientes adultos afectados por psoriasis en placa y tratados por un periodo de hasta 4 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study (from visit 1 to visit 5)
    A lo largo del estudio (visita 1 a visita 5)
    E.5.2Secondary end point(s)
    Evaluate and compare the significant clinical and microscopic changes detectable related to side effects during treatment in the 2 arms of the study.
    To assess and compare the timing and clinical and microscopic characteristics of the recurrence of plaque psoriasis after treatment in the 2 arms of the study.
    Evaluate the degree of patient satisfaction with the medication after treatment in both arms of the study
    Evaluar y comparar los cambios clínicos y microscópicos significativos detectables relacionados con efectos secundarios durante el tratamiento en los 2 brazos del estudio.
    Evaluar y comparar el momento y las características clínicas y microscópicas de la recurrencia de la psoriasis en placa después del tratamiento en los 2 brazos del estudio.
    Evaluar el grado de satisfacción del paciente con el medicamento después del tratamiento en los dos brazos del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study (from visit 1 to visit 5)
    A lo largo del estudio (visita 1 a visita 5)
    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.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 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 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) Yes
    E.8.2.2Placebo No
    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
    The clinical trial will end when the last included patient has completed the follow-up visit (visit 5). In case of patients who leave the study prematurely due to recurrence of plaque psoriasis, an attempt will be made to follow up the resolution. In the case of patients who leave the study voluntarily, it will not be possible to follow up.
    El ensayo clínico finalizará cuando el último paciente incluido haya completado la visita de seguimiento (visita 5). En caso de pacientes que abandonen el estudio de forma prematura debido a recurrencia de la psoriasis en placa, se intentará hacer un seguimiento hasta la resolución. En el caso de los pacientes que abandonan el estudio de forma voluntaria, no será posible realizar el seguimiento.
    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
    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: 36
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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)
    At the end of the study, patients will receive the treatment that their doctor considers most appropriate.
    Al finalizar el estudio los pacientes recibirán el tratamiento que su médico considere más adecuado.
    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 Decision2018-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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