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    Summary
    EudraCT Number:2014-003331-18
    Sponsor's Protocol Code Number:PDTBG2
    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:2014-11-24
    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 number2014-003331-18
    A.3Full title of the trial
    The influence of occlusive application of 5-aminolaevulinic acid (ALA) on
    the efficacy of photodynamic therapy for actinic keratosis
    Einfluß der okklusiven Applikation von 5 Aminolävulinsäure (ALA) auf die
    Wirksamkeit der photodynamischen Therapie bei der Behandlung von
    aktinischen Keratosen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ALA-PDT without vs ALA-PDT in combination with occlusion in patients
    with actinic keratosis
    ALA-PDT ohne vs ALA-PDT in Kombination mit Okklusion bei
    Patienten mit aktinischen Keratosen
    A.3.2Name or abbreviated title of the trial where available
    PDT vs PDT and translucent bandage in patients with AK
    ALA-PDT ohne vs ALA-PDT in Kombination mit Okklusion bei Patienten mit
    A.4.1Sponsor's protocol code numberPDTBG2
    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 AddressWaeringer Guertel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040077020
    B.5.5Fax number+4314040076990
    B.5.6E-mailsonja.radakovic@meduniwien.ac.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 Ameluz
    D.2.1.1.2Name of the Marketing Authorisation holderBiofontera Bioscience GmbH
    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 nameAmeluz
    D.3.2Product code EMEA/H/C/002204-N/005
    D.3.4Pharmaceutical form Gel
    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 33320-16-0
    D.3.9.3Other descriptive nameMETHYL AMINOLEVULINATE
    D.3.9.4EV Substance CodeSUB22645
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number78
    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 17.1
    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
    The influence of occlusive application of 5-aminolaevulinic acid on the
    efficacy of photodynamic therapy in patients with actinic keratosis
    Einfluss der okklusiven Applikation von 5-Aminolävulinsäure auf die
    Wirksamkeit von photodynamischen Therapie bei der Behandlung von
    aktinischen Keratosen
    E.2.2Secondary objectives of the trial
    To compare the tolerability , relapse rate , local phototoxic reaction and
    cosmetic results of occlusive application of 5-aminolaevulinic acid on the
    efficacy of photodynamic therapy in patients with actinic keratosis
    Vergleich der Schmerzintensität, Rezidivrate, der phototoxischen lokalen Reaktion und des kosmetischen Ergebnisses okklusiven Applikation von 5-Aminolävulinsäure auf die Wirksamkeit von photodynamischen
    Therapie bei der Behandlung von aktinischen Keratosen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with clinically confirmed actinic keratosis in the face and scalp
    Age 18 years or older
    Patienten mit aktinischen Keratosen im Gesicht und auf der unbehaarten Kopfhaut
    Patienten über 18 Jahren
    E.4Principal exclusion criteria
    Known allergy to aminlevulinic acid
    Patients with porphyria or taking photosensitizing drugs
    Patients with severe compromised general state
    Patients who are participating in another study
    Patients unable to stick to the study protocol
    Pregnant or lactating women
    Unverträglichkeit von Aminolävilinsäure
    Porphyrie oder Einnahme von photosensibilisierenden Medikamenten
    Schwere Beeinträchtigung des Allgemeinzustandes
    Patienten die an einer anderen Studie teilnehmen
    Unvermögen, den Behandlungsplan zu bewältigen bzw. den Pflichten des
    Studienteilnehmers nachzukommen
    Schwangere und stillenede Frauen
    E.5 End points
    E.5.1Primary end point(s)
    Complete clearance of actinic keratosis 3 months after completion of
    treatment
    Komplette Abheilung der aktinischen Keratose 3 Monate nach Ende der Therapie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical control after 3 months after treatment with PDT with or without
    occlusive application
    Klinische Kontrolle 3 Monate nach durchgeführter PDT mit oder ohne
    okklusiver Applikation
    E.5.2Secondary end point(s)
    The recurrence rate of actinic keratosis at 6 months after completion of
    the therapy as well as tolerability , local phototoxic reaction and
    cosmetic response in both groups
    Die Rezidivrate von aktinischen Keratosen 6 Monaten nach Beendigung
    der Therapie sowie Schmerzintensität, lokale phototoxische Reaktion
    und kosmetische Ergebnis in beiden Gruppen
    E.5.2.1Timepoint(s) of evaluation of this end point
    The recurrence rate of actinic keratosis at 6 months after completion of therapy
    Cosmetic response 6 months after completion of therapy
    Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days
    after therapy
    Tolerability 1,5,10 minutes after the beginning as well as 10 and 30
    minutes after finishing the therapy
    Die Rezidivrate von aktinischen Keratosen 6 Monaten nach Beendigung der Therapie
    Kosmetisches Ergebnis 6 Monaten nach Beendigung der Therapie
    Lokale Hautreaktion 10 sowie 30 Minuten, 2 und 7 Tage nach der PDT
    bestimmt
    Schmerzintensität 1, 5, 10, Minuten nach Beginn der Bestrahlung sowie 10 und 30 Minuten nach Beendigung der PDT
    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 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 Yes
    E.8.1.7.1Other trial design description
    observer-geblindet, gepaart, monozentrisch
    observer-blinded, paired, monocentric
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dasselbe IMP verwendet mit Okklusion
    the same IMP used under occlussion
    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.8.5The 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 examinations 6
    months after the therapy in 45 participants
    Das Ende der Studie ist nach der abgeschlossenen klinischen
    Kontrollen 6 Monate nach Beendigung der Therapie bei 45 Patienten
    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 months24
    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: 15
    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 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 state45
    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
    Die Patienten werden in Routinebetrieb der dermatologischen
    Ambulanz weiter betreut
    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 Decision2014-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-18
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