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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2017-004608-22
    Sponsor's Protocol Code Number:17-PP-21
    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:2018-02-27
    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 number2017-004608-22
    A.3Full title of the trial
    Open, prospective, single-center study evaluating the efficacy and safety of 0.05% ingénol mebutate (Picato® 500) in the treatment of basal cell carcinoma
    Study "PICABAS"
    Etude ouverte, prospective, monocentrique, évaluant l'efficacité et la tolérance du mébutate d'ingénol 0,05% (Picato® 500) dans le traitement du carcinome baso-cellulaire
    Etude « PICABAS »
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open, prospective, single-center study evaluating the efficacy and safety of 0.05% ingénol mebutate (Picato® 500) in the treatment of basal cell carcinoma
    Study "PICABAS"
    Etude ouverte, prospective, monocentrique, évaluant l'efficacité et la tolérance du mébutate d'ingénol 0,05% (Picato® 500) dans le traitement du carcinome baso-cellulaire
    Etude « PICABAS »
    A.3.2Name or abbreviated title of the trial where available
    Study "PICABAS"
    Study "PICABAS"
    A.4.1Sponsor's protocol code number17-PP-21
    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 SponsorCHU de Nice
    B.1.3.4CountryFrance
    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 supportCHU de NICE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone number04 92 03 40 11+33
    B.5.6E-maildrc@chu-nice.fr
    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 Picato 500 microgrammes de mébutate d'ingénol
    D.2.1.1.2Name of the Marketing Authorisation holderPicato 500 µg/g
    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 namePicato 500µg/g
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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
    Patients with one or more basal cell carcinoma superficial, or nodular, trunk or limb
    Patients ayant un ou plusieurs CBC superficiel, ou nodulaire, du tronc ou des membres (cuir chevelu et visage exclus), confirmé histologiquement par biopsie
    E.1.1.1Medical condition in easily understood language
    Patients with one or more carcinoma
    Patients avec un ou plusieurs carcinomes
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007284
    E.1.2Term Carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimate the efficiency, in terms of complete remission ( RC), 1 or 2 cycles (for the patients not having answered the first cycle) of a topical treatment(processing) by the MIDDLE OF 500 µg / g at patients presenting a superficial squamous-cell carcinoma ( CBCs) or nodulaire ( CBCn) of the trunk and the members
    Evaluer l’efficacité, en termes de rémission complète (RC), d’1 ou 2 cycles (pour les patients n’ayant pas répondu au premier cycle) d’un traitement topique par MI 500 µg/g chez des patients présentant un carcinome baso-cellulaire superficiel (CBCs) ou nodulaire (CBCn) du tronc et des membres.
    E.2.2Secondary objectives of the trial
    1. To determine the tolerance of the treatment
    2. To estimate the tumoral answer according to the clinical criteria, dermoscopiques, optical coherence tomography, ultrasound, and histological
    1. De déterminer la tolérance du traitement
    2. D’évaluer la réponse tumorale en fonction des critères cliniques, dermoscopiques, Tomographie à Cohérence Optique, échographiques, et histologiques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients of both sexes of more than 18 years old
    • Patients having one or several superficial CBC, or nodulaire, of the trunk or the members (scalp and face excluded), confirmed histologically by biopsy
    • primitive CBC, of main line between 1 and 4 cms
    • Patients des deux sexes âgés de plus de 18 ans
    • Patients ayant un ou plusieurs CBC superficiel, ou nodulaire, du tronc ou des membres (cuir chevelu et visage exclus), confirmé histologiquement par biopsie
    • CBC primitif, de grand axe compris entre 1 et 4 cm
    E.4Principal exclusion criteria
    • CBC of the scalp or the face
    • CBC reoffend, sclérodermiforme, infiltrating, métatypique
    • CBC of diameter > 4cm
    • CBC situated unless 10 cms of another CBC included in the protocol
    • allergic Patient in at the MI or in an excipient of the finished product (example alcohol isopropylique) as indicated on the note of the medicine.
    • Patient treaty by immunosuppresseurs, immunomodulateurs, agents cytotoxiques by systematic way or local corticoids applied to the zone of the CBC, during 4 weeks preceding the visit of selection
    ·• cosmetic or therapeutic Treatment or any procedure which could interfere with the evaluation of the handled zone
    • Presence of a dermatological affection susceptible to interfere with the treatment(processing) or its evaluation (eczema, psoriasis, etc.)
