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    Clinical Trial Results:
    Comparison of Efficacy and Safety of Metvixia® Natural Daylight Photodynamic Therapy Versus Conventional Metvixia® Photodynamic Therapy in patients With grade I and II actinic keratosis of the scalp: a phase III trial

    Summary
    EudraCT number
    		 2014-003602-32
    Trial protocol
    		 FR  
    Global end of trial date
    22 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2021
    First version publication date
    01 May 2021
    Other versions
    Summary report(s)
    		 2014-003602-32_results summary
    2014-003602-32_publication

    Trial information

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    Trial identification
    Sponsor protocol code
    I14034/Daylight-PDT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02373371
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Limoges
    Sponsor organisation address
    2 Avenue Martin Lutrher King, Limoges, France, 87042
    Public contact
    Project manager, CHU de Limoges, 33 5 55 05 86 16 , abdeslam.bentaleb@chu-limoges.fr
    Scientific contact
    Dr Safae ASSIKAR, Investigator, CHU de Limoges, 33 05 55 05 5555, safae.assikar@chu-limoges.fr
    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
    14 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate clinical efficacy of daylight photodynamic therapy using Metvixia®compared to conventional PDT treatment using Metvixia®
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable French regulations regarding ethical committee review, competent authority, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2014
    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
    France: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    3
    From 65 to 84 years
    19
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 This monocentric study took place in France between March 2015 and December 2016. Patients included in the study were aged over 18 years and suffered from mild actinic keratosis (AK) (defined as slightly palpable AK, better felt than seen) and possibly moderate AK (moderately thick, easily felt and seen). The patients also acted as controls.

    Pre-assignment
    Screening details
    		 Patients with at least two comparable fields of AK on the face and scalp, with a minimum of five AKs in each area, were eligible. Main exclusion criteria were pigmented lesions, hypertrophic AK, non-melanoma skin cancer, AK treatment in the last month. The patients also acted as controls for the purpose of treatment comparison.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 daylight
    Arm description
    		 Scales and crusts were gently removed, and the entire treatment area was superficially scraped. Metvixia* was applied in a 1-mm thick layer to the entire treatment area and was kept uncovered on the side exposed to daylight . Patients exposed themselves continuously to daylight for 2 h, starting within 30 min of applying the MAL cream . Exposure to daylight was allowed if the weather was not rainy and if the temperature was above 10°C.
    Arm type
    		 Crossover

    Investigational medicinal product name
    Metvixia*
    Investigational medicinal product code
    Other name
    methyl aminolevulinate (MAL)
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Metvixia* 16% cream was applied in a 1-mm thick layer to the entire treatment area

    Arm title
    		 Blue light
    Arm description
    		 Scales and crusts were gently removed, and the entire treatment area was superficially scraped. Metvixia* was applied in a 1-mm thick layer to the entire treatment area and was covered. Patients started blue light exposure 3 h after the MAL cream was applied, using a Waldmann PDT (Herbert Waldmann GmbH & Co, Villingen-Schwenningen, Germany) 450 lamp at 10 J/cm2. The median duration of illumination ranged from 15 to 18 min.
    Arm type
    		 Crossover

    Investigational medicinal product name
    Metvixia*
    Investigational medicinal product code
    Other name
    methyl aminolevulinate (MAL)
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Metvixia* 16% cream was applied in a 1-mm thick layer to the entire treatment area

    Number of subjects in period 1
    		daylight Blue light
    Started
    13
    13
    Completed
    13
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 26 26
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 19 19
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    daylight
    Reporting group description
    		 Scales and crusts were gently removed, and the entire treatment area was superficially scraped. Metvixia* was applied in a 1-mm thick layer to the entire treatment area and was kept uncovered on the side exposed to daylight . Patients exposed themselves continuously to daylight for 2 h, starting within 30 min of applying the MAL cream . Exposure to daylight was allowed if the weather was not rainy and if the temperature was above 10°C.

    Reporting group title
    Blue light
    Reporting group description
    		 Scales and crusts were gently removed, and the entire treatment area was superficially scraped. Metvixia* was applied in a 1-mm thick layer to the entire treatment area and was covered. Patients started blue light exposure 3 h after the MAL cream was applied, using a Waldmann PDT (Herbert Waldmann GmbH & Co, Villingen-Schwenningen, Germany) 450 lamp at 10 J/cm2. The median duration of illumination ranged from 15 to 18 min.

