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    Clinical Trial Results:
    Photodynamic therapy for skin rejuvenation: A pilotstudy evaluating the effectiveness of 5-aminolevulinic acid -based photodynamic therapy in the treatment of photodamaged skin

    Summary
    EudraCT number
    		 2015-002537-22
    Trial protocol
    		 AT  
    Global end of trial date
    23 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Sep 2020
    First version publication date
    04 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PDT-PR1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien, Univ. Klinik f. Dermatologie
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria,
    Public contact
    Univ. Klinik fuer Dermatologie, Medizinische Universitaet Wien, Univ. Klinik fuer Dermatologie, +43 14040077020, sonja.radakovic@meduniwien.ac.at
    Scientific contact
    Univ. Klinik fuer Dermatologie, Medizinische Universitaet Wien, Univ. Klinik fuer Dermatologie, +43 14040077020, sonja.radakovic@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluating the effectiveness of ALA-PDT in patients with photodameged skin concerning cosmetic results and skinageing 6 months after treatment
    Protection of trial subjects
    insurance, patient informed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    9
    From 65 to 84 years
    2
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 13 Patients were recruited between January 2017 and September 2017

    Pre-assignment
    Screening details
    		 general medical history, clinical status, informed consent

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ALA- PDT
    Arm description
    		 -
    Arm type
    		 ALA-PDT therapy

    Investigational medicinal product name
    5-aminolaevulinic acid (Ameluz)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    BF-200 aminolaevulinic acid was applied to the face 90 minutes before red-light PDT treatment.

    Number of subjects in period 1
    		ALA- PDT
    Started
    13
    Completed
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        45-90
    		 13 13
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 62.85 (47 to 89) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 0 0
        not specified
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    ALA- PDT
    Reporting group description
    		 -

    Primary: Changes of the Photoaging Score

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    End point title
    		 Changes of the Photoaging Score [1]
    End point description
    End point type
    Primary
    End point timeframe
    6 months after first PDT treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: A clinical photoaging score to analyse visual signs of skin ageing was assessed in patients with photodameged skin at baseline and six months after the first treatment. Only descriptive statistics were used.
    End point values
    		 ALA- PDT
    Number of subjects analysed
    13
    Units: photoageing score
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    between patient inclusion and last visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    ALA-PDT
    Reporting group description
    		 -

    Serious adverse events
    		 ALA-PDT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ALA-PDT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: at the application site
         subjects affected / exposed
    13 / 13 (100.00%)
         occurrences all number
    37
    Oedema
    Additional description: at/near the application site
         subjects affected / exposed
    12 / 13 (92.31%)
         occurrences all number
    30
    Pain
         subjects affected / exposed
    13 / 13 (100.00%)
         occurrences all number
    33

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jan 2017
    inclusion criteria: age 45-90

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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