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    Summary
    EudraCT Number:2017-003626-32
    Sponsor's Protocol Code Number:PDT-PR2
    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:2017-11-16
    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 number2017-003626-32
    A.3Full title of the trial
    Photodynamic therapy (pdt) for skin rejuvenation: A pilotstudy evaluating the
    effectiveness of two modalities of photodynamic therapy in the treatment of photodamaged skin
    Topische photodynamische Therapie (PDT) als Verfahren zur Hautverjüngung: Pilotstudie mit Halbseitenvergleich zur Wirksamkeit von zwei verschiedenen Therapiemodalitäten bei der Behandlung aktinisch geschädigter Haut
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Photodynamic therapy for skin rejuvenation: A study comparing two different methods for the treatment of sundamaged skin
    Pilotstudie zu Photodynamischer Therapie (Lichttherapie) zur Hautverjüngung: Eine Studie mit zwei unterschiedlichen Methoden für die Behandlung sonnengeschädigter Haut
    A.3.2Name or abbreviated title of the trial where available
    ST-PDT vs. DL-PDT in treatment of photodamage
    ST-PDT vs. DL-PDT bei der Behandlung aktinisch geschädigter Haut
    A.4.1Sponsor's protocol code numberPDT-PR2
    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 Universitaet Wien, Univ. Klinik fuer Dermatologie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universitaet Wien, Univ. Klinik fuer Dermatologie
    B.5.2Functional name of contact pointUniv. Klinik fuer Dermatologie
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer 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-aminolaevulinic acid
    D.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21578
    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
    Photodamaged skin
    Aktinisch geschädigte Haut
    E.1.1.1Medical condition in easily understood language
    Sundamaged Skin
    Sonnengeschädigte Haut
    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 10068388
    E.1.2Term Actinic elastosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    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
    Comparing the effects of standard PDT vs. daylight PDT in patients with photodamaged skin on changes in visible
    skin aging. The changes will be determined by a clinical photoaging score 6 months after treatment.
    Vergleich von Standard PDT und Daylight PDT bezüglich Verbesserung der Hautqualität und der Zeichen der Hautalterung. Die Änderungen werden auf dem klinischen Photoaging Score ermittelt. Der Zeitpunkt des zweiten Follow-Ups, 6 Monate nach Behandlungsbeginn, wird zur Überprüfung der Hauptzielgröße herangezogen.
    E.2.2Secondary objectives of the trial
    Evaluation and comparison of the effects of the two methods 6 months after treatment on skin quality and signs of photoageing as measured with reflectance confocal microscopy and skin ultrasound; pain intensity, local phototoxic reaction; patients satisfaction
    Evaluierung und Vergleich der durch beide Methoden induzierten Veränderungen der Hautqualität und der Zeichen der Hautalterung 6 Monate nach Behandlungsbeginn gemessen durch apparative Verfahren (Ultraschall und konfokale Laserscanmikroskopie) ; Schmerzintensität; Intensität der lokalen Hautreaktion im bestrahlten Areal; Probandenzufriedenheit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients between 50 and 85 with photodamaged skin and a photoaging score of 8 or more as well as skin type I-III
    Patienten zwischen 50-85 Jahren mit aktinisch geschädigter Haut, einem photoaging score über 8 und Hauttyp I-III
    E.4Principal exclusion criteria
    Known allergy to aminlevulinic acid
    Patients with porphyria or taking photosensitizing drugs
    Patients with severe compromised general state
    Patients with other dermatological diseases in the treatment area
    Patient with another skin rejuvenation treatment in the last 6 moths
    Patients unable to stick to the study protocol
    Pregnant or lactating women
    Patients who are participating in another study
    Aminolävulinsäure-Unverträglichkeit
    Porphyrie oder Einnahme von photosensibilisierenden Medikamenten
    Schwere Beeinträchtigung des Allgemeinzustandes
    Andere dermatologische Erkrankungen im Behandlungsareal
    Personen, die in den letzten 6 Monaten hautverjüngende Therapien erhalten haben
    Unvermögen, den Behandlungsplan zu bewältigen bzw. den Pflichten des Studienteilnehmers nachzukommen
    Schwangere und stillende Frauen
    Teilnahme an einer anderen klinischen Studie
    E.5 End points
    E.5.1Primary end point(s)
    Changes of the Photoaging Score
    Veränderung des Photoaging Scores
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical control 6 months after treatment with both PDT , DL-PDT and ST-PDT.
    Klinische Kontrolle 6 Monate nach der beide PDT, DL-PDT und ST-PDT.
    E.5.2Secondary end point(s)
    Skin changes as measured with reflectance confocal microscopy and ultrasound, local phototoxic reaction, tolerability and patient
    satisfaction 3 and 6 moths after treatment
    Veränderungen der Haut gemessen durch Konfokale Mikroskopie und Ultraschall, lokale phototoxische Reaktionen,
    behandlungsassoziierte Schmerzen und Evaluierung der
    Patientenzufriedenheit, 3 und 6 Monate nach der Therapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Veränderungen der Haut gemessen durch konfokale Mikroskopie und Ultraschall 3 und 6 Monate nach Therapiebeginn
    Lokale phototoxische Reaktionen 10, 30 min sowie 7 Tage nach PDT
    Behandlungsassoziierte Schmerzen während der Standard PDT nach 1,5,10 Minuten sowie 10 und 30min nach Therapieende
    Behandlungsassoziierte Schmerzen während der Daylight PDT nach 1,30,60,90,120 Minuten sowie 10 und 30min nach Therapieende
    Evaluierung der Patientenzufriedenheit, 3 und 6 Monate nach der Therapiebeginn
    Skin changes as measured with reflectance confocal microscopy and ultrasound 3 and 6 months after initial treatment
    Local phototoxic reaction 10 and 30 minutes as well as 7 days after PDT
    Tolerability (pain) of st-PDT 1,5,10 minutes after the beginning as well as 10 and 30 minutes after finishing the therapy
    Tolerability (pain) of dl-PDT 1,30,60,90 und 120min minutes after the beginning as well as 10 and 30 minutes after finishing the therapy
    Patients satifaction 3 and 6 months after initial treatment
    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 Yes
    E.6.13.1Other scope of the trial description
    Observer-blinded, monocentric, prospective
    Untersucher-verblindet, monozentrisch, prospektiv
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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
    Untersucher-verblindet, monozentrisch, prospektiv
    Observer-blinded, monocentric, prospective
    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
    LVLS
    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 months18
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state20
    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 Decision2018-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-13
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