    Primary: Percenatge of number of AK lesions cleared at the 3-month

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    End point title
    		 Percenatge of number of AK lesions cleared at the 3-month
    End point description
    End point type
    Primary
    End point timeframe
    At 3 months
    End point values
    		 daylight Blue light
    Number of subjects analysed
    13
    13
    Units: Number
        arithmetic mean (standard deviation)
    19.6 ± 6
    20 ± 6.9
    Statistical analysis title
    		 Principal analysis
    Statistical analysis description
    The main analysis is to compare at 3 month to e 0 the difference between the number of KA disappeared after Daylight PDTT and number of KA disappeared after Bluelight PDT) the 0 with a nonparametric test on paired data of signed Wilcoxon ranks.
    Comparison groups
    daylight v Blue light
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.846 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - The raw difference in the number of AK is not statistically different from 0 and the numbers of disappeared AK are not statistically significant between the two treatments

    Primary: Recurrence of lesions at Week 4

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    End point title
    		 Recurrence of lesions at Week 4 [2]
    End point description
    End point type
    Primary
    End point timeframe
    At Week 4
    Notes
    [2] - 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: No test was carried out because the 15% margin was no longer valid
    End point values
    		 daylight Blue light
    Number of subjects analysed
    6
    1
    Units: number
        arithmetic mean (standard deviation)
    0.3 ± 0.7
    0.2 ± 0.5
    No statistical analyses for this end point

    Secondary: Raw number of AK lesions cleared at week 4

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    End point title
    		 Raw number of AK lesions cleared at week 4
    End point description
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 daylight Blue light
    Number of subjects analysed
    13
    13
    Units: Number
        arithmetic mean (standard deviation)
    19.4 ± 6.1
    20.1 ± 6.7
    No statistical analyses for this end point

    Secondary: Raw number of AK lesions cleared at Week 24

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    End point title
    		 Raw number of AK lesions cleared at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 daylight Blue light
    Number of subjects analysed
    13
    13
    Units: Number
        arithmetic mean (standard deviation)
    19.7 ± 6.2
    20.2 ± 7.3
    No statistical analyses for this end point

    Secondary: Recurrence of lesions at Week 12

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    End point title
    		 Recurrence of lesions at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 12
    End point values
    		 daylight Blue light
    Number of subjects analysed
    9
    6
    Units: Number
        arithmetic mean (standard deviation)
    1.2 ± 1.2
    0.5 ± 0.8
    No statistical analyses for this end point

    Secondary: Recurrence of lesions at Week 24

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    End point title
    		 Recurrence of lesions at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    At Week 24
    End point values
    		 daylight Blue light
    Number of subjects analysed
    12
    10
    Units: Number
        arithmetic mean (standard deviation)
    2.4 ± 1.6
    1 ± 0.8
    No statistical analyses for this end point

    Secondary: Pain assessment

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    End point title
    		 Pain assessment
    End point description
    The pain felt after each procedure, was evaluated using a numerical scale from 0 (no pain) to 10 (extreme pain).
    End point type
    Secondary
    End point timeframe
    Pain recorder just after exposure to the light.
    End point values
    		 daylight Blue light
    Number of subjects analysed
    13
    13
    Units: Number
        arithmetic mean (standard deviation)
    1.2 ± 1.9
    5.1 ± 3.9
    Statistical analysis title
    		 Pain statistical analysis
    Statistical analysis description
    The analysis consists in comparing with 0 the difference in pain felt after treatment with Daylight-PDT and BleuLight PDT.
    Comparison groups
    Blue light v daylight
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - The pain felt after Daylight-PDT is significantly less than the pain felt after Blue light-PDT

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were recorder from 15/10/2014 to 15/10/2017
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Bluelight
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events were recorded . Pain was analyzed in the secondary end points.
    Serious adverse events
    		 Bluelight
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 26 (3.85%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Ischaemic stroke
    Additional description: left facial paralysis with episode of transient dysarthria. Hospitalization for suspicion of transient ischemic attack, aphasia, language disorder, left paralysisdyarthria. Treatment with anti-platelet aggregation agent + kardegic 300 mg +tahor 20 mg
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Bluelight
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31955461
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