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    Clinical Trial Results:
    A Phase IIa, 28-day treatment, multicentre, randomised, comparator-controlled, observer-blind trial with intra-individual left/right comparison to investigate the anti-psoriatic efficacy and the safety of an LAS41004 formulation in comparison to an active reference in patients with mild to moderate plaque psoriasis

    Summary
    EudraCT number
    		 2013-003757-22
    Trial protocol
    		 DE  
    Global end of trial date
    13 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2016
    First version publication date
    25 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    H553000-1309
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02180464
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Almirall Hermal GmbH
    Sponsor organisation address
    Scholtzstraße 3, Reinbek, Germany, 21465
    Public contact
    Disclosure Central Team, ALMIRALL S.A., R&D@almirall.com
    Scientific contact
    Disclosure Central Team, ALMIRALL S.A., R&D@almirall.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
    13 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the anti-psoriatic efficacy and safety of the combination of LAS41004 (bexarotene plus betamethasone dipropionate) in a topical formulation by reference to Daivobet® ointment (calcipotriol plus betamethasone dipropionate)
    Protection of trial subjects
    The study was conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP) and applicable local regulatory requirements and laws. As such, screening assessments were performed after the patient had agreed to participate and had signed and dated the informed consent form, and safety and tolerability were evaluated throughout the study by monitoring of adverse events, performing laboratory tests and physical examinations, and measuring vital signs
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2014
    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
    Germany: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    36
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 30 ± 3 days prior to the first IMP administration (women) and up to 30 days prior to the first IMP administration (men), subjects underwent initial screening. Of 43 subjects screened, 3 subjects were not enrolled due to screen failure

    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
    		 LAS41004
    Arm description
    		 Once-daily topical application of LAS41004 (bexarotene 1% plus betamethasone dipropionate 0.064%) approximately 2–6 mg/cm2 to an area of 20–300 cm2
    Arm type
    		 Experimental

    Investigational medicinal product name
    LAS41004
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use , Cutaneous use
    Dosage and administration details
    Approximately 2 – 6 mg/cm2 of test product was applied by the patient to lesional areas (20–300 cm2) each, once daily without occlusion on 28 consecutive days. Each test product was applied once daily for a total of 28 days

    Arm title
    		 Daivobet
    Arm description
    		 Once-daily topical application of Daivobet (calcipotriol 0.05 mg/g plus betamethasone dipropionate 0.5 mg/g [BDP 0.643 mg/g]) approximately 2–6 mg/cm2 to an area of 20–300 cm2
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Daivobet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use, Topical use
    Dosage and administration details
    Approximately 2–6 mg/cm2 of test product was applied by the patient to lesional areas (20–300 cm2) each, once daily without occlusion on 28 consecutive days. Each test product was applied once daily for a total of 28 days

    Number of subjects in period 1
    		LAS41004 Daivobet
    Started
    40
    40
    Completed
    40
    40

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46 ± 14.2 -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 31 31

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    LAS41004
    Reporting group description
    		 Once-daily topical application of LAS41004 (bexarotene 1% plus betamethasone dipropionate 0.064%) approximately 2–6 mg/cm2 to an area of 20–300 cm2

    Reporting group title
    Daivobet
    Reporting group description
    		 Once-daily topical application of Daivobet (calcipotriol 0.05 mg/g plus betamethasone dipropionate 0.5 mg/g [BDP 0.643 mg/g]) approximately 2–6 mg/cm2 to an area of 20–300 cm2

    Primary: Change from baseline in total sign score on Day 29

    		 Close Top of page
    End point title
    		 Change from baseline in total sign score on Day 29
    End point description
    Total sign score (TSS) was defined as the sum of individual scores for erythema, scaling and infiltration using a 5-point scale (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = severest possible)
    End point type
    Primary
    End point timeframe
    Day 29
    End point values
    		 LAS41004 Daivobet
    Number of subjects analysed
    40
    40
    Units: unit(s)
        arithmetic mean (standard deviation)
    -4.2 ± 1.62
    -5.5 ± 1.32
    Statistical analysis title
    		 Day 29 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3

    Secondary: Change from baseline in total sign score

    		 Close Top of page
    End point title
    		 Change from baseline in total sign score
    End point description
    Total sign score (TSS) was defined as the sum of individual scores for erythema, scaling and infiltration using a 5-point scale (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = severest possible)
    End point type
    Secondary
    End point timeframe
    Up to day 29
    End point values
    		 LAS41004 Daivobet
    Number of subjects analysed
    40
    40
    Units: unit(s)
    arithmetic mean (standard deviation)
        Day 4
    -1.2 ± 1.08
    -1.8 ± 1.3
        Day 8
    -2.3 ± 1.52
    -3.4 ± 1.42
        Day 15
    -3.1 ± 1.55
    -4.4 ± 1.31
        Day 22
    -3.5 ± 1.6
    -5 ± 1.29
        Day 29
    -4.2 ± 1.62
    -5.5 ± 1.32
    Statistical analysis title
    		 Day 4 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0066
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Notes
    [1] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 8 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [2] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 15 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [3] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 22 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 2.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [4] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 29 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [5] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80

