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    Clinical Trial Results:
    A double blinded, prospective, randomized, vehicle controlled, multi-center study of photodynamic therapy with Visonac cream in patients with acne vulgaris

    Summary
    EudraCT number
    		 2012-001296-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Apr 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2020
    First version publication date
    07 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PCTA206/11
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01347879
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Photocure ASA
    Sponsor organisation address
    Hoffsveien 4, Oslo, Norway, NO-0275
    Public contact
    Clinical Trials information, Photocure, 47 22062210, info@photocure.no
    Scientific contact
    Clinical Trials information, Photocure, 47 22062210, info@photocure.no
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000698-PIP02-10
    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 Nov 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy and safety of Visonac PDT in patients with severe acne, score 4 on the IGA scale
    Protection of trial subjects
    The light source has a built-in fan which cools the treatment area during illumination. If the patient requests a pause in light treatment, the illumination may be paused and started again. After illumination the patients may take “over-the-counter NSAIDS” at the dose recommended on label.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2011
    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
    United States: 153
    Worldwide total number of subjects
    153
    EEA total number of subjects
    0
    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)
    94
    Adults (18-64 years)
    59
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Start of recruitment 7 July 2011 End of recruitment 11 January 2012 Study center(s): 15 centers in the US

    Pre-assignment
    Screening details
    		 Discontinue before first study treatment: topical acne treatments at least 14 days, oral antibiotics: 1 month, oral isotretinoin at least 6 months, medicated cleansers. Any systemic hormonal treatment for reasons other than acne unchanged during 3 months before first study treatment.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    This was a randomized, double-blind study. The vehicle cream was similar in appearance and consistency to the active (Visonac) cream. To avoid the risk of unblinding as a consequence of local AEs, the entire treatment procedure and recording of AEs was conducted by an investigator or designee who was not involved in efficacy evaluations.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Visonac cream with PDT
    Arm description
    		 Test product and red light illumination
    Arm type
    		 Experimental

    Investigational medicinal product name
    Visonac
    Investigational medicinal product code
    not applicable
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Visonac (MAL cream 80 mg/g), applied 1.5 hours under occlusion, before illumination with red light

    Arm title
    		 Vehicle cream and PDT
    Arm description
    		 Vehicle cream and red light illumination
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Not applicable
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Vehicle cream, applied 1.5 hours under occlusion, before illumination with red light

    Number of subjects in period 1
    		Visonac cream with PDT Vehicle cream and PDT
    Started
    100
    53
    Completed
    83
    46
    Not completed
    17
    7
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    12
    -
         Other
    3
    1
         Non-compliance
    -
    1
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Visonac cream with PDT
    Reporting group description
    		 Test product and red light illumination

    Reporting group title
    Vehicle cream and PDT
    Reporting group description
    		 Vehicle cream and red light illumination

    Reporting group values
    		 Visonac cream with PDT Vehicle cream and PDT Total
    Number of subjects
    		 100 53 153
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 59 35 94
        Adults (18-64 years)
    		 41 18 59
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 44 22 66
        Male
    		 56 31 87

    End points

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    End points reporting groups
    Reporting group title
    Visonac cream with PDT
    Reporting group description
    		 Test product and red light illumination

    Reporting group title
    Vehicle cream and PDT
    Reporting group description
    		 Vehicle cream and red light illumination

    Primary: Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).

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    End point title
    		 Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to 12 weeks after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Lesion counts
        arithmetic mean (standard deviation)
    -15.6 ( 16.4 )
    -7.8 ( 21.4 )
    Statistical analysis title
    		 Absolute change in facial inflam. lesion counts
    Statistical analysis description
    The primary efficacy analysis was based on the ITT Analysis Set, comprising all randomized patients who had any aspect of study treatment initiated with imputation for missing data (last observation carried forward [LOCF]).
    Comparison groups
    Visonac cream with PDT v Vehicle cream and PDT
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.006
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean
    Point estimate
    -7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 -2.2
    Notes
    [1] - Fixed terms for treatment and center and the baseline lesion count as covariate

    Secondary: Percent change from baseline in facial inflammatory lesion counts

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    End point title
    		 Percent change from baseline in facial inflammatory lesion counts
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to 12 weeks after the first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: percent
        median (full range (min-max))
    -43.8 (-100 to 84)
    -26.6 (-100 to 176)
    Statistical analysis title
    		 Percent Change in Facial Inflammatory Lesion Count
    Statistical analysis description
    Analysis of secondary endpoints was based on the ITT Analysis Set using LOCF.
    Comparison groups
    Visonac cream with PDT v Vehicle cream and PDT
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean
    Point estimate
    -20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.2
         upper limit
    		 -6.8
    Notes
    [2] - Fixed terms for treatment and center and the baseline lesion count as covariate.

