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    Summary
    EudraCT Number:2013-000092-33
    Sponsor's Protocol Code Number:PDTA02_24.05.2013
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-09-19
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-000092-33
    A.3Full title of the trial
    Enhanced efficacy of photodynamic therapy in combination with 5% imiquimod -a randomised, prospective, observer-blinded study in patients with non melanoma skin cancer
    Erhöhte Wirksamkeit der photodynamischen Therapie durch Kombination mit 5% Imiquimod?- eine randomisierte, prospektive Studie in Patienten mit nicht melanozytären Hauttumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PDT versus PDT in combination with 5% Imiquimod in patients with non melanoma skin cancer
    PDT versus PDT in Kombination mit 5% Imiquimod bei Patienten mit nicht melanozytärem Hautkrebs
    A.3.2Name or abbreviated title of the trial where available
    PDT vs. PDT and 5% Imiquimod in patients with NMSC
    PDT vs. PDT und 5% Imiquimod bei Patienten mit NMSC
    A.4.1Sponsor's protocol code numberPDTA02_24.05.2013
    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 SponsorMedizinische Universität Wien, Univ.Klinik.f.Dermatologie
    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 supportMedizinische Universität Wien, Univ. Klinik für Dermatologie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Univ Klinik für Dermatologie
    B.5.2Functional name of contact pointUniv. Klinik für Dermatologie
    B.5.3 Address:
    B.5.3.1Street AddressWaehringergürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404007702
    B.5.6E-mailsonja.radakovic@meduniwien.ac.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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-Aminolevilinic Acid
    D.3.2Product code 5-ALA
    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 INN5-Aminolevulinic acid
    D.3.9.1CAS number 106-60-5
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE
    D.3.9.4EV Substance CodeSUB22645
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Aldara
    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 nameAldara
    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.3.9.3Other descriptive nameAldara
    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 number5
    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
    non melanoma skin cancer
    nicht melanozytäre Hauttumore
    E.1.1.1Medical condition in easily understood language
    superficial skin cancer
    oberflächlicher Hautkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10004146
    E.1.2Term Basal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of photodynamic therapy in combination with 5% Imiquimod versus photodynamic monotherapy in patients with non melanoma skin cancer
    Der Vergleich der Effektivität einer photodynamischen Monotherapie versus einer photodynamischen Therapie in Kombination mit 5% Imiquimod bei Patienten mit nicht-melanozytären Hauttumoren
    E.2.2Secondary objectives of the trial
    To compare the tolerability, relapse rate, patients' satisfaction, cosmetic result and the clinical response rates after treatment with photodynamic monotherapy versus photodynamic therapy in combination with 5%Imiquimod
    Vergleich der Effektivität, Rezidivrate und des kosmetischen Ergebnisses einer photodynamischen Monotherapie versus einer photodynamischen Therapie in Kombination mit 5% Imiquimod bei Patienten mit nicht-melanozytären Hauttumoren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with clinically confirmed non melanoma skin cancer elswhere on the body
    Age 18 years or older
    Patienten mit nicht melanozytären Hauttumoren
    Patienten über 18 Jahre
    E.4Principal exclusion criteria
    known allergy to imiquimod and aminolevulinic acid
    patients who are participating in another study
    patients with instable organ function
    pregnant or lactating women
    patients unable to stick to the study protocoll
    patients with severe compromised general state
    Patients with porphyria or taking photosensitizing drugs
    Porphyrie oder Einnahme von photosensibilisierenden Medikamenten
    Unverträglichkeit von Imiquimod oder Aminolävulinsäure
    schwere Beeinträchtigung des Allgemeinzudtandes
    Patienten die an einer anderen Studie teilnehmen
    Unvermögen, den Behandlungsplan zu bewältigen bzw den Pflichten des Studienteilnehmers nachzukommen
    schwangere und stillende Frauen
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of non-melanoma skin tumors cleared 3 months after completion of treatment in both groups
    Prozentsatz von abgeheilten nicht-melanozytären Hauttumoren 3 Monate nach Beendigung der Therapie in beiden Gruppen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical control after 3, 6 and 12 months after treatment with PDT or PDT mono or in combination with Imiquimod
    klinische Kontrollen 3, 6 sowie 12 Monate nach durchgeführter MonoPDT oder PDT in Kombination mit Imiquimod
    E.5.2Secondary end point(s)
    The recurrence rate of non-melanoma skin cancer at 6 and 12 months after completion of therapy in both treatment groups.
    Cosmetic response and global patients satisfaction.
    Die Rezidivrate von nicht melanozytären Hauttumoren nach 6 und 12 monaten nach Beendigung der Therapie in beiden behandelten Gruppen.
    Kosmetisches Ergebnis und Patientenzufriedenheit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Recurrence rate 6 and 12 months after completion of therapy in both treatment groups
    cosmetic response and global patients' satisfaction 3, 6, and 12 months after completion of therapy in both treatment groups
    Rezidivrate von nicht melanozytären Hauttumoren 6 und 12 Monate nach Beendigung der Therapie in beiden behandelten Gruppen.
    kosmetische Beurteilung sowie globale Patientenzufriedenheit 3, 6 und 12 Monaten nach Beendigung der Therapie in beiden Gruppen
    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 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 Yes
    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 trial2
    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.8.4.1Number 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 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
    end of the trial after completion of the follow up examination 12 month after therapy of 40 participants
    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 months24
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 88
    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 state118
    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)
    treatment after completion of the study will be according to current standard of care for this 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 Decision2013-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-26
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