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    Summary
    EudraCT Number:2006-003369-14
    Sponsor's Protocol Code Number:V00034CR3091B
    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:2012-03-29
    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 number2006-003369-14
    A.3Full title of the trial
    Efficacy and tolerance of the emollient cream V0034 CR in the symptomatic treatment of ichthyosis in children. International, multicentric, randomised, controlled, double blind study, in parallel groups V0034 CR versus vehicle.
    ESTUDIO SOBRE LA EFICACIA Y LA TOLERABILIDAD DE LA CREMA EMOLIENTE V0034 CR EN EL TRATAMIENTO SINTOMÁTICO DE LA ICTIOSIS EN PACIENTES PEDIÁTRICOS". ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, CONTROLADO, DOBLE CIEGO Y DE GRUPOS PARALELOS V0034 CR VERSUS EXCIPIENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and tolerance of the emollient cream V0034 CR in the symptomatic treatment of ichthyosis in children. International, multicentric, randomised, controlled, double blind study, in parallel groups V0034 CR versus vehicle.
    ESTUDIO SOBRE LA EFICACIA Y LA TOLERABILIDAD DE LA CREMA EMOLIENTE V0034 CR EN EL TRATAMIENTO SINTOMÁTICO DE LA ICTIOSIS EN PACIENTES PEDIÁTRICOS". ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, CONTROLADO, DOBLE CIEGO Y DE GRUPOS PARALELOS V0034 CR VERSUS EXCIPIENTE
    A.4.1Sponsor's protocol code numberV00034CR3091B
    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 SponsorPIERRE FABRE MEDICAMENT
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointElisabeth COPPEL
    B.5.3 Address:
    B.5.3.1Street Address3, rue Ariane
    B.5.3.2Town/ cityRAMONVILLE
    B.5.3.3Post code31527
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 5 61 73 73 24
    B.5.5Fax number+33 5 61 73 73 20
    B.5.6E-mailelisabeth.coppel@pierre-fabre.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 DEXERYL
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 V0034CR
    D.3.4Pharmaceutical form Cream
    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 INNGlycerol
    D.3.9.1CAS number 56-81-5
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPetrolatum
    D.3.9.1CAS number 8009-03-8
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLiquid paraffin
    D.3.9.1CAS number 8012-95-1
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Patients presenting with ichthyosis
    Pacientes con ictiosis
    E.1.1.1Medical condition in easily understood language
    Hereditary cutaneous disease with very dry, rough skin peeling.
    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 PT
    E.1.2Classification code 10021198
    E.1.2Term Ichthyosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of a 4 weeks treatment by the emollient V0034CR in reducing the disease severity assessed by a specified symptom sum score (SRRC) system on both legs.
    Demostrar la eficacia de un tratamiento de 4 semanas con el emoliente V0034CR en la reducción de la gravedad de la enfermedad evaluada mediante un sistema específico de puntuación total de los síntomas (SRRC) en ambas piernas.
    E.2.2Secondary objectives of the trial
    To document the maintenance of the efficacy after 12 weeks of treatment
    To evaluate the global judgement by the investigator
    To evaluate if the product is pleasant to use by the parents and/or the patient
    To document the clinical, local and systemic, safety over 12 weeks.
    Documentar la persistencia de la eficacia tras 12 semanas de tratamiento
    Evaluar la valoración global del investigador
    Evaluar si los padres o el paciente creen que el producto es agradable de utilizar
    Documentar la seguridad clínica, local y sistémica en 12 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient presenting with the following criteria may be included:
    - under 18 year-old male or female ambulatory patient,
    - suffering from an ichthyosis, excepted bullous forms of the disease, with symmetric lesions,
    - having a SRRC score sup. or equal to 4 on both external face of the legs,
    - with scaling sup. or equal to 2 (on the SRRC score) on both external face of the legs,
    - willing and able to understand and sign an approved Informed Consent Form, and/or whose parent(s) or guardian(s) has(have) given his/her(their) written consent for their child's participation in the study,
    - able to understand the protocol and to attend the control visits, and/or whose parent(s) or guardian(s) is(are) cooperative with regard to compliance with study-related constraints.
    - if required by national regulations, registered with a social security or health insurance system.
    Podrá incluirse a los pacientes que cumplan los criterios siguientes:
    - pacientes de ambos sexos menores de 18 años y ambulatorios,
    - aquejados de ictiosis, exceptuando las formas ampollares de la enfermedad, con lesiones simétricas,
    - con una puntuación SRRC >o =4 en las caras externas de las piernas,
    - con descamación >o = 2 (en la puntuación SRRC) en ambas caras externas de las piernas,
    - capaces de comprender y dispuestos a firmar el formulario de Consentimiento Informado aprobado, y/o cuyos padres o tutores hayan facilitado su Consentimiento Informado para la participación del niño o niña en el estudio,
    - capaces de comprender el protocolo y asistir a las visitas de control, y/o cuyos padres o tutores cooperen en relación con el cumplimiento de las restricciones relacionadas con el estudio.
    - si lo requiere la normativa nacional, inscritos en la Seguridad Social o una aseguradora sanitaria.
    E.4Principal exclusion criteria
    Patients presenting with any of the following criteria will not be included:

    * Criteria related to pathologies·
    - Severe forms of ichthyosis requiring an hospitalisation,·
    - Dermatological disease other than ichthyosis liable to interfere with the assessment,·
    - History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.

