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    Summary
    EudraCT Number:2014-003691-23
    Sponsor's Protocol Code Number:50621
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-30
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003691-23
    A.3Full title of the trial
    Topical Ingenol mebutate versus 5% 5-fluorouracil versus 5% Imiquimod versus photodynamic therapy in the treatment of actinic keratosis: a multi-center randomized efficacy and cost-effectiveness study
    Topicaal ingenol mebutate versus 5% 5-fluorouracil versus 5% imiquimod versus fotodynamische therapie in de behandeling van aktinische keratose: een multi-center gerandomiseerde effectiviteit en kosten effectiviteit studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative study for the treatment of actinic keratosis: 5% fluorouracil versus Imiquimod versus photodynamic therapy versus ingenol mebutate.
    Vergelijkende studie naar de behandeling van aktinische keratose: 5% fluorouracil versus Imiquimod versus photodynamic therapy versus ingenol mebutate.
    A.4.1Sponsor's protocol code number50621
    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 SponsorMaastricht Universitair Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointShima Ahmady
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 AZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailshima.ahmady@mumc.nl
    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 Ingenol mebutate (Picato)
    D.2.1.1.2Name of the Marketing Authorisation holderLEO pharma (Picato)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Cream
    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.IMP: 2
    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 5% Imiquimod (Aldara)
    D.2.1.1.2Name of the Marketing Authorisation holderMeda
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameAldara
    D.3.2Product code EU/1/98/080/001-002
    D.3.4Pharmaceutical form Cream
    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.IMP: 3
    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 5% 5-fluorouracil (efudix)
    D.2.1.1.2Name of the Marketing Authorisation holderMeda
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 name5% 5-fluorouracil
    D.3.2Product code PL 15142/0003
    D.3.4Pharmaceutical form Cream
    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.IMP: 4
    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 Methylaminolevulinic acid (Metvix)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMethylaminolevulinic acid
    D.3.2Product code PL 10590/0048
    D.3.4Pharmaceutical form Cream
    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
    Actinic keratosis
    aktinische keratose
    E.1.1.1Medical condition in easily understood language
    solar keratosis
    aktinische keratose
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary outcome measure: treatment success (i.e. the proportion of patients with ≥75% lesion reduction in the number of AK lesions counted at baseline in the treatment area) 12 months post treatment
    Primaire uitkomstmaat: behandelsucces (i.e. de proportie patiënten met ≥75% laesie reductie in het aantal AK laesies geteld op moment van inclusie) 12 maanden na behandeling.
    E.2.2Secondary objectives of the trial
    - Partial response (proportion of participants at 12 months post treatment with 50-75% reduction in number of AK lesions)
    - Treatment failure (proportion of participants at 12 months post treatment with <50% reduction in number of AK lesions)
    - Complete lesion clearance (proportion of lesions with 100% clearance in all treated patients per study arm)
    - Partial lesion clearance (proportion of lesions with ≥75% clearance in all treated patients per study arm)
    - Decrease in number AK from baseline per patient
    - Number of SCC’s developing in the treatment area, during study follow-up, and long-term follow-up.
