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    Clinical Trial Results:
    A Blinded, Prospective, Randomised, Placebo-Controlled, Multi-Centre, Split-Face Study of Photodynamic Therapy With Metvix 160 mg/g Cream in Subjects With Acne Vulgaris.

    Summary
    EudraCT number
    		 2004-002367-24
    Trial protocol
    		 SE  
    Global end of trial date
    02 May 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2022
    First version publication date
    02 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PC TA001/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D SNC
    Sponsor organisation address
    Les templiers, 2400 Routes des colles, Biot, France, 06410
    Public contact
    CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
    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
    02 May 2005
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial was to evaluate efficacy and safety of photodynamic therapy (PDT) with Metvix 160 mg/g cream compared to placebo in subjects with moderate inflammatory acne vulgaris in the face.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2004
    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
    Norway: 18
    Country: Number of subjects enrolled
    Sweden: 12
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 30 subjects was enrolled in the study from 3 sites in Europe.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Metvix® PDT
    Arm description
    		 Subjects were given 4 tubes of of Metvix cream. Each tube contain 2 grams of cream. The cream was applied evenly in thin manner on and left for 3 hours (Treatment 1 on Week 1 and Treatment 2 on Week 2). Illumination started immediately after removal of the dressing and the cream from the skin. The side of the face were the cream was applied first did preferably receive illumination first. The average time needed for a light dose of 37 J/cm2 was about 8 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metvix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    External use
    Dosage and administration details
    Metvix cream applied on skin for 3 hours.

    Arm title
    		 Placebo Matched Metvix
    Arm description
    		 Subjects were given 4 tubes of of Placebo cream. Each tube contain 2 grams of cream. The cream was applied evenly in thin manner and left for 3 hours (Treatment 1 on Week 1 and Treatment 2 on Week 2). Illumination started immediately after removal of the dressing and the cream from the skin. The side of the face were the cream was applied first did preferably receive illumination first. The average time needed for a light dose of 37 J/cm2 was about 8 minutes.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Metvix® PDT Placebo Matched Metvix
    Started
    30
    30
    Completed
    27
    27
    Not completed
    3
    3
         Adverse Events
    3
    3

    Baseline characteristics

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

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 25 25
    Race
    Units: Subjects
        Caucasian
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Metvix® PDT
    Reporting group description
    		 Subjects were given 4 tubes of of Metvix cream. Each tube contain 2 grams of cream. The cream was applied evenly in thin manner on and left for 3 hours (Treatment 1 on Week 1 and Treatment 2 on Week 2). Illumination started immediately after removal of the dressing and the cream from the skin. The side of the face were the cream was applied first did preferably receive illumination first. The average time needed for a light dose of 37 J/cm2 was about 8 minutes.

    Reporting group title
    Placebo Matched Metvix
    Reporting group description
    		 Subjects were given 4 tubes of of Placebo cream. Each tube contain 2 grams of cream. The cream was applied evenly in thin manner and left for 3 hours (Treatment 1 on Week 1 and Treatment 2 on Week 2). Illumination started immediately after removal of the dressing and the cream from the skin. The side of the face were the cream was applied first did preferably receive illumination first. The average time needed for a light dose of 37 J/cm2 was about 8 minutes.

    Primary: Percent Change From Baseline in Inflammatory Lesions Counts to Visit 7

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    End point title
    		 Percent Change From Baseline in Inflammatory Lesions Counts to Visit 7 [1]
    End point description
    Inflationary lesions included Papules a small, solid elevation less than one centimetre in diameter. Pustules a small, circumscribed elevation of the skin, which contains yellow-white exudate. Nodules/Cysts a circumscribed, elevated, lesion generally more than 1.0 cm in diameter. Intent to Treat population that consisted of the entire population enrolled and randomised. Intent to treat analysis population was used for this outcome.
    End point type
    Primary
    End point timeframe
    Visit 7
    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: Only descriptive summary statistics was planned for this endpoint.
    End point values
    		 Metvix® PDT Placebo Matched Metvix
    Number of subjects analysed
    30
    30
    Units: Percent change
        arithmetic mean (standard deviation)
    45.7 ( 34.5 )
    26.6 ( 38.6 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With an Investigator's Global Assessment (IGA) Score of 0 to 4

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    End point title
    		 Number of Subjects With an Investigator's Global Assessment (IGA) Score of 0 to 4
    End point description
    IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Higher score indicates severity of disease. ITT population was used for this analysis.
    End point type
    Secondary
    End point timeframe
    At Visit 1, 4, 6 and 7
    End point values
    		 Metvix® PDT Placebo Matched Metvix
    Number of subjects analysed
    30
    30
    Units: subjects
        Visit 1: Clear
    0
    0
        Visit 1: Almost clear
    0
    0
        Visit 1: Mild
    0
    0
        Visit 1: Moderate
    24
    23
        Visit 1: Severe
    6
    7
        Visit 4: Clear
    0
    0
        Visit 4: Almost clear
    1
    1
        Visit 4: Mild
    11
    7
        Visit 4: Moderate
    16
    17
        Visit 4: Severe
    2
    5
        Visit 6: Clear
    0
    0
        Visit 6: Almost clear
    10
    4
        Visit 6: Mild
    8
    7
        Visit 6: Moderate
    12
    17
        Visit 6: Severe
    0
    2
        Visit 7: Clear
    1
    0
        Visit 7: Almost clear
    18
    3
        Visit 7: Mild
    12
    13
        Visit 7: Moderate
    8
    11
        Visit 7: Severe
    1
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Event

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    End point title
    		 Number of Subjects with Adverse Event [2]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subjects administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 1 year
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only arm applicable for this endpoint is reported.
    End point values
    		 Metvix® PDT
    Number of subjects analysed
    30
    Units: subjects
    21
    No statistical analyses for this end point

    Secondary: Number of Subjects With Non-Inflammatory Lesions Counts at Visit 7

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    End point title
    		 Number of Subjects With Non-Inflammatory Lesions Counts at Visit 7
    End point description
    Non - inflammatory lesions included: Open Comedones - A mass of sebaceous material that is impacted behind an open follicular orifice (blackhead). Closed Comedone - A mass of sebaceous material that is impacted behind a closed follicular orifice (whitehead). Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    Visit 7
    End point values
    		 Metvix® PDT Placebo Matched Metvix
    Number of subjects analysed
    30
    30
    Units: Subjects
    30
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 1 year
    Adverse event reporting additional description
    Safety population that included all subjects included in this study received at least one PDT treatment and all subjects are therefore included in the safety population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Overall subjects
    Reporting group description
    		 -

    Serious adverse events
    		 Overall subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 30 (70.00%)
    Skin and subcutaneous tissue disorders
    PAIN OF SKIN
         subjects affected / exposed
    20 / 30 (66.67%)
         occurrences all number
    20
    ERYTHEMA
         subjects affected / exposed
    18 / 30 (60.00%)
         occurrences all number
    18
    SKIN SWELLING
         subjects affected / exposed
    11 / 30 (36.67%)
         occurrences all number
    11
    DERMATITIS EXFOLIATIVE NOS
         subjects affected / exposed
    7 / 30 (23.33%)
         occurrences all number
    7
    ACNE AGGRAVATED
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    DRY SKIN
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    CELLULITIS
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    SKIN TENDERNESS
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    SCAB
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    BLISTER
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    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
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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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