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    Clinical Trial Results:
    Impact of thermo-mechanical intervention on Protoporphyrin IX accumulation and biodistribution in normal skin following topical 5-aminolevulinic acid at high and low vehicle viscosity

    Summary
    EudraCT number
    		 2018-004397-96
    Trial protocol
    		 DK  
    Global end of trial date
    27 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Oct 2020
    First version publication date
    10 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CF20112018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04221126
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Ethics Committee of the Capital Region of Denmark: H-1900394, Danish Medicine Agency: 2018-004397-96
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Nielsine Nielsens Vej 17, building 9, 2. Floor, Copenhagen NV, Denmark, 2400
    Public contact
    Merete Haedersdal, Katrine Togsverd-Bo, Camilla Foged, Department of Dermatology, +45 38636173, camilla.foged.01@regionh.dk
    Scientific contact
    Merete Haedersdal, Katrine Togsverd-Bo, Camilla Foged, Department of Dermatology, +45 38636173, camilla.foged.01@regionh.dk
    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
    09 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aimed to explore TMFI pretreatment before ALA incubation with cream and gel vehicles And quantify PpIX fluorescence at the skin surface and inside skin.
    Protection of trial subjects
    Biopsies were sampled under local anesthesia with 2 ml Lidocaine with adrenaline (Lidocain with adrenalin, SAD) 20 mg/ml+5mikrog/ml adrenaline and 20 mg/ml+5mikrog/ml lidocaine. Pain during pretreatment with TMFI were evaluated on an numeric scale.
    Background therapy
    		 Non treatments that are not test or comparator
    Evidence for comparator
    		 ALA was dissolved in a a cream-vehicle and a gel-vehicle . The rationale behind this was that hydrophilic drugs (e.g. ALA) was dissolved in a low viscosity liquid-based vehcle may be more readily distributed within the skin compared to drugs dissolved in a high viscosity vehicle.
    Actual start date of recruitment
    29 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The participants will be recruited through the website www.forsoegsperson.dk, announcement in MOK (Mediciner Organisationernes Kommunikationsorgan) and on their Facebook page, announcement in the Facebook group “Medicin – Københavns Universitet” and notices at Bipsebjerg Hospital and Panum Instituttet.

    Pre-assignment
    Screening details
    		 Screening criteria: Healthy, above 18 years, Fitzpatrick I-III and normal skin on the upper back, fertile women w/ negative U-hCG and w/ use of safe anticontraceptive during the entire study period. 32 participants screened for inclusion, 16 included. Excluded due to folliculitis, acne etc on the upper back.

    Pre-assignment period milestones
    Number of subjects started
    		 16
    Number of subjects completed
    		 16

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Randomization will be conducted with consecutively numbered closed, non-transparent envelopes containing a computer-generated allocation to specific test areas. The envelopes will be taken to use in numeric order and will be opened at the day of inclusion. Participants are non-blinded. Investigators are non-blinded in the clinical evaluation. A blinded investigator will evaluate the microscopy.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 TMFI pretreatment + cream
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gliolan
    Investigational medicinal product code
    PDL506
    Other name
    5-aminolevulinic acid
    Pharmaceutical forms
    Cream, Gel
    Routes of administration
    Topical use
    Dosage and administration details
    125 uL per test area

    Arm title
    		 No pretreatment + gel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gliolan
    Investigational medicinal product code
    PD L 506
    Other name
    5-aminolevulinic acid
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    125 uL per test area

    Arm title
    		 No pretreatment + cream
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gliolan
    Investigational medicinal product code
    PDL506
    Other name
    5-aminolevulinic acid
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    125 uL per test area

    Arm title
    		 TMFI pretreatment + gel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gliolan
    Investigational medicinal product code
    PDL506
    Other name
    5-aminolevulinic acid
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    125 uL per test area

    Number of subjects in period 1
    		TMFI pretreatment + cream No pretreatment + gel No pretreatment + cream TMFI pretreatment + gel
    Started
    16
    16
    16
    16
    Completed
    16
    16
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention (overall period)
    Reporting group description
    		 Pre-study (Study A) including 4 participants and the actual study (Study B) including 12 participants.

    Reporting group values
    		 Intervention (overall period) Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        adults
    		 16 16
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    TMFI pretreatment + cream
    Reporting group description
    		 -

    Reporting group title
    No pretreatment + gel
    Reporting group description
    		 -

    Reporting group title
    No pretreatment + cream
    Reporting group description
    		 -

    Reporting group title
    TMFI pretreatment + gel
    Reporting group description
    		 -

    Primary: PpIX fluorescence at skin surface photometer

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    End point title
    		 PpIX fluorescence at skin surface photometer
    End point description
    End point type
    Primary
    End point timeframe
    Skin surface PpIX fluorescence fotos + photometer from baseline - 3 hours.
    End point values
    		 TMFI pretreatment + cream No pretreatment + gel No pretreatment + cream TMFI pretreatment + gel
    Number of subjects analysed
    16
    16
    16
    16
    Units: AU
        median (inter-quartile range (Q1-Q3))
    52 (41 to 63)
    20.5 (13 to 35)
    43.5 (28 to 52)
    36 (24 to 49)
    Statistical analysis title
    		 Wilcoxon
    Comparison groups
    TMFI pretreatment + gel v No pretreatment + cream v No pretreatment + gel v TMFI pretreatment + cream
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: PpIX fluorescence at skin surface photos

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    End point title
    		 PpIX fluorescence at skin surface photos
    End point description
    End point type
    Primary
    End point timeframe
    From baseline until 3 hours.
    End point values
    		 TMFI pretreatment + cream No pretreatment + gel No pretreatment + cream TMFI pretreatment + gel
    Number of subjects analysed
    16
    16
    16
    16
    Units: AU
        median (inter-quartile range (Q1-Q3))
    7848 (4285 to 12836)
    3723 (1722 to 5449)
    5441 (2612 to 8235)
    4591 (3821 to 7398)
    Statistical analysis title
    		 Wilcoxon
    Comparison groups
    TMFI pretreatment + cream v No pretreatment + gel v No pretreatment + cream v TMFI pretreatment + gel
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study start until 14 days after study day.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SUSARs
    Dictionary version
    1
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
    Skin and subcutaneous tissue disorders
    Hyperpigmentation
    Additional description: At day 14 follow-up, two participants developed mild post-inflammatory hyperpigmentation in all ALA-test areas that was unrelated to TMFI exposure
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2

    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.
    normal skin on the back opposed to thin facial skin or diseased skin with localized hyperkeratoses, TMFI settings
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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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