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    Summary
    EudraCT Number:2020-003316-27
    Sponsor's Protocol Code Number:12020
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-003316-27
    A.3Full title of the trial
    Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream
    Behanlung Aktinischer Keratosen mit Imiquimod 3,75% Créme im frühestmöglichen Stadium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream
    Behanlung Aktinischer Keratosen mit Imiquimod 3,75% Créme im frühestmöglichen Stadium
    A.3.2Name or abbreviated title of the trial where available
    Actinic Keratosis with Imiquimod 3.75% Cream
    Aktinische Keratosen Imiquimod
    A.4.1Sponsor's protocol code number12020
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    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 supportMedical University of Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointProf. Dr. Daisy Kopera
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 8
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316385 81817
    B.5.5Fax number0043316385 81817
    B.5.6E-maildaisy.kopera@medunigraz.at
    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% cream sachets
    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 3.75% cream
    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 INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.2Current sponsor code12020
    D.3.9.3Other descriptive nameZyklara 3,75% Creme Sachets
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37,5
    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) 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
    Actintic keratosis
    Aktinische Keratosen
    E.1.1.1Medical condition in easily understood language
    Actinic Keratosis
    Aktinische Keratosen
    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 20.0
    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
    The primary endpoint of the study is to demonstrate that AK are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation also already subclinical AK can proliferate into the dermis, it is possible that on chron. light-exposed skin with the application of Imiquimod undetected PE-Ca s can be recognized and treated at the same time).
    Der primäre Studienendpunkt ist darzustellen, dass AK schon vor ihrer klinischen Sichtbarkeit vorhanden sind, eben in einem subklinischen Stadium. Da anhand der Forschungslage auch schon subklinische AK in die Dermis proliferieren können, ist es möglich, dass auf chron. lichtexponierter Haut mit der Anwendung von Imiquimod unentdeckte PE-Ca s erkannt und gleichzeitig behandelt werden können.)
    E.2.2Secondary objectives of the trial
    Quantification of subclinical damage present due to UV exposure by graduating the severity of the immunomodulatory-induced inflammatory response.
    Quantifizierung der subklinischen durch UV-Exposition vorhandenen Schädigung durch Graduierung des Schweregrads der immunmodulatorisch induzierten Entzündungsreaktion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female healthy volunteer outpatients, age: > 50 years.
    - Diagnosis: patients* with chronically uv-exposed photodamaged facial skin.
    - Consent by signing the ICF
    • männliche und weibliche ambulante gesunde freiwillige Patient*innen, Alter: > 50 Jahre
    • Diagnose: Patient*innen mit chronisch uv-exponierter lichtgeschädigter Gesichtshaut.
    • Einwilligung durch Unterschrift am ICF
    E.4Principal exclusion criteria
    - Current participation in another clinical trial
    - Patients who are using topical glucocorticoids on the face.
    - Known intolerance/hypersensitivity to imiquimod
    - Pregnant/breastfeeding women
    - Systemic disease, immunodeficiency
    • gleichzeitige Teilnahme an einer anderen klinischen Prüfung
    • Patient*innen, die im Gesicht topische Glukokortikoide anwenden
    • bekannte Unverträglichkeit/Überempfindlichkeit gegenüber Imiquimod
    • Schwangere/stillende Frauen
    • Systemerkrankung, Immundefizienz
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.
    Prozentsatz der ProbandInnen, beim dem auf chronisch lichtexponierter, uv-geschädigter Gesichtshaut eine immunmodulatorisch induzierte Entzündungsreaktion nach zwei Wochen auftritt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks
    2 Wochen
    E.5.2Secondary end point(s)
    Quantity of immunomodulatory-induced inflammatory response assessed according to 4-level scale (none, discrete, moderate, strong).
    Quantität der immunmodulatorisch induzierten Entzündungsreaktion beurteilt nach 4 stufiger Skala (keine, diskrete, moderte, starke).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 Wochen
    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 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 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.8.2.4Number of treatment arms in the trial1
    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
    LPLV
    LPLV
    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 months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state50
    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)
    Standard treatment
    Standard Therapie
    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 Decision2021-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-11
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