    - Healthcare/treatment costs
    - Side effects
    - Patient satisfaction
    - Cosmetic outcome
    - Treatment compliance
    - Partiële response (proportie van patiënten op 12 maanden na behandeling met 50-75% reductie in het aantal AK laesies)
    - Behandel falen (proportie part at 12 maanden na behandeling met <50% reductie in aantal AK laesies)
    - Complete laesie clearance (proportie of laesies met 100% clearance in alle behandelde patienten per studie arm)
    - Partiële laesie clearance (proportie laesies met ≥75% clearance in alle behandelde patienten per studie arm)
    - Afname in aantal AK vanaf baseline per patient
    - Aantal PCC's die ontwikkelen in het behandelde gebied tijdens studie follow-up en long-term follow-up
    - Gezondheidszorg/behandel kosten
    - Bijwerkingen
    - Patiënt tevredenheid
    - Cosmetische outcome
    - Behandel compliance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 18 years
    - Female in child bearing potential should be using contraceptive measures,
    during and till 3 months post-treatment
    - Fitzpatrick skintype I-IV
    - Clinically confirmed diagnosis of AK
    - One joint area of minimal 25 cm2 and maximal 100 cm2 of AK
    - AK Olsen grade I-III
    - Location: head/neck area
    - Patiënten ouder dan 18 jaar
    - Vrouwelijke patiënten in vruchtbare leeftijd moeten anticonceptive
    maatregelen gebruiken gedurende en tot 3 maanden na behandeling
    - Fitzpatrick huidtype I-IV
    - Klinische diagnose AK
    - Een aaneengesloten gebied van minimaal 25 cm2 en maximaal 100 cm2
    - AK Olsen graad I-III
    - Locatie: hoofd/hals gebied
    E.4Principal exclusion criteria
    - Received any kind of treatment for AK in the past 3 months
    - (N)MSC in target area
    - Immuno-comprised status
    - Use of immunosuppressant drugs in the past 3 months and / or at time of
    treatment (inhalation corticosteroids / nasal corticosteroids are permitted)
    - Porphyria
    - Not able to give informed consent
    - Allergy to study drugs or nut/soy products
    - Pregnant and breastfeeding women
    - Genetic skin cancer disorders
    - No understanding of dutch language
    - Patienten die enige behandeling voor AK hebben gehad de afgelopen 3 maanden
    - (N)MSC in te behandelen gebied
    - Immuungecompromitteerde status
    - Gebruik van immuunsupressiva in de afgelopen 3 maanden en/of ten tijde
    van behandeling (inhalatie corticosteroiden of nasale corticosteroiden zijn
    toegestaan)
    - Porphyrie
    - Niet in staat om informed consent te geven
    - Allergie voor studie medicatie of noten/soja producte
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: treatment success (i.e. the proportion of patients with ≥75% lesion reduction in the number of AK lesions counted at baseline in the treatment area) 12 months post treatment
    Primaire uitkomstmaat: behandelsucces (i.e. de proportie patiënten met ≥75% laesie reductie in het aantal AK laesies geteld op moment van inclusie) 12 maanden na behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months post-treatment
    12 maanden na behandeling
    E.5.2Secondary end point(s)
    - Partial response (proportion of participants at 12 months post treatment with 50-75% reduction in number of AK lesions)
    - Treatment failure (proportion of participants at 12 months post treatment with <50% reduction in number of AK lesions)
    - Complete lesion clearance (proportion of lesions with 100% clearance in all treated patients per study arm)
    - Partial lesion clearance (proportion of lesions with ≥75% clearance in all treated patients per study arm)
    - Decrease in number AK from baseline per patient
    - Number of SCC’s developing in the treatment area during study follow-up, and long-term follow-up.
    - Healthcare/treatment costs
    - Side effects
    - Patient satisfaction
    - Cosmetic outcome
    - Treatment compliance
    - Partiële response (proportie van patiënten op 12 maanden na behandeling met 50-75% reductie in het aantal AK laesies)
    - Behandelfalen (proportie van patiënten op 12 maanden na behandeling met <50% reductie in aantal AK laesies)
    - Complete laesie clearance (proportie of laesies met 100% clearance in alle behandelde patienten per studie arm)
    - Partiële laesie clearance (proportie laesies met ≥75% clearance in alle behandelde patiënten per studie arm)
    - Afname in aantal AK vanaf baseline per patient
    - Aantal PCC's die ontwikkelen in het behandelde gebied, tijdens studie follow-up en long-term follow-up
    - Gezondheidszorg/behandelkosten
    - Bijwerkingen
    - Patiënttevredenheid
    - Cosmetische outcome
    - Behandel compliance
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months post treatment
    The number of SCC in the treatment area 12 months post treatment and long-term (2- to 5-years) post study treatment
    12 maanden na behandeling
    Aantal SCC tijdens studiebehandeling, 12 maanden na behandeling en tijdens long-term follow-up (2 tot 5 jaar na einde studiebehandeling)
    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 Yes
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    End of the trial is defined as the date on which 624 individuals are included in the study
    Het einde van de trial is gedefinieerd als de dag waarop 624 patienten geincludeerd zijn in het onderzoek
    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 months36
    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: 312
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 312
    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 state624
    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)
    Regular follow-up due to standard care
    Reguliere follow-up volgens standaard zorg.
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-01
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