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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2006-004278-28
    Sponsor's Protocol Code Number:RD.03.SPR.29058
    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:2007-01-31
    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 number2006-004278-28
    A.3Full title of the trial
    Eficacia y Seguridad de la Combinación Fija de Adapaleno 0,1% / Peróxido de Benzoilo 2,5% Gel Comparada con Clindamicina 1% / Peróxido de Benzoilo 5% Gel en el Tratamiento del Acné Vulgar.
    A.4.1Sponsor's protocol code numberRD.03.SPR.29058
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGALDERMA Research & Development
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAdapalene 0.1%/Benzoyl Peroxide 2.5%
    D.3.2Product code Adapalene BPO
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADAPALENE
    D.3.9.1CAS number 106685409
    D.3.9.2Current sponsor codeCD 271
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1%
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN peroxido de benzoilo
    D.3.9.1CAS number 94360
    D.3.9.2Current sponsor codeCD 1579
    D.3.9.3Other descriptive name PEROXIDO DE BENZOILO
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5%
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Duac Gel
    D.2.1.1.2Name of the Marketing Authorisation holderStiefel, 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.3.1Product nameDuac Gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLINDAMYCIN
    D.3.9.1CAS number 18323449
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 94360
    D.3.9.3Other descriptive nameBENZOYL PEROXIDE
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5%
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Tratamiento del acné vulgaris
    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
    Demostrar que el Adapaleno 0,1% / Peróxido de Benzoilo 2,5% Gel (en adelante Adapaleno PBO) tiene una eficacia no inferior a la de Clindamicina 1% / Peróxido de Benzoilo 5% Gel (en adelante Clindamicina PBO) en el tratamiento del acné vulgar.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres o mujeres de cualquier raza, con edades comprendidas entre los 12 y los 35 años, ambos inclusive, con acné vulgar facial,
    2. Sujetos con un mínimo de 20 lesiones inflamatorias (pápulas y pústulas) en la cara,
    3. Sujetos con un mínimo de 30 y un máximo de 100 lesiones no inflamatorias (comedones abiertos y cerrados) en la cara, con exclusión de la nariz,
    4. Mujeres en edad fértil con resultado negativo en el test de embarazo en el Inicio y que utilicen algún método anticonceptivo de alta eficacia durante el estudio: anticonceptivos orales (con dosis estable durante al menos los 3 meses previos al comienzo del estudio), DIU, anticonceptivos sistémicos (inyectables o parches), abstinencia estricta o con pareja vasectomizada,
    5. Mujeres sin capacidad para procrear por alguna de las siguientes situaciones, premenstruales, posmenopáusicas (ausencia de sangrado menstrual durante 2 años), con histerectomía, ligadura bilateral de trompas, ovariectomía bilateral, infertilidad secundaria y esterilidad. Estos Sujetos no han de someterse al TE al comienzo del estudio,
    6. Los Sujetos con edad igual o superior a 18 años (16 en Reino Unido) deben leer y firmar el formulario de Consentimiento Informado previamente a su participación en el estudio. Los Sujetos menores de 18 años (16 en Reino Unido) pueden firmar un formulario de asentimiento de participación, debiendo uno de los padres (ambos en Alemania) o tutor leer y firmar el Consentimiento Informado previamente a su participación en el estudio. No es necesario la presencia de los padres o el tutor en las visitas de seguimiento, a menos que sea requerida,
    7. Sujetos con voluntad y capacidad para colaborar en el grado establecido por el protocolo.
    E.4Principal exclusion criteria
    1. Sujetos con lesiones acne-quísticas,
    2. Mujeres embarazadas, en periodo de lactancia o con intención de quedarse embarazadas durante el periodo de estudio,
    3. Sujetos con algún trastorno o que presenten una condición tal que, en opinión del Investigador, pueda poner al Sujeto en una situación de riesgo (incluyendo enfermedad de Crohn, colitis ulcerosa o colitis asociada al consumo de antibióticos), pueda alterar los resultados del estudio o pueda interferir en la adherencia del Sujeto al estudio,
    4. Sujetos con alergia conocida a alguno de los componentes de los productos a estudiar (ver el prospecto del envase y/o la información que posea el investigador),
    5. Sujetos que hayan participado en otro estudio de investigación sobre productos o dispositivos farmacéuticos en los 30 días previos al reclutamiento,
    6. Sujetos en periodo de reposo farmacológico para un tratamiento tópico en la cara, con duración inferior a
    ·Corticosteroides, antibióticos, antisépticos, retinoides, otros antiinflamatorios u antiacnéicos 2 semanas
    ·Fármacos que contengan zinc 1 semana
    ·Dispositivos de fototerapia para el acné 1 semana

    7. Sujetos en periodo de reposo farmacológico para un tratamiento sistémico, con duración inferior a (ver la tabla siguiente):
    ·Corticosteroides, antibióticos (excepto penicilinas puras) 4 semanas
    ·Otros antiacnéicos (incluyendo isotretinoína) 6 meses
    ·Acetato de ciproterona / Acetato de Clormadinona 6 meses
    ·Espironolactona / Drospirenona 3 meses
    NOTA: Se acepta vitamina A oral hasta la dosis diaria recomendada, 4000-5000 UI,

    8.Sujetos con acné conglobata, acné fulminante, acné adverso (cloracné, acné inducido por fármacos, etc.),
    9.Sujetos con barba o con un vello facial tal que pueda interferir con el seguimiento del estudio,
    10.Sujetos de riesgo en relación con las precauciones, advertencias y contraindicaciones (ver el prospecto del envase y/o la información que posea el investigador),
    11.Sujetos en los que sea previsible una exposición intensa a la radiación UV durante la realización del estudio (deportes de montaña, radiación UV, baños de sol, etc...).
    E.5 End points
    E.5.1Primary end point(s)
    Variable de la eficacia principal·
    . Variación porcentual en el número total de lesiones contabilizadas (tanto no inflamatorias como inflamatorias) en el Inicio y en la semana 12.

    Variable de seguridad·
    . Incidencia de Efectos adversos·
    . Tolerabilidad local - eritema, descamación, sequedad, escozor/quemazón
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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.8.3 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 EEA29
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    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 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 2007-01-31. 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
    Se incluiran menores en el estudio. Estos menores podran firmar una hoja de asentimiento y los padres o tutores firmaran el Consentimiento Informado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 280
    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)
    En el caso de un abandono prematuro el investigador se asegurara de que el paciente recibe la terapia apropiada y/o tratamiento de referencia. tras la conclusion del estudio, el investigador aconsejara al paciente si este lo solicita. De acuerdo con la evaluacion del estatus actual del acne por parte del investigador, podra detener el tratamiento y comenzar la terapia de mantenimiento o cambiar a otro tratamiento para acne ya comercializado
    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 Decision2007-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-01
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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