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    Clinical Trial Results:
    Treatment of photodamaged skin of the décolleté with fractional laser, radio-frequency microneedling, and photodynamic therapy

    Summary
    EudraCT number
    		 2018-000189-12
    Trial protocol
    		 DK  
    Global end of trial date
    18 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2020
    First version publication date
    12 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LS2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03573076
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg University Hospital
    Sponsor organisation address
    Nielsine Nielsens Vej 17, Opgang 9, Copenhagen, Denmark, 2400
    Public contact
    Dermatologisk forskningsafdeling, Bispebjerg Hospital, 0045 41184700, merete.haedersdal@regionh.dk
    Scientific contact
    Dermatologisk forskningsafdeling, Bispebjerg Hospital, 0045 41184700, merete.haedersdal@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
    01 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    In patients with photodamaged skin in the décolleté region, the objective is to investigate a non-ablative fractional thulium laser and a radio-frequency microneedling device as pre-treatment approaches for combination photodynamic therapy in treatment of photoaged skin and actinic keratoses.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Apr 2018
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    4
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark and private dermatological practices in Copenhagen, Denmark.

    Pre-assignment
    Screening details
    		 Patients were screened if they seemed to meet inclusion criteria.

    Period 1
    Period 1 title
    Baseline evaluation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Arm title
    		 Evaluation
    Arm description
    		 -
    Arm type
    		 Evaluation

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Normal saline

    Number of subjects in period 1
    		Evaluation
    Started
    12
    Completed
    12
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Thulium laser plus photodynamic therapy
    Arm description
    		 TL + PDT
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metyl aminolevulinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Methyl aminolevulinate 2% creme was applied once with and without thulium laser pre-treatment.

    Arm title
    		 Thulium laser
    Arm description
    		 TL alone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Normal saline

    Arm title
    		 Photodynamic therapy
    Arm description
    		 PDT alone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metyl aminolevulinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Methyl aminolevulinate 2% creme was applied once

    Arm title
    		 Control curettage
    Arm description
    		 Only lesion-specific (AK) curettage
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Thulium laser plus photodynamic therapy Thulium laser Photodynamic therapy Control curettage
    Started
    12
    12
    12
    12
    Completed
    12
    12
    12
    12
    Period 3
    Period 3 title
    Evaluation
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Thulium laser plus photodynamic therapy
    Arm description
    		 TL + PDT
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metyl aminolevulinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Methyl aminolevulinate 2% creme was applied once with and without thulium laser pre-treatment.

    Arm title
    		 Thulium laser
    Arm description
    		 TL alone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Normal saline

    Arm title
    		 Photodynamic therapy
    Arm description
    		 PDT alone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metyl aminolevulinate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Methyl aminolevulinate 2% creme was applied once

    Arm title
    		 Control curettage
    Arm description
    		 Only lesion-specific (AK) curettage
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The nature of the treatments do not allow the treating physician to be blinded. A separate assessor (physician) conducted the single-blind analyses.
    Number of subjects in period 3
    		Thulium laser plus photodynamic therapy Thulium laser Photodynamic therapy Control curettage
    Started
    12
    12
    12
    12
    Completed
    12
    12
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline evaluation
    Reporting group description
    		 -

    Reporting group values
    		 Baseline evaluation Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 69 (54 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Efficacy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Efficacy

    Subject analysis sets values
    		 Efficacy
    Number of subjects
    12
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    69 (54 to 76)
    Gender categorical
    Units: Subjects
        Female
    12
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Evaluation
    Reporting group description
    		 -
    Reporting group title
    Thulium laser plus photodynamic therapy
    Reporting group description
    		 TL + PDT

    Reporting group title
    Thulium laser
    Reporting group description
    		 TL alone

    Reporting group title
    Photodynamic therapy
    Reporting group description
    		 PDT alone

    Reporting group title
    Control curettage
    Reporting group description
    		 Only lesion-specific (AK) curettage
    Reporting group title
    Thulium laser plus photodynamic therapy
    Reporting group description
    		 TL + PDT

    Reporting group title
    Thulium laser
    Reporting group description
    		 TL alone

    Reporting group title
    Photodynamic therapy
    Reporting group description
    		 PDT alone

    Reporting group title
    Control curettage
    Reporting group description
    		 Only lesion-specific (AK) curettage

    Subject analysis set title
    Efficacy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Efficacy

    Primary: Clinical improvement in photodamage

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    End point title
    		 Clinical improvement in photodamage
    End point description
    End point type
    Primary
    End point timeframe
    Final evaluation (12 weeks)
    End point values
    		 Thulium laser plus photodynamic therapy Thulium laser Photodynamic therapy Control curettage
    Number of subjects analysed
    12
    12
    12
    12
    Units: 0-4
        median (inter-quartile range (Q1-Q3))
    1.000 (1.000 to 1.500)
    1.000 (0.500 to 1.500)
    0.500 (-0.875 to 1.250)
    0.000 (-0.500 to 0.100)
    Statistical analysis title
    		 TL-PDT compared with control
    Comparison groups
    Control curettage v Thulium laser plus photodynamic therapy
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
    Statistical analysis title
    		 TL compared with control
    Comparison groups
    Thulium laser v Control curettage
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
    Statistical analysis title
    		 PDT compared with control
    Comparison groups
    Photodynamic therapy v Control curettage
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.063
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Secondary: Treatment effect on AK lesions

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    End point title
    		 Treatment effect on AK lesions
    End point description
    End point type
    Secondary
    End point timeframe
    Final evaulation (12 weeks)
    End point values
    		 Thulium laser plus photodynamic therapy Thulium laser Photodynamic therapy Control curettage
    Number of subjects analysed
    12
    12
    12
    12
    Units: 100
        median (inter-quartile range (Q1-Q3))
    100 (90 to 100)
    90 (56 to 100)
    82 (70 to 100)
    55 (28 to 100)
    Statistical analysis title
    		 All interventions compared
    Comparison groups
    Thulium laser plus photodynamic therapy v Thulium laser v Photodynamic therapy v Control curettage
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.464
    Method
    		 Kruskal-wallis
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until final evaluation (12 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Photodynamic therapy is well-known and safe. The laser treatment was conducted expertly at our unversity hosptial, and neither expected nor saw any adverse events.

    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.
    Please see published article for a discussion on limitations.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31788828
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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
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