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    Summary
    EudraCT Number:2013-005546-11
    Sponsor's Protocol Code Number:191213
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005546-11
    A.3Full title of the trial
    Characterisation of maximum actinic keratosis (AK) lesions count during treatment (Lmax) by non-invasive study with high definition optical coherence tomography (HD-OCT) and reflectance confocal microscopy (RCM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Characterisation of count of actinic keratosis during treatment with zyclara by non-invasive study with high definition optical coherence tomography (HD-OCT) and reflectance confocal microscopy (RCM)
    A.4.1Sponsor's protocol code number191213
    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 SponsorDEPARTMENT OF DERMATOLOGY, UNIVERSITY OF MODENA AND REGGIO EMILIA
    B.1.3.4CountryItaly
    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 ag
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITY OF MODENA AND REGGIO EMILIA, DEPARTMENT OF DERMATOLOGY
    B.5.2Functional name of contact pointSEGRETERIA DERMATOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA DEL POZZO 71
    B.5.3.2Town/ cityMODENA
    B.5.3.3Post code41143
    B.5.3.4CountryItaly
    B.5.4Telephone number00390594224265
    B.5.5Fax number00390594224271
    B.5.6E-mailsegdermo@unimore.it
    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 cream
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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)
    Cutaneous use
    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.3.9.3Other descriptive name1H-Imidazo[4,5-c]quinolin-4-amine, 1-(2-methylpropyl)-
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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
    E.1.1.1Medical condition in easily understood language
    actinic keratosis
    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 17.0
    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
    In vivo characterization of the effect of Imiquimod 3.75% in the field of cancerisation of Actinic Keratosis by HD-OCT and RCM.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible, a patient must comply with all of the following 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.
    E.4Principal exclusion criteria
    A patient is ineligible and must not enter the study if any of the following criteria is met:
    Safety concerns:
    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.

    Lack of suitability for the study:
    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 randomisation.
    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.

    Administrative reasons:
    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.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the capability of cellular-architectural resolution imaging to detect subclinical lesions and treatment reaction (Lmax) in Imiquimod 3,75% treatment field
    E.5.1.1Timepoint(s) of evaluation of this end point
    Main objective is to detect subclinical lesions and to characterize their cellular substrate before the treatment (W0) and during the treatment with Imiquimod 3.75% (at W2, W4, W6) and after 8 weeks after end of treatment
    E.5.2Secondary end point(s)
    to assess the overall treatment effect with zyclara (on visible and non-visible lesions) at a microscopic quasi histologic level.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main objective is to detect subclinical lesions and to characterize their cellular substrate before the treatment (W0) and during the treatment with Imiquimod 3.75% (at W2, W4, W6) and after 8 weeks after end of treatment
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    characterization of cellular substrates of actinic keratosis and perilesional field in the field of cancerisation before and after treatment with zyclara cream through non invasive diagnostic techniques (reflectance confocal microscopy and optical coherence tomography)
    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 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 Yes
    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 months11
    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 months11
    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.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    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)
    all patients will undergo routine skin cancer screening following the current guidelines for patients of equal age and general condition
    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 Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-14
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