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    Summary
    EudraCT Number:2011-001697-26
    Sponsor's Protocol Code Number:055-006
    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:2011-12-19
    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 number2011-001697-26
    A.3Full title of the trial
    Optimising outpatient care in mild to moderate psoriasis by a newly developed Topical Treatment Optimising Programme - an international study using Daivobet®/Dovobet® Gel (PSO-TOP)
    Optimización del cuidado del paciente ambulatorio con psoriasis leve a moderada con el recién creado Programa de Optimización del Tratamiento Tópico, un estudio internacional utilizando Daivobet® Gel (PSO-TOP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimising outpatient care in mild to moderate psoriasis by a newly developed Topical Treatment Optimising Programme - an international study using Daivobet®/Dovobet® Gel (PSO-TOP)
    Optimización del cuidado del paciente ambulatorio con psoriasis leve a moderada con el recién creado Programa de Optimización del Tratamiento Tópico, un estudio internacional utilizando Daivobet® Gel (PSO-TOP)
    A.3.2Name or abbreviated title of the trial where available
    PSO-TOP
    PSO-TOP
    A.4.1Sponsor's protocol code number055-006
    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 SponsorProfessor Reich
    B.1.3.4CountryGermany
    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
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCIderm GmbH
    B.5.2Functional name of contact pointInternational Project Management
    B.5.3 Address:
    B.5.3.1Street AddressEsplanade 6
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20354
    B.5.3.4CountryGermany
    B.5.4Telephone number4940554401230
    B.5.5Fax number4940554401291
    B.5.6E-mailcontact@sciderm.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 Daivobet Gel
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharmaceutical Products
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameCALCIPOTRIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26081
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBETAMETHASONE DIPROPIONATE
    D.3.9.1CAS number 5593-20-4
    D.3.9.4EV Substance CodeSUB00783MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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.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
    Mild to moderate active plaque psoriasis despite topical psoriasis treatment
    Placas de psoriasis activas leves a moderadas a pesar del tratamiento tópico para psoriasis.
    E.1.1.1Medical condition in easily understood language
    Mild to moderate active plaque psoriasis despite topical psoriasis treatment
    Placas de psoriasis activas leves a moderadas a pesar del tratamiento tópico para psoriasis.
    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 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To assess the value of the Topical Treatment Optimising Programme in the topical treatment of insufficiently treated mild to moderate psoriasis after 8 weeks of once daily treatment with Daivobet® Gel.
    Objetivo principal:
    Evaluar el valor del Programa de Optimización del Tratamiento Tópico en el tratamiento tópico de psoriasis leve a moderada insuficientemente tratada, al cabo de 8 semanas de tratamiento diario con Daivobet® Gel.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    To assess the value of the Topical Treatment Optimising Programme in the topical treatment of insufficiently treated mild to moderate psoriasis every 8 weeks over a treatment period of 64 weeks.
    To assess the usefulness of a Topical Therapy Questionnaire, a Patient Preference Questionnaire and Patient?s self Global Assessment in the assessment of patient reported outcomes and in comparison to available tools.
    To assess the value of the Topical Treatment Optimising Programme in country-specific subanalyses.
    To compare the drop-out rates after 64 weeks of treatment between the study arms (Topical Treatment Optimising Programme versus non- Topical Treatment Optimising Programme).
    To compare the consumption of Daivobet® Gel between the study arms.
    To confirm long term efficacy and safety of the study medication.
    Objetivos secundarios:
    Evaluar el valor del Programa de Optimización del Tratamiento Tópico en el tratamiento tópico de psoriasis leve a moderada insuficientemente tratada cada 8 semanas durante un periodo de tratamiento de 64 semanas.
    Evaluar la utilidad del Cuestionario de Terapia Tópica, el Cuestionario de Preferencia del Paciente y la Autoevaluación global del Paciente en la valoración de informes de los pacientes y en comparación con herramientas disponibles.
    Evaluar el valor del Programa de Optimización del Tratamiento Tópico en sub-análisis específicos de cada país.
    Comparar las tasas de abandono tras 64 semanas de tratamiento en los brazos del estudio (Programa de Optimización del Tratamiento Tópico versus sin Programa de Optimización del Tratamiento Tópico).
    Comparar el consumo de Daivobet® Gel entre los dos brazos del estudio.
    Confirmar la eficacia y seguridad de la medicación del estudio a largo plazo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients aged at least 18 years
    - Mild to moderate active plaque psoriasis with a PGA ? 2 on the 7 point scale by Langley and Ellis and a Body Surface Area (BSA) of ? 10%
    - Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol / 0.5 mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
    - Written informed consent to participate in the study has been given prior to any study related procedures
    Pacientes de ambos sexos mayores de 18 años
    - Psoriasis en placas activa con un PGA ? 2 en la escala de 7 puntos de Langley y Ellis y un Área de Superficie Corporal (BSA) de ? 10%
    - Tratamiento tópico de psoriasis con breas, tazaroteno, esteroides, o análogos de la vitamina D, o combinaciones de esteroides y análogos de la vitamina D (exceptuando productos de combinación en gel que contengan 50 microgramos de calcipotriol / 0.5 mg betametasona/g) o ditranol y sus preparados combinados durante al menos 8 semanas previas a la Visita 1 (semana 0)
    - Se ha entregado, previamente a cualquier procedimiento relacionado con el estudio, un consentimiento informado escrito para participar en el estudio
    E.4Principal exclusion criteria
    - Severe renal insufficiency
    - Severe hepatic disorders
    - Known hyper calcaemia
    - Erythrodermic, exfoliative, pustular or guttate psoriasis
    - Facial or genital psoriasis
    - Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®
    - Pregnant and/or breast-feeding women or women of childbearing potential who do not agree to use one of the following contraceptive methods for the duration of the study and at least 1 week after the last dose of the study medication: Intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
    - Hypersensitivity to the active substances or to any of the excipients
    - Suspected non-compliance with the clinical study procedures
    - Current participation in another clinical study
    - Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0):
    . etanercept ? within 4 weeks prior to Visit 1 (week 0)
    . adalimumab, alefacept, infliximab ? within 2 months prior to Visit 1 (week 0)
    . ustekinumab ? within 4 months prior to Visit 1 (week 0)
    . experimental products ? within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0)
    - Phototherapy within the following time periods prior to Visit 1 (week 0):
    . PUVA ? within 4 weeks prior to Visit 1 (week 0)
    . UV-B ? within 2 weeks prior to Visit 1 (week 0)
    - Insuficiencia renal aguda
    - Desórdenes hepáticos agudos
    - Hipercalcemia conocida
    - Psoriasis eritrodérmica, exfoliativa, pustular o gutata
    - Psoriasis facial o genital
    - Cumplir con al menos una de las contraindicaciones del Prospecto de Daivobet® Gel
    - Mujeres embarazadas y/o lactantes o mujeres en edad fértil que no utilicen alguno de los siguientes métodos anticonceptivos durante todo el estudio y al menos hasta una semana después de la última dosis de la medicación del estudio: dispositivos intrauterinos o anticonceptivos hormonales (píldoras anticonceptivas, implantes, parches transdérmicos, dispositivos hormonales vaginales o inyecciones de liberación prolongada).
    - Hipersensibilidad a los principios activos o a cualquiera de sus excipientes
    - Sospecha de que no cumpla con los procedimientos del estudio clínico
    - Actual participación en otro estudio clínico
    - Tratamiento sistémico con terapias biológicas, comercializadas o no, con posible efecto sobre la psoriasis vulgaris durante los siguientes periodos previos a la Visita 1 (semana 0):
    . etanercept ? en 4 semanas previas a la Visita 1 (semana 0)
    . adalimumab, alefacept, infliximab ?en 2 meses previos a la Visita 1 (semana 0)
    . ustekinumab ? en 4 meses previos a la Visita 1 (semana 0)
    . productos experimentales ?en 4 semanas/ 5 vidas medias (lo que sea más largo) previo a la Visita 1 (semana 0)
    - Fototerapia dentro de los siguientes periodos previos a la Visita 1 (semana 0):
    . PUVA - 4 semanas antes de la Visita 1 (semana 0)
    . UV-B - 2 semanas antes de la Visita 1 (semana 0)
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at week 8
    Tasa de pacientes con PGA (según la definición de Langley y Ellis 2004) de 0 ó 1 en la semana 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8
    semana 8
    E.5.2Secondary end point(s)
    Rate of patients with a PGA (as defined by Langley and Ellis 2004) of 0 or 1 at weeks 16 to 64 (documented at intervals of 8 weeks)