    Secondary: Percent change from baseline in facial non-inflammatory lesion counts

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    End point title
    		 Percent change from baseline in facial non-inflammatory lesion counts
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to 12 weeks after the first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: percent
        median (full range (min-max))
    -31.0 (-100 to 100)
    -37.0 (-100 to 196)
    Statistical analysis title
    		 Percent change in facial non-inflam. lesion counts
    Statistical analysis description
    Analysis of secondary endpoints was based on the ITT Analysis Set using LOCF.
    Comparison groups
    Visonac cream with PDT v Vehicle cream and PDT
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.72
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 11.3
    Notes
    [3] - Fixed terms for treatment and center and the baseline lesion count as covariate.

    Secondary: Number of Patients With Success According to IGA Scale Based on the Facial Assessment.

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    End point title
    		 Number of Patients With Success According to IGA Scale Based on the Facial Assessment.
    End point description
    The severity of acne was assessed at each visit using the 5-point IGA scale (0-4) 0 Clear; residual hyperpigmentation and erythema may be present 1 Almost clear; few scattered comedones and a few small papules 2 Mild; easily recognizable, less than half the face is involved. Some comedones and some papules and pustules 3 Moderate; more than half the face is involved. Many comedones, papules, and pustules. One nodule may be present 4 Severe; Most of face is involved, with comedones, numerous papules and pustules, and/or few nodules
    End point type
    Secondary
    End point timeframe
    From baseline to 12 weeks after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Subjects
    44
    14
    Statistical analysis title
    		 Treatment success on the IGA scale
    Statistical analysis description
    For categorical variables analyzed with logistic regression, treatment and center were included in the model.
    Comparison groups
    Visonac cream with PDT v Vehicle cream and PDT
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 8.1

    Secondary: IGA Clear or Almost Clear Scores based on the Facial Assessment:

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    End point title
    		 IGA Clear or Almost Clear Scores based on the Facial Assessment:
    End point description
    The severity of acne was assessed at each visit using the 5-point IGA scale (0-4) 0 Clear; residual hyperpigmentation and erythema may be present 1 Almost clear; few scattered comedones and a few small papules 2 Mild; easily recognizable, less than half the face is involved. Some comedones and some papules and pustules 3 Moderate; more than half the face is involved. Many comedones, papules, and pustules. One nodule may be present 4 Severe; Most of face is involved, with comedones, numerous papules and pustules, and/or few nodules
    End point type
    Secondary
    End point timeframe
    From baseline to 12 weeks after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Subjects
    13
    2
    Statistical analysis title
    		 IGA scale clear or almost clear
    Statistical analysis description
    Categorical efficacy endpoints were analyzed using logistic regression including terms for treatment and center.
    Comparison groups
    Visonac cream with PDT v Vehicle cream and PDT
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.094
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 19.9

    Secondary: Absolute change from baseline in facial non-inflammatory lesion count

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    End point title
    		 Absolute change from baseline in facial non-inflammatory lesion count
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to 12 weeks after the first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Lesions
        arithmetic mean (standard deviation)
    -11.8 ( 19.0 )
    -10.7 ( 22.1 )
    Statistical analysis title
    		 Absolute Change From Baseline in Facial Non-inflam
    Comparison groups
    Visonac cream with PDT v Vehicle cream and PDT
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.85
    Method
    		 ANCOVA
    Parameter type
    		 Least square means
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 5.5
    Notes
    [4] - Fixed terms for treatment and center and the baseline lesion count as covariate.

