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    Summary
    EudraCT Number:2010-022861-93
    Sponsor's Protocol Code Number:201003.2.45
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-10-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-022861-93
    A.3Full title of the trial
    Confirmation de l'efficacité et de la tolérance du LBC 45 dans la dermite séborrhéique du cuir chevelu
    A.4.1Sponsor's protocol code number201003.2.45
    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 SponsorLaboratoire LABCATAL
    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 Yes
    D.2.1.1.1Trade name Lithioderm 8 % gel
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire LABCATAL
    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.3.1Product nameLBC 45
    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.3.9.1CAS number 60816-70-8
    D.3.9.3Other descriptive nameLITHIUM GLUCONATE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Sebiprox 1,5% shampooing
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires STIEFEL
    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 nameCiclopirox olamine 1,5%
    D.3.4Pharmaceutical form Shampoo
    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 INNCiclopirox olamine
    D.3.9.1CAS number 41621-49-2
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dermite séborrhéique du cuir chevelu
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039788
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l'efficacité du LBC 45 versus placebo dans la dermite séborrhéique du cuir chevelu d'intensité modérée à sévère, après 8 semaines de traitement.
    E.2.2Secondary objectives of the trial
    - Evaluer l'efficacité du LBC 45 versus ciclopirox olamine dans la dermite séborrhéique du cuir chevelu d'intensité modérée à sévère, après 4 et 8 semaines de traitement.
    - Evaluer l'efficacité du LBC 45 versus placebo dans la dermite séborrhéique du cuir chevelu d'intensité modérée à sévère, après 4 semaines de traitement.
    - Evaluer la tolérance locale et générale du LBC 45, après 4 et 8 semaines de traitement.
    - Comparer l'efficacité des différentes modalités d'application du LBC 45 après 4 et 8 semaines de traitement.
    - Evaluer l'acceptabilité par le patient du LBC 45 et de la ciclopirox olamine après 8 semaines de traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients des 2 sexes d’âge supérieur à 18 ans,
    - Patients ayant une dermite séborrhéique du cuir chevelu non traitée, stable ou en poussée, d’intensité modérée à sévère, correspondant à un score d’érythème ≥ 3 et un score de desquamation ≥ 3,
    - Patients ayant une dermite séborrhéique du cuir chevelu depuis au moins 2 mois,
    - Patients ayant un phototype de I à IV sur l’échelle de Fitzpatrick,
    - Patients acceptant d’arrêter l’application de tout produit topique (médicaments et/ou cosmétiques) sur le cuir chevelu, depuis au moins 2 semaines pour les cosmétiques et au moins 4 semaines pour les médicaments, avant la visite d’inclusion,
    - Pour les femmes en âge de procréer :
    - elles doivent avoir un test urinaire de grossesse négatif à l'inclusion,
    - elles doivent utiliser une méthode de contraception efficace (implant contraceptif, contraception orale, stérilet, ligature des trompes ou préservatifs) depuis au moins 2 mois avant la visite d’inclusion, pendant toute la durée de l’étude et pendant 1 mois après la fin de l’étude.
    E.4Principal exclusion criteria
    - Dermite Séborrhéique du visage traitée ou nécessitant un traitement,
    - Toutes autres dermatoses du visage ou du cuir chevelu, qu’elles soient traitées ou non,
    - Toutes pathologies nécessitant un traitement par corticoïdes (oral, injectable ou inhalé) dans les 4 semaines précédant la visite d’inclusion,
    - Antécédents d’immunodépression ou immunodépression en cours,
    - Antécédents de maladie, opérations chirurgicales ou affections psychiatriques majeures qui, d’après l’investigateur, pourrait interférer avec le produit étudié, son métabolisme et/ou le déroulement de l’étude et/ou l’évaluation des paramètres de l’étude.
    - Antécédents d’allergie à au moins un ingrédient des produits testés,
    - Traitement topique du cuir chevelu avec les produits suivants : antifongiques, corticostéroïdes, rétinoïdes, cyclines ou dérivés, triméthoprime/sulfaméthoxazole, métronidazole, traitements au lithium, shampoings à base de sélénium ou de zinc pyrithione dans les 2 semaines avant la visite d’inclusion,
    - Utilisation par voie générale d’antifongiques, de corticostéroïdes, de rétinoïdes, de cyclines ou de dérivés, de triméthoprime/sulfaméthoxazole, de métronidazole, dimmunosuppresseurs, de traitements au lithium ou de neuroleptiques dans les 4 semaines précédant la visite d’inclusion,
    - Peau sensible aux produits topiques ou cosmétiques,
    - Antécédents d’abus d’alcool ou de drogues,
    - Femmes enceintes, allaitant, n’utilisant pas de contraception, ou prévoyant une grossesse.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal est la somme des scores (SSC) de l'érythème et de la desquamation de la dermite séborrhéique au Jour 56.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    Précisé dans le protocole.
    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 months0
    E.8.9.1In the Member State concerned days70
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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 Decision2010-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-28
    P. End of Trial
    P.End of Trial StatusOngoing
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