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    Summary
    EudraCT Number:2015-002537-22
    Sponsor's Protocol Code Number:PDT-PR1
    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:2016-12-23
    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 number2015-002537-22
    A.3Full title of the trial
    Photodynamic therapy for skin rejuvenation: A pilotstudy evaluating the
    effectiveness of 5-aminolevulinic acid -based photodynamic therapy in the
    treatment of photodamaged skin
    Topische photodynamische Therapie mit 5-Aminolävulinsäure (ALA-PDT)
    als Verfahren zur Hautverjüngung (Skin photorejuvenation) - Pilotstudie
    zur Wirksamkeit von ALA-PDT 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 pilotstudy using LED light and the substance 5-aminolevulinic acid
    Pilotstudie zu Photodynamischer Therapie mit LED als Lichtquelle und die Substanz 5-Aminolävulinsäure (ALA-PDT) für Hautverjüngung
    A.3.2Name or abbreviated title of the trial where available
    PDT with LED in treatment of photodamage
    PDT mit LED bei der Behandlung aktinisch geschädigter Haut
    A.4.1Sponsor's protocol code numberPDT-PR1
    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
    Photodamaged 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 19.1
    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 19.1
    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
    Evaluating the effectiveness of ALA-PDT in patients with photodameged skin concerning cosmetic results and the change of skin quality and skinaging 6 months after treatment
    Ziel dieser Studie ist, die Wirksamkeit von ALA-PDT mit LED als Lichtquelle bei der Behandlung aktinisch geschädigter Haut zu evaluieren (Verminderung der Hautalterung 6 Monate nach der PDT)
    E.2.2Secondary objectives of the trial
    To evaluate the change of skin thickness ,tolerability , local phototoxic reaction after PDT with with LED light and atients satisfaction in patients with photodamaged skin 6 moths after treatment
    Evaluierung der Veränderung der Hautdicke, der Intensität des
    behandlungsassoziierten Schmerzes und der lokalen phototoxischen
    Hautreaktion während und nach der Therapie mit PDT mit LED als Lichtquelle sowie die globale Patientenzufriedenheit bei Patienten mit aktinisch geschädigter Haut, 6 Monate nach der Behandlung
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients between 40 and 80 with photodamaged skin and a photoaging
    Score of 4 or more as well as skin type I-III
    Patienten zwischen 40-80 Jahren mit aktinisch geschädigter Haut und mit einem Photoaging Score von 4 oder mehr sowie 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
    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
    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 3 and 6 months after treatment with PDT with LED
    Klinische Kontrolle 3 und 6 Monate nach der PDT mit LED
    E.5.2Secondary end point(s)
    Skin thickness, local phototoxic reaction, tolerability and patient
    satisfaction 3 and 6 moths after treatment
    Veränderungen der Hautdicke, 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
    skin thickness 3 and 6 months after treatment
    Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days
    after therapy Tolerability (pain) 1,5,10 minutes after the beginning as
    well as 10 and 30 minutes after finishing the therapy
    Hautdicke 3 und 6 Monate nach der Behandlung
    Lokale Hautreaktion 10 sowie 30 Minuten und 7 Tage nach der PDT
    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) 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-geblindet, 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.8.2.4Number 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 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 years1
    E.8.9.1In the Member State concerned months0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state13
    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 Decision2017-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-14
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