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    Clinical Trial Results:
    Title of the publication Peptidase inhibitor 3 and chemokine ligand 27 may serve as biomarkers for actinic keratoses in organ transplant recipients (Eur J Dermatol. 2019 Jun 1;29(3):259-267. doi: 10.1684/ejd.2019.3559.) former title: Topical imiquimod 5% cream therapy versus photodynamic therapy with methyl-aminolaevulinate 16% cream of actinic keratoses in organ transplant recipients

    Summary
    EudraCT number
    2010-024623-24
    Trial protocol
    AT  
    Global end of trial date
    10 Dec 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    29 May 2020
    First version publication date
    29 May 2020
    Other versions
    Summary report(s)
    Peptidase inhibitor 3 and chemokine ligand 27 may serve as biomarkers for actinic keratoses in organ transplant recipients

    Trial information

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    Trial identification
    Sponsor protocol code
    IPDTAKOTR/V04/24.09.11
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna, Department Dermatology
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Univ. Klinik f. Dermatologie, Medizinische Universität Wien, Univ. Klinik f. Dermatologie, +43 1404007700, stanislava.tzaneva@meduniwien.ac.at
    Scientific contact
    Univ. Klinik f. Dermatologie, Medizinische Universität Wien, Univ. Klinik f. Dermatologie, +43 1404007700, stanislava.tzaneva@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
    10 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream in the treatment of actinic keratoses in OTR, each pat was his own control i.e. Molecular profiling of tissue samples in organ transplant recipients (OTR) to assess an early and minimally invasive identification of actinic keratosis (AK). The aim of this study was to compare mRNA expression profiles of genetic markers of AK before and after treatment, employing two different field-therapies, and to correlate the results with histological and clinical parameters.
    Protection of trial subjects
    Ten patients (2 women and 8 men) with multiple AK and field cancerisation were enrolled into the study each patient was his own control From the target lesions, 3-mm punch biopsies were obtained from each site initially, then at week 2 (immediately after the second PDT, and 2 weeks after the initiation of IMI, respectively), and 3 months after completion of the active treatment period. The punch biopsies were taken under local anaesthesia, and appropriate wound management was carried out. For photodynamic therapy (PDT) as well as for photodynamic diagnosis (PDD), methyl-5-aminolevulinate 16% cream (Metvix© Cream, Galderma, France) was employed as photosensitizer, applied in a 1-mm thick layer, covering 50cm2. Before the procedure, local anaesthesia (lidocaine 1%, without vasoconstrictor) was applied, if required. During illumination, cooling was carried out by the integrated air-forced cooling device and/or spray with thermal water (Avene, France). All patients were evaluated for the intensity of pain during light exposure using a visual analogue scale (VAS), considering 0 as absence of pain and 10 as the most severe pain. The skin areas were covered after each treatment or PDD and the patients instructed to prevent exposure to direct light for 48 hours and to apply a sunblock in the following days.
    Background therapy
    Prior to initiation of the study, ketoconazole shampoo once daily and commercially available topical steroid foam was prescribed for one week for treatment of the scalp region, in order to reduce scales due to seborrheic eczema. If hyperkeratotic AKs were present at the same time, a local therapy with 10% salicyl vaseline once daily in the evening was given for one week. Afterwards there was a wash out period for a week without any local therapy. All patients received painkillers after PDT, ef necessary
    Evidence for comparator
    The reduction of the AKs in the photodynamic therapy (PDT) area vs topical imiquimod had to beassessed clinically, and mRNA expression profiles of various genetic markers before, during and 3 months after therapy were compared for the two treatment modalities.
    Actual start date of recruitment
    02 Jan 2012
    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: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    5
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The patients were recruited from a dedicated outpatient clinic for organ transplant recipients at the Department of Dermatology, Medical University of Vienna. The requirement was the presence ofwo anatomically separated contralateral areas of AKs on the face or forehead which could be selected, at a minimum distance of 5cm