    * Criteria related to treatments·
    - History of allergy or intolerance to the study drug or its excipients, or to cosmetics,·
    - Treatment by systemic retinoids started or modified during the last 2 months,·
    - Homeopathic treatment during the last 2 months,
    - Treatment by local retinoids, topical or systemic corticosteroids (injectable, oral), tazarotene, calcipotriol during the last month,
    - Treatment by keratinolytics such as urea, propylene glycol, polyethylene glycol, salicylic acid, alphahydroxy acids, N-acetylcysteine during the last week,
    - Treatment by UV-B therapy during the last week,·
    - Treatment by UV-A therapy.

    * Criteria related to the way of life·
    - Use of food supplements able to modify skin (vitamin A ?) during the study duration,·
    - Practice of swimming pool, sauna, hammam, spa, UV during the study,·
    - Immoderate use of alcohol or tobacco.

    * Criteria related to the population·
    - Parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or to give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing, or patient linguistically or psychologically unable to understand the information given or formulate his/her informed consent or who refuses to give his/her consent in writing,
    - Parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship or patient subject to an administrative or court order or subject to guardianship or wardship,·
    - Parent(s) or guardian(s) who cannot be contacted by telephone in an emergency, or patient who cannot be contacted by telephone in an emergency,
    - Participation to another clinical trial in the previous month or during the study.

    For girls:
    - known pregnancy or breast feeding.
    No se incluirá a los pacientes que cumplan cualquiera de los siguientes criterios:

    * Criterios relacionados con patologías
    ?Formas graves de ictiosis que requieran hospitalización,
    ?Enfermedad dermatológica distinta de la ictiosis que pueda interferir con la evaluación,
    ?Antecedentes de enfermedad grave que el investigador considere que constituye un riesgo para el paciente o que sea incompatible con el estudio.

    * Criterios relacionados con los tratamientos
    ?Antecedentes de alergia o intolerancia al fármaco del estudio o sus excipientes, o a los productos cosméticos,
    ?Tratamiento con retinoides sistémicos iniciado o modificado durante los 2 últimos meses,
    ?Tratamiento homeopático durante los 2 últimos meses,
    ?Tratamiento con retinoides locales, corticoesteroides tópicos o sistémicos (inyectables, orales), tazaroteno, calcipotriol durante el último mes,
    ?Tratamiento con queratolíticos como urea, propilenglicol, polietilenglicol, ácido salicílico, alfa-hidroxi-ácidos, N-acetilcisteína durante la última semana,
    ?Tratamiento UV-B durante la última semana,
    ?Tratamiento UV-A.

    * Criterios relacionados con el estilo de vida
    ?Uso de complementos alimentarios que puedan modificar la piel (vitamina A, etc.) durante el estudio,
    ?Uso de piscinas, saunas, baños turcos, balnearios, rayos UV durante el estudio,
    ?Abuso del alcohol o el tabaco.

    * Criterios relacionados con la población
    ?Padres o tutores lingüística o psicológicamente incapaces de comprender la información facilitada o de dar su consentimiento informado o que rehúsen hacerlo por escrito, o pacientes lingüística o psicológicamente incapaces de comprender la información facilitada o de formular su consentimiento informado o que rehúsen hacerlo por escrito,
    ?Padres o tutores sujetos a un dictamen administrativo o judicial o sujetos a tutela, o pacientes sujetos a un dictamen administrativo o judicial o sujetos a tutela,
    ?Padres o tutores con los cuales no pueda contactarse por teléfono en caso de emergencia, o pacientes con los cuales no pueda contactarse por teléfono en caso de emergencia,
    ?Participación en otro ensayo clínico en el mes anterior o durante el estudio.


    Para las chicas:
    - embarazo conocido o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients having a 50% reduction of the SRRC score (Scaling, Roughness, Redness, Cracks fissures) between D1 and D28 on the external face of the legs (mean of the 2 legs).
    Porcentaje de pacientes con una reducción del 50% de la puntuación SRRC (siglas correspondientes a Descamación, Aspereza, Eritema, Grietas y fisuras) entre D1 y D28 en la cara externa de las piernas (media de las 2 piernas).
    E.5.1.1Timepoint(s) of evaluation of this end point
    D14, D28
    E.5.2Secondary end point(s)
    - Evolution of the SRRC score (Scaling, Roughness, Redness, Cracks fissures) from baseline to D14 and D28 on the external face on the legs (mean of the 2 legs).
    - Percentage of patients having a 50% reduction of the SRRC score from baseline to D14 on the external face of the legs (mean of the 2 legs).
    - Evolution of pruritus (V.A.S) from baseline to D14 and D28 on the whole body.
    - Evolution of the SRRC score after D28 (D56 and D84) on the external face of the legs (mean of the 2 legs).
    - Evolution of pruritus (V.A.S) after D28 (D56 and D84) on the whole body.
    - Global assessment of treatment efficacy by the investigator (D28 and D84).
    - Global assessment by the patient and/or the parents recorded by the investigator (D28, D84).
    - Assessment of the local tolerability (examination of the skin) and the systemic safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    D14, D28 (double-blind)
    D56, D84 (open-label)
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Morocco
    Russian Federation
    Tunisia
    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
    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 months9
    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 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 Yes
    F.1.1Number of subjects for this age range: 270
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 25
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 162
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Newborn - infant - toddler - children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 270
    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)
    Not applicable
    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 Decision2007-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-11-01
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