    Mean PGA and BSA at weeks 8 to 64 (documented at intervals of 8 weeks)

    EQ-5D, EQ-VAS and DLQI at weeks 0, 8, 32 and 64

    Rate of patients achieving DLQI ? 5 at weeks 0, 8, 32 and 64

    Exploratory Patient Reported Outcomes: TTQ, PPQ and PsGA at weeks 0, 8, 32 and 64

    Results of TTOP element ranking by the patient (only TTOP intervention arm) at weeks 8 and 64

    Rate of patients reaching a PsGA score of 0 or 1 at weeks 8 to 64 in the single countries (documented at intervals of 8 weeks)

    Days away from work/studies due to psoriasis

    Mean weight of returned study medication at weeks 4 to 64 (documented at intervals of 4 to 8 weeks)

    Drop-out rate per study arm at week 64

    Rates of AEs and SAEs
    Tasa de pacientes con PGA PGA (según la definición de Langley y Ellis 2004) de 0 ó 1 en las semanas 16 a 64 (documentado en intervalos de 8 semanas)
    Promedio de PGA y BSA de las semanas 8 a 64 (documentado en intervalos de 8 semanas)
    EQ-5D, EQ-VAS y DLQI en las semanas 0, 8, 32 y 64
    Tasa de pacientes que alcanzan DLQI ? 5 en las semanas 0, 8, 32 y 64
    Cuestionarios del Paciente Exploratorios: TTQ, PPQ y PsGA en las semanas 0, 8, 32 y 64
    Resultados de la puntuación de elementos del TTOP según el paciente (sólo rama con intervención de TTOP) en las semanas de 8 a 64
    Tasa de pacientes que alcanzan una puntuación de PsGA de 0 ó 1 en las semanas 8 a 64 en cada país (documentado a intervalos de 8 semanas)
    Días faltados al trabajo/estudios debido a la psoriasis
    Peso medio de la medicación del estudio devuelto en las semanas 4 a 64 (documentado a intervalos de 4 a 8 semanas)
    Tasa de abandono por brazo del estudio en la semana 64
    Tasas de AEs y SAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study from week 0 to week 64
    Durante todo el estudio desde la semana 0 hasta la semana 64
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Improvement of patient compliance
    Mejorar el cumplimiento del paciente
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Programa de Optimización del Tratamiento Tópico
    Topical Treatment Optimising Programme
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-19. Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1956
    F.4.2.2In the whole clinical trial 1956
    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)
    Animar al paciente a visitarle (o a otro dermatólogo, si procede) de forma periódica.
    Prescribir la medicación necesaria.
    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 Decision2012-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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