    Secondary: Absolute change in non-facial inflammatory lesion count

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    End point title
    		 Absolute change in non-facial inflammatory lesion count
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to 12 weeks after the first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    24
    15
    Units: Lesions
        arithmetic mean (standard deviation)
    -9.0 ( 9.8 )
    -4.1 ( 14.5 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in facial inflammatory lesion counts at week 2, 4 and 6

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    End point title
    		 Absolute change from baseline in facial inflammatory lesion counts at week 2, 4 and 6
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at 2, 4 and 6 weeks after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Lesion count
    arithmetic mean (standard deviation)
        Week 2
    -9.0 ( 14.9 )
    -4.4 ( 14.0 )
        Week 4
    -11.7 ( 18.3 )
    -6.5 ( 15.7 )
        Week 6
    -13.0 ( 19.0 )
    -6.2 ( 19.1 )
    No statistical analyses for this end point

    Other pre-specified: Pain during illumination

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    End point title
    		 Pain during illumination
    End point description
    Pain during illumination was assessed by the patient using a visual analogue scale (VAS) form 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
    End point type
    Other pre-specified
    End point timeframe
    Facial pain immediately after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: VAS score in cm
        median (full range (min-max))
    3.0 (0 to 8.8)
    0.1 (0 to 3.6)
    No statistical analyses for this end point

    Other pre-specified: Erythema score of mild and moderate

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    End point title
    		 Erythema score of mild and moderate
    End point description
    Clinical assessment of facial erythema using a 4-point rating scale (ranging from 0= none to 3=severe) before and after each illumination.
    End point type
    Other pre-specified
    End point timeframe
    Immediately after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Subjects
    86
    37
    No statistical analyses for this end point

    Other pre-specified: Erythema score of mild and moderate

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    End point title
    		 Erythema score of mild and moderate
    End point description
    Clinical assessment of facial erythema using a 4-point rating scale (ranging from 0= none to 3=severe) before and after each illumination.
    End point type
    Other pre-specified
    End point timeframe
    2 days after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Subjects
    65
    26
    No statistical analyses for this end point

    Other pre-specified: Erythema score of severe

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    End point title
    		 Erythema score of severe
    End point description
    Clinical assessment of facial erythema using a 4-point rating scale (ranging from 0= none to 3=severe) before and after each illumination.
    End point type
    Other pre-specified
    End point timeframe
    Immediately after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Subjects
    3
    0
    No statistical analyses for this end point

    Other pre-specified: Erythema score of severe

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    End point title
    		 Erythema score of severe
    End point description
    Clinical assessment of facial erythema using a 4-point rating scale (ranging from 0= none to 3=severe) before and after each illumination.
    End point type
    Other pre-specified
    End point timeframe
    2 days after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    100
    53
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Change in facial scarring

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    End point title
    		 Change in facial scarring
    End point description
    Clinical assessment using a 6 point scale; clear, almost clear, mild, moderate, severe, very severe. Patients who experienced a worsening of facial scarring score between Baseline and Week 12 with Visonac PDT compared with Vehicle PDT.
    End point type
    Other pre-specified
    End point timeframe
    Change from baseline to week 12 after first treatment
    End point values
    		 Visonac cream with PDT Vehicle cream and PDT
    Number of subjects analysed
    91
    46
    Units: Subjects
    19
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Visonac cream with PDT
    Reporting group description
    		 Visonac (MAL cream 80 mg/g), applied 1.5 hours under occlusion, before illumination with red ligth

    Reporting group title
    Vehicle cream with PDT
    Reporting group description
    		 Vehicle cream, applied 1.5 hours under occlusion, before illumination with red light

    Serious adverse events
    		 Visonac cream with PDT Vehicle cream with PDT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 53 (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: 1%
    Non-serious adverse events
    		 Visonac cream with PDT Vehicle cream with PDT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 100 (48.00%)
    14 / 53 (26.42%)
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Concussion
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 100 (3.00%)
    3 / 53 (5.66%)
         occurrences all number
    3
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 100 (3.00%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Vomiting
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Cough
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    17 / 100 (17.00%)
    0 / 53 (0.00%)
         occurrences all number
    32
    0
    Skin burning sensation
         subjects affected / exposed
    15 / 100 (15.00%)
    0 / 53 (0.00%)
         occurrences all number
    22
    0
    Pruritus
         subjects affected / exposed
    8 / 100 (8.00%)
    1 / 53 (1.89%)
         occurrences all number
    18
    1
    Erythema
         subjects affected / exposed
    4 / 100 (4.00%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Rash
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Scab
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Skin hyperpigmentation
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Swelling face
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Dermatitis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Skin mass
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 100 (3.00%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26663215
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