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    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-002540-13
    Sponsor's Protocol Code Number:RD.06.SPR.18252
    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:2015-10-30
    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 number2015-002540-13
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo  para comparar la eficacia y seguridad de la crema CD5789 50 µg/g frente a la crema placebo en sujetos  con acné vulgar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para comparar la eficacia y seguridad de la crema CD5789 50 µg/g frente a la crema placebo en sujetos con acné vulgar
    A.3.2Name or abbreviated title of the trial where available
    Double-Blind Efficacy and Safety of CD5789 50µg/g Cream versus Vehicle Cream in Acne Vulgaris
    A.4.1Sponsor's protocol code numberRD.06.SPR.18252
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/231/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalderma R&D SNC
    B.1.3.4CountryFrance
    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 supportGalderma R&D
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiltern International Spain S.A.
    B.5.2Functional name of contact pointRicardo Diaz (General Director)
    B.5.3 Address:
    B.5.3.1Street AddressCentro Empresarial Euronova 3, Ronda de Poniente 10 ? 2ª Planta
    B.5.3.2Town/ cityTres Cantos, Madrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491187 27 00
    B.5.5Fax number+3491187 28 49
    B.5.6E-mailspain.regulatory@chiltern.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 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.3.2Product code CD5789
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Yes
    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 INNTrifarotene
    D.3.9.1CAS number 895542-09-3
    D.3.9.2Current sponsor codeCD5789
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50.000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    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
    Acne Vulgaris
    Acné vulgar
    E.1.1.1Medical condition in easily understood language
    Acne
    Acné
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000519
    E.1.2Term Acne vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the efficacy and safety of CD5789 50µg/g cream applied once daily for 12 weeks in subjects with moderate facial and truncal acne vulgaris.
    Los objetivos del ensayo clínico son evaluar la eficacia y la seguridad de la crema CD5789 50µg/g aplicada una vez al día durante 12 semanas en sujetos con acné vulgar de leve a moderado en la cara y en el tronco.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 9 years of age and older, at the Screening visit.
    2. The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
    3. The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.
    4. The subject has truncal acne severity grade of 3 (moderate) on the Physician Global assessment (PGA) scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of study drug by the subject (optional criterion for subject between 9 and 11 years of age).
    1. El sujeto es un hombre o una mujer de 9 años en adelante en la visita de selección.
    2. El sujeto presenta acné facial con un grado de intensidad 3 (moderado) según la escala de evaluación global del investigador (Investigator Global Assessment, IGA) en la visita de selección y de inicio.
    3. El sujeto presenta un mínimo de 20 lesiones inflamatorias y 25 lesiones no inflamatorias en la cara en la visita de selección y de inicio.
    4. El sujeto presenta acné en el tronco con un grado de intensidad 3 (moderado) según la escala de evaluación global del médico (Physician Global Assessment, PGA) en las visitas de selección y de inicio en partes del tronco (hombros, parte superior de la espalda y parte superior anterior del pecho), a las que el propio sujeto pueda llegar para aplicarse el fármaco del estudio (criterio opcional para sujetos entre 9 y 11 años de edad).
    E.4Principal exclusion criteria
    1. The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
    2. The subject has more than 1 nodule on the face at Screening and Baseline.
    3. The subject has more than 1 nodule on the trunk at Screening and Baseline
    4. The subject has any acne cysts on the trunk at Screening and at Baseline.
    1. El sujeto presenta formas graves de acné (p. ej., acné conglobata, acné fulminante) o forma de acné secundaria (p. ej., cloracné, acné inducido por fármacos, etc.).
    2. El sujeto presenta más de 1 nódulo en la cara en la visita de selección y de inicio.
    3. El sujeto presenta más de 1 nódulo en el tronco en la visita de selección y de inicio.
    4. El sujeto presenta algún quiste de acné en la cara en la visita de selección y de inicio.
    E.5 End points
    E.5.1Primary end point(s)
    1) Success Rate, defined as the percentage of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement
    2) Absolute Change in facial non-inflammatory lesion count.
    3) Absolute Change in facial inflammatory lesion count
    1) Tasa de éxito, definida como el porcentaje de sujetos que alcanzaron una puntuación en la IGA de 1 (Casi remisión) o 0 (Remisión) y al menos una mejoría de 2 grados desde el inicio hasta la semana 12.
    2) Cambio absoluto en el número de lesiones no inflamatorias faciales desde el inicio hasta la semana 12.
    3) Cambio absoluto en el número de lesiones inflamatorias faciales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) from Baseline to Week 12
    2) from Baseline to Week 12
    3) from Baseline to Week 12
    1) Desde el inicio hasta la semana 12
    2) Desde el inicio hasta la semana 12
    3) Desde el inicio hasta la semana 12
    E.5.2Secondary end point(s)
    1) Percentage of subjects who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2 grade improvement
    2) Absolute change in truncal non-inflammatory lesion count
    3) Absolute change in truncal inflammatory lesion count
    1) Porcentaje de pacientes que alcanzan una puntuación PGA de 1 (casi limpio) o 0 (limpio) y una mejoría de al menos 2 grados
    2) Cambio absoluto en el recuento de lesiones no inflamatorias troncales
    3) Cambio absoluto en el recuento de lesiones inflamatorias troncales
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) from Baseline to Week 12
    2) from Baseline to Week 12
    3) from Baseline to Week 12
    1) Desde el inicio hasta la semana 12
    2) Desde el inicio hasta la semana 12
    3) Desde el inicio hasta la semana 12
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Hungary
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    United States
    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 (UVUP)
    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 months4
    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 months4
    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 Yes
    F.1.1Number of subjects for this age range: 720
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 672
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 478
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 2015-10-30. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors
    Menores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 672
    F.4.2.2In the whole clinical trial 1200
    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
    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 Decision2016-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-12
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