    Secondary: Change from baseline in erythema

    		 Close Top of page
    End point title
    		 Change from baseline in erythema
    End point description
    Individual scores for erythema, scaling and infiltration were assessed using a 5-point scale (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = severest possible)
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 LAS41004 Daivobet
    Number of subjects analysed
    40
    40
    Units: unit(s)/gram
    arithmetic mean (standard deviation)
        Day 4
    -0.2 ± 0.42
    -0.3 ± 0.46
        Day 8
    -0.5 ± 0.55
    -0.6 ± 0.5
        Day 15
    -0.7 ± 0.62
    -0.9 ± 0.62
        Day 22
    -0.8 ± 0.59
    -1.1 ± 0.69
        Day 29
    -1.1 ± 0.75
    -1.3 ± 0.57
    Statistical analysis title
    		 Day 4 LAS41004 v Daivobet
    Comparison groups
    Daivobet v LAS41004
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.3981
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [6] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 8 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.2461
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [7] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 15 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.0647
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [8] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 22 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.0159
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [9] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 29 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.0152
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [10] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80

    Secondary: Change from baseline in scaling

    		 Close Top of page
    End point title
    		 Change from baseline in scaling
    End point description
    Individual scores for erythema, scaling and infiltration were assessed using a 5-point scale (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = severest possible)
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 LAS41004 Daivobet
    Number of subjects analysed
    40
    40
    Units: unit(s)
    arithmetic mean (standard deviation)
        Day 4
    -0.6 ± 0.63
    -0.9 ± 0.61
        Day 8
    -1.1 ± 0.88
    -1.7 ± 0.89
        Day 15
    -1.4 ± 0.81
    -2 ± 0.66
        Day 22
    -1.5 ± 0.85
    -2.1 ± 0.69
        Day 29
    -1.7 ± 0.78
    -2.2 ± 0.75
    Statistical analysis title
    		 Day 4 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.0541
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [11] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 8 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [12] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 15 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Notes
    [13] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 22 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 < 0
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [14] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 29 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.0015
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [15] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80

    Secondary: Change from baseline in infiltration

    		 Close Top of page
    End point title
    		 Change from baseline in infiltration
    End point description
    Individual scores for erythema, scaling and infiltration were assessed using a 5-point scale (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = severest possible)
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 LAS41004 Daivobet
    Number of subjects analysed
    40
    40
    Units: unit(s)
    arithmetic mean (standard deviation)
        Day 4
    -0.3 ± 0.57
    -0.7 ± 0.74
        Day 8
    -0.8 ± 0.77
    -1.1 ± 0.86
        Day 15
    -1 ± 0.73
    -1.5 ± 0.82
        Day 22
    -1.2 ± 0.77
    -1.8 ± 0.7
        Day 29
    -1.5 ± 0.85
    -2 ± 0.78
    Statistical analysis title
    		 Day 4 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [16]
    P-value
    		 = 0.0021
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [16] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 8 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.0243
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [17] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 15 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 < 0
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Notes
    [18] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 22 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 < 0
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [19] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 29 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [20]
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13
    Notes
    [20] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80

    Secondary: Change from baseline in Physician's Global Assessment

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    End point title
    		 Change from baseline in Physician's Global Assessment
    End point description
    The overall clinical picture of psoriasis of the respective lesion was scored from severe to clear using a 6-point scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = moderate to severe, 5 = severe)
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 LAS41004 Daivobet
    Number of subjects analysed
    40
    40
    Units: unit(s)
    arithmetic mean (standard deviation)
        Day 4
    -0.4 ± 0.54
    -0.6 ± 0.6
        Day 8
    -0.7 ± 0.65
    -1 ± 0.68
        Day 15
    -1 ± 0.89
    -1.5 ± 0.68
        Day 22
    -1.1 ± 0.97
    -1.8 ± 0.8
        Day 29
    -1.5 ± 0.93
    -2 ± 0.8
    Statistical analysis title
    		 Day 4 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.1192
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [21] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 8 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [22]
    P-value
    		 = 0.0133
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [22] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 15 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.0028
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [23] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 22 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [24] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80
    Statistical analysis title
    		 Day 29 LAS41004 v Daivobet
    Comparison groups
    LAS41004 v Daivobet
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [25] - The number of participants in this analysis is automatically calculated by the database. The arms are not mutually exclusive and the number of patients in this analysis is 40, not 80

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 7 days after last study drug administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    LAS41004
    Reporting group description
    		 LAS41004 (bexarotene 1% plus betamethasone dipropionate 0.064% ) once-daily topical application of approximately 2-6 mg/cm2 to an area of 20-300 cm2

    Reporting group title
    Daivobet
    Reporting group description
    		 Once daily topical application of Daivobet (calcipotriol 0.05 mg/g plus betamethasone dipropionate 0.5 mg/g [BDP 0.643 mg/g]) approximately 2-6 mg/cm2 to an area of 20-300 cm2

    Serious adverse events
    		 LAS41004 Daivobet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (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: 2%
    Non-serious adverse events
    		 LAS41004 Daivobet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Apr 2014
    Amendment 1 was necessary due to conditions and advice noted by the BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte [German Federal Institute for Drugs and Medical Devices]) regarding stress and risks, inclusion and exclusion criteria, restrictions, manner of treatment, pregnancy test and measurement/assessment time points
    24 Apr 2014
    Amendment 2 was necessary due to new information regarding the analysis of stability for the LAS41004 formulation and a consequent correction of the corresponding storage conditions

    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
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