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    Summary
    EudraCT Number:2013-004037-32
    Sponsor's Protocol Code Number:Lmax-microscopy-Bcn
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-004037-32
    A.3Full title of the trial
    Characterisation of maximum lesion count during treatment (Lmax) by non-invasive study with high definition optical coherence tomography (HD-OCT) and reflectance confocal microscopy (RCM)
    Caracterización del número máximo de lesiones durante el tratamiento (Lmax) mediante estudio no invasivo con tomografía de coherencia óptica de alta definición (HD-OCT) y microscopía confocal de reflectancia (RCM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of two diagnostic tools in lesion count during treatment
    Estudio de dos técnicas diagnósticas para el recuento de lesiones durante el tratamiento
    A.3.2Name or abbreviated title of the trial where available
    Lmax assessed by HD-OCT and RCM
    A.4.1Sponsor's protocol code numberLmax-microscopy-Bcn
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    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 supportMeda Pharma
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL CLINIC BARCELONA
    B.5.2Functional name of contact pointDERMATOLOGY DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street AddressVILLARROEL 170
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932275400
    B.5.6E-mailJMALVEHY@CLINIC.UB.ES
    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 ZYCLARA 3,75% crema
    D.2.1.1.2Name of the Marketing Authorisation holderMeda Pharma
    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 namezyclara
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    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
    actinic keratosis
    Queratosis actínica
    E.1.1.1Medical condition in easily understood language
    actinic keratosis
    Queratosis actínica
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    5in vivo comparison of effect of imiquimod 3.75% in detection of subclinical lesions of actinic keratosis using high definition optical coherence tomography (HD-OCT) and Reflectance confocal microscopy (RCM).
    Comparación in vivo del efecto de imiquimod 3.75% en la detección de lesiones subclínicas de queratosis actínica con el uso de tomografía de coherencia óptica de alta definición (HD-OCT) y microscopía confocal de reflectancia (RCM).
    E.2.2Secondary objectives of the trial
    clinical classification os all lesion observed
    clinical evaluation of actinic keratosis
    adverse events
    clasificación clínica de todas las áreas predefinidas
    evaluación clínica de la queratosis actínica
    acontecimientos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Immunocompetent Caucasian patient.
    2. 5-20 clinically evident AK lesions either on full face or balding scalp.
    3. Male
    or
    female without child-bearing potential.
    4. Having at least 1 AK and 1 subclinical lesion in the study area diagnosed by HD-OCT or RCM.
    5. Willingness to have reflectance confocal microscopy examination and HD-OCT examination performed in treatment area
    1) Pacientes inmunocompetente de raza caucásica.
    2) Con 5-20 lesiones de queratosis actínica (QA) clínicamente evidentes ya sea en la cara o el cuero cabelludo alopécico.
    3) Hombres, o mujeres sin posibilidades de embarazo .
    4) Tener al menos una lesión clínica y una lesión subclínica de QA en el área estudiada, diagnosticadas mediante HD-OCT o RCM.
    5) Disposición a ser explorados mediante la tomografía de coherencia óptica de alta definición (HD-OCT) y microscopía confocal de reflectancia (RCM) en el área del tratamiento
    E.4Principal exclusion criteria
    1. Contraindications for imiquimod treatment: Hypersensitivity to imiquimod or to any of the excipients (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum).
    2. Broken skin in the study treatment area.
    3. Autoimmune condition.
    4. Severe haematological disease
    5. Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns.
    6. Treatment of AKs in region of eyes, lips or nostrils
    7. Any kind of AK treatment at the STA within the last 2 months prior to patient inclusion.
    8. Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen?s disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
    9. Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
    10. History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study.
    11. Mentally incapacitated patient.
    12. Present or history of drug or alcohol abuse within the last 3 years.
    13. Exposure to an investigational product within the last 3 months.
    14. Lack of ability or willingness to give informed consent.
    15. Age below 18 years.
    16. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
    17. Anticipated non-availability for study visits/procedures.
    18. Vulnerable subjects (such as persons kept in detention)
    19. The planned sample size has been reached.