    • Presence of néoplasie associated evolutionary other than a Melanoma of Dubreuil In situ (except squamous-cell carcinoma, carcinoma épidermoïde cutaneous, carcinoma of the in situ neck of the womb and the in situ mammary carcinoma)
    • Use of the MI, the cryotherapy, the imiquimod, Dynamic Phototherapy, or treatment by radiotherapy in the zone of treatment and 5 cms all around in 6 months preceding the first visit
    • pregnant or breast-feeding Woman (an urinary pregnancy test will be realized)
    • Infection known by the HIV
    • transplanted Patient
    • Participation or less than 30 days in a medicinal clinical trial
    • CBC du cuir chevelu ou du visage
    • CBC récidivant, sclérodermiforme, infiltrant, métatypique
    • CBC de diamètre > 4cm
    • CBC situé à moins de 10 cm d’un autre CBC inclus dans le protocole
    • Patient allergique au MI ou à un excipient du produit fini (exemple alcool isopropylique) comme indiqué sur la notice du médicament.
    • Patient traité par immunosuppresseurs, immunomodulateurs, agents cytotoxiques par voie systémique ou corticoïdes locaux appliqués sur la zone du CBC, au cours des 4 semaines précédant la visite de sélection
    • Traitement cosmétique ou thérapeutique ou toute procédure qui pourrait interférer avec l’évaluation de la zone traitée
    • Présence d’une affection dermatologique susceptible d’interférer avec le traitement ou son évaluation (eczéma, psoriasis, etc.)
    • Présence de néoplasie associée évolutive autre qu’un Mélanome de Dubreuil In situ (sauf carcinome basocellulaire, carcinome épidermoïde cutané, carcinome du col utérin in situ et carcinome mammaire in situ)
    • Utilisation de MI, de cryothérapie, d’imiquimod, Photothérapie Dynamique, ou traitement par radiothérapie dans la zone de traitement et 5 cm autour dans les 6 mois précédant la première visite
    • Femme enceinte ou allaitante (un test de grossesse urinaire sera réalisé)
    • Infection connue par le VIH
    • Patient transplanté
    • Participation en cours ou de moins de 30 jours à un essai clinique médicamenteux
    • Toute condition médicale ou psychiatrique qui pourrait empêcher la bonne compréhension et la conduite du traitement et de l’étude (majeur sous tutelle)
    E.5 End points
    E.5.1Primary end point(s)
    The main assessment criterion is the complete, clinical and histological remisision, of the CBC in 3 months of the end of a cycle of treatment. In case of failure of the first cycle of treatment, a second cycle will be realized and the RC will be revalued in 3 months. The RC is defined as the absence of visible lesion clinically (with examination dermoscopie) and histologically (biopsy cutaneous).
    Le critère de jugement principal est la RC, clinique et histologique, du CBC à 3 mois de la fin d’un cycle de traitement. En cas d’échec du premier cycle de traitement, un second cycle sera réalisé et la RC sera réévaluée à 3 mois. La RC est définie comme l’absence de lésion visible cliniquement (avec examen en dermoscopie) et histologiquement (biopsie[s] cutanées).
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 Days or 180 days (for patient without complete remission after 1 cycle of treatment)
    90 jours ou 180 jours (pour les patients n'ayant pas une rémission complète après le 1er cycle de traitement)
    E.5.2Secondary end point(s)
    1. The type, the frequency, the severity and the time of arisen the side effects.
    2. The clinical criteria, dermoscopiques, OCT, ultrasound, histological
    1. Le type, la fréquence, la sévérité et le délai de survenue des effets secondaires.
    2. Les critères cliniques, dermoscopiques , OCT , échographiques, histologiques
    E.5.2.1Timepoint(s) of evaluation of this end point
    90 Days or 180 days (for patient without complete remission after 1 cycle of treatment)
    90 jours ou 180 jours (pour les patients n'ayant pas une rémission complète après le 1er cycle de traitement)
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 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 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
    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 months18
    E.8.9.1In the Member State concerned days
    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: 26
    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 No
    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 state28
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 28
    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
    Non
    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 Decision2018-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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