    Pre-assignment
    Screening details
    At baseline, all patients were clinically evaluated, and two anatomically separated contralateral areas of the face or forehead were selected, at a minimum distance of 5cm, each area of comparable size and extent. A target lesion, a lesion located in the middle of this area was selected, an at least AK grade II with a diameter of at least 8 mm

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    it was an intraindividual trial; each patient was his own control

    Arms
    Are arms mutually exclusive
    No

    Arm title
    PDT-treatment
    Arm description
    a distinct area of field cancerisation (Face) in organ transplant patients (OTP), treated employing PDT with two treatment cycles (two weeks apart) of methyl-aminolevulinate 16% cream-PDT Prior to initiation of the study, ketoconazole shampoo, once daily, and commercially available topical steroid foam was prescribed for one week for treatment of the scalp region, in order to reduce scales due to seborrhoic eczema an at least AK grade II with a diameter of at least 8 mm was chosen as ‘target lesion’ in the treatment area and was biopsied, the 3mm tissue samples subsequently snap frozen in liquid nitrogen From the target lesions, 3-mm punch biopsies were obtained from not only initially, but then at week 2 (immediately after the second PDT, and 3 months after completion of the active treatment period. The treatment areas were also recorded by photodynamic diagnosis (PDD).
    Arm type
    Experimental

    Investigational medicinal product name
    methyl-5-aminolevulinate hydrochloride (methyl-aminolevulinate 16% cream-PDT
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    field therapy with PDT with two treatment cycles (2 weeks apart) of methyl-5-aminolaevulinate-PDT

    Arm title
    imiquimod
    Arm description
    An area of field cancerisation was treated with Imiquimod 5% cream (three times a week for four weeks, carried out by the patients themselves) Prior to initiation of the study, ketoconazole shampoo and topical steroid foam was prescribed for one week The selected treatment area was recorded by photodynamic diagnosis (PDD). From a target lesions, 3-mm punch biopsies were obtained initially, then at week 2, and 2 weeks after the initiation of Imiquimod 5% cream as well as 3 months after completion of the active treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    Imiquimod 5% Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Imiquimod 5% cream (three times a week for four weeks, carried out by the patients themselves

    Number of subjects in period 1
    PDT-treatment imiquimod
    Started
    10
    10
    Completed
    9
    9
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PDT-treatment
    Reporting group description
    a distinct area of field cancerisation (Face) in organ transplant patients (OTP), treated employing PDT with two treatment cycles (two weeks apart) of methyl-aminolevulinate 16% cream-PDT Prior to initiation of the study, ketoconazole shampoo, once daily, and commercially available topical steroid foam was prescribed for one week for treatment of the scalp region, in order to reduce scales due to seborrhoic eczema an at least AK grade II with a diameter of at least 8 mm was chosen as ‘target lesion’ in the treatment area and was biopsied, the 3mm tissue samples subsequently snap frozen in liquid nitrogen From the target lesions, 3-mm punch biopsies were obtained from not only initially, but then at week 2 (immediately after the second PDT, and 3 months after completion of the active treatment period. The treatment areas were also recorded by photodynamic diagnosis (PDD).

    Reporting group title
    imiquimod
    Reporting group description
    An area of field cancerisation was treated with Imiquimod 5% cream (three times a week for four weeks, carried out by the patients themselves) Prior to initiation of the study, ketoconazole shampoo and topical steroid foam was prescribed for one week The selected treatment area was recorded by photodynamic diagnosis (PDD). From a target lesions, 3-mm punch biopsies were obtained initially, then at week 2, and 2 weeks after the initiation of Imiquimod 5% cream as well as 3 months after completion of the active treatment period.