    1) Contraindicaciones para el tratamiento con imiquimod: Hipersensibilidad al imiquimod o a cualquiera de sus excipientes.
    2) Discontinuidades de la piel en el área de tratamiento del estudio.
    3) Enfermedad autoinmune.
    4) Enfermedad hematológica grave.
    5) Presencia de lesiones de queratosis actínica en el área del estudio con hiperqueratosis clínicamente excesiva como en los cuernos cutáneos.
    6) Tratamiento de QA en la región ocular, labios o narinas
    7) Cualquier tipo de tratamiento de la queratosis actínica en el área del estudio en los últimos 2 meses antes de la inclusión en el estudio.
    8) Presencia de cualquier tumor de piel histológicamente confirmado en el área del estudio: carcimona celular escamoso in situ incluyendo la enfermedad de Bowen, carcinoma celular escamoso invasivo, carcinoma de células basales u otros tumores malignos.
    9) Tratamiento inmunomodulador sistémico como el interferón, azatioprina, ciclosporina, retinoides, corticosteroides orales o inyectables, corticosteroides inhalados o nasales con dosis de> 1.200 µg/ día de beclometasona o equivalente en las 4 semanas antes del inicio del tratamiento del estudio.
    10) Historia de enfermedad graves cardiovascular, pulmonar, hepática, renal, gastrointestinal, hematológica, endocrina, metabólica, trastornos mentales, neurológicos u otra enfermedad en los últimos dos años que pudiera dificultar el tratamiento regular y la supervisión del paciente y pudiera provocar la retirada prematura del estudio.
    11) Pacientes incapacitados mentalmente.
    12) Historia actual o antecedentes de abuso de drogas o alcohol en los últimos 3 años.
    13) La exposición a un producto en investigación en los últimos 3 meses.
    14) La falta de capacidad o voluntad de dar el consentimiento informado.
    15) Edad menor a 18 años.
    16) La falta de voluntad de proporcionar los datos personales recogidos relacionados con el estudio.
    17) Previsión de falta de disponibilidad para acudir a las visitas / seguir los procedimientos del estudio.
    18) Los sujetos vulnerables (población cautiva como las personas detenidas o encarceladas).
    19) Cuando se ha alcanzado el tamaño de la muestra previsto.
    E.5 End points
    E.5.1Primary end point(s)
    Number of subclinical lesions previously determined (at W0) by non invasive methods by RCM and /or HD-OCT that become clinically visible and clear during treatment with IMIQ 3.75% at week 14.
    Número de lesiones subclínicas determinadas previamente (en la semana 0) por métodos no invasivos (tomografía de coherencia óptica de alta definición (HD-OCT) y microscopía confocal de reflectancia (RCM)) que se hacen clínicamente visibles durante el tratamiento con imiquimod al 3,75% y que desaparecen en la semana 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 14
    semana 14.
    E.5.2Secondary end point(s)
    b) Clinical classification in all areas at any visit of the predefined diagnostic areas for type of AK lesions. The study area will be evaluated for the presence and number of: 1. Non-affected; 2. Subclinical AK; 3. Clinical visible AK. (schematics with a grid will be used to asses the presence and localisation of AK , new AK, subclinical AK and inflammation on clinical naked-eye examination ).
    c) OCT/RCM evaluation of clinically apparent AK at W6 and W14 and additionally at W2 and W4 on decision of investigator (for inflammatory reactions)
    d) Number of countable new AK lesions at every evaluation up to Week 14
    e) Number of subclinical lesions turning visible under therapy and cleared at W14.
    f) Adverse events in the study treatment area and in predefined diagnostic areas.
    1. Clasificación clínica en todas las áreas predefinidas del tipo de lesiones de queratosis actínica (QA) en cualquier visita. En el área de estudio se evaluará la presencia y el número de las lesiones como: 1. Área no afectada; 2. QA Subclínica, 3.QA Clínicamente visible.

    2. Evaluación clínica de la queratosis actínica (QA) aparente con OCT/RCM en S6 y S14, y adicionalmente, en S2 y S4 a criterio del investigador (para reacciones inflamatorias).

    3. Número de nuevas lesiones de queratosis actínica contables en cada evaluación hasta la semana 14.

    4. Número de lesiones subclínicas que se hacen visibles durante el tratamiento y que desaparecen en la semana14.

    5. Los eventos adversos en el área de tratamiento del estudio y en las áreas del diagnóstico predefinidas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    weeks 2,4,6 and 14
    semanas 2, 4, 6 y 14
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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.8.5The 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
    LVLS
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    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 state20
    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 Decision2014-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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