    Reporting group values
    PDT-treatment imiquimod Total
    Number of subjects
    10 10
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.6 ± 7.199 69.6 ± 7.199 -
    Gender categorical
    Units: Subjects
        Female
    2 2 2
        Male
    8 8 8

    End points

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    End points reporting groups
    Reporting group title
    PDT-treatment
    Reporting group description
    a distinct area of field cancerisation (Face) in organ transplant patients (OTP), treated employing PDT with two treatment cycles (two weeks apart) of methyl-aminolevulinate 16% cream-PDT Prior to initiation of the study, ketoconazole shampoo, once daily, and commercially available topical steroid foam was prescribed for one week for treatment of the scalp region, in order to reduce scales due to seborrhoic eczema an at least AK grade II with a diameter of at least 8 mm was chosen as ‘target lesion’ in the treatment area and was biopsied, the 3mm tissue samples subsequently snap frozen in liquid nitrogen From the target lesions, 3-mm punch biopsies were obtained from not only initially, but then at week 2 (immediately after the second PDT, and 3 months after completion of the active treatment period. The treatment areas were also recorded by photodynamic diagnosis (PDD).

    Reporting group title
    imiquimod
    Reporting group description
    An area of field cancerisation was treated with Imiquimod 5% cream (three times a week for four weeks, carried out by the patients themselves) Prior to initiation of the study, ketoconazole shampoo and topical steroid foam was prescribed for one week The selected treatment area was recorded by photodynamic diagnosis (PDD). From a target lesions, 3-mm punch biopsies were obtained initially, then at week 2, and 2 weeks after the initiation of Imiquimod 5% cream as well as 3 months after completion of the active treatment period.

    Primary: Reduction of number of lesions after 12 months treatment compared to baseline

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    End point title
    Reduction of number of lesions after 12 months treatment compared to baseline [1]
    End point description
    CRR = proportion of healed AKs compared to baseline AKs; assumption: 80% CRR for PDT and 60% CRR for Imiquimod; alpha: 0.05, beta: 0.80 statistical method: McNemar Test, paired T-Test
    End point type
    Primary
    End point timeframe
    4 weeks after completion of treatment - complete response rate (CRR)
    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: Statistical analysis was performed within each arm (between different timepoints) but not between the arms.
    End point values
    PDT-treatment imiquimod
    Number of subjects analysed
    9
    9
    Units: percent
        median (full range (min-max))
    59.8 (20 to 100)
    70.8 (20 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment procedure (either during PDT or self-application of Imiquimod) and the period after - in the healing period
    Adverse event reporting additional description
    There were no serious adverse effects Tolerance for PDT was very good (local anesthesia), all except 1 pat tolerated the full Tx. Most common side effect erythema (subsided within few days). Imiquimod Th: all patients erythema; 1 pat ulceration, 2 pat flue-like symptoms
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    PDT-treatment
    Reporting group description
    a distinct area of field cancerisation (Face) in organ transplant patients (OTP), treated employing PDT with two treatment cycles (two weeks apart) of methyl-aminolevulinate 16% cream-PDT Prior to initiation of the study, ketoconazole shampoo, once daily, and commercially available topical steroid foam was prescribed for one week for treatment of the scalp region, in order to reduce scales due to seborrhoic eczema an at least AK grade II with a diameter of at least 8 mm was chosen as ‘target lesion’ in the treatment area and was biopsied, the 3mm tissue samples subsequently snap frozen in liquid nitrogen From the target lesions, 3-mm punch biopsies were obtained from not only initially, but then at week 2 (immediately after the second PDT, and 3 months after completion of the active treatment period. The treatment areas were also recorded by photodynamic diagnosis (PDD).

    Reporting group title
    imiquimod
    Reporting group description
    An area of field cancerisation was treated with Imiquimod 5% cream (three times a week for four weeks, carried out by the patients themselves) Prior to initiation of the study, ketoconazole shampoo and topical steroid foam was prescribed for one week The selected treatment area was recorded by photodynamic diagnosis (PDD). From a target lesions, 3-mm punch biopsies were obtained initially, then at week 2, and 2 weeks after the initiation of Imiquimod 5% cream as well as 3 months after completion of the active treatment period.

    Serious adverse events
    PDT-treatment imiquimod
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    PDT-treatment imiquimod
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 10 (30.00%)
    General disorders and administration site conditions
    ulceration
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    flu-like symptom
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    we were not able to recruit the planned number of patients
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