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    Clinical Trial Results:
    A psoriasis plaque test trial with LP0113 spray in patients with psoriasis vulgaris

    Summary
    EudraCT number
    2014-004759-30
    Trial protocol
    FR  
    Global end of trial date
    30 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jul 2016
    First version publication date
    09 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0113-1123
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02416258
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 45 44945888, ctr.disclosure@leo-pharma.com
    Scientific contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, 45 44945888, ctr.disclosure@leo-pharma.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
    30 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate (BDP) in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Apr 2015
    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
    France: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    38
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    50 subjects from 1 centre in France were enrolled into the trial. The first subject was enrolled on 02-Apr-2015 and the last subject completed the trial (last visit, including follow-up) on 30-Jun-2015.

    Pre-assignment
    Screening details
    Screening assessments could occur up to 28 days prior to the Day 1 Visit (Visit 2; hereafter “Baseline”). At the Screening Visit, 1 to 6 lesions (“target plaques”) were identified on the arms, legs and/or trunk of the subject and monitored until the Baseline Visit when the 6 test sites to be treated with IMP were identified. No screening failures.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [1]
    Blinding implementation details
    Due to the different formulations of some of the IMPs (foam, spray, gel), a fully double blinded design was not possible and the trial was performed as an investigator-blinded trial.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    LP0113 aerosol spray
    Arm description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. LP0113 aerosol spray contains calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g.
    Arm type
    Experimental

    Investigational medicinal product name
    LP0113 aerosol spray
    Investigational medicinal product code
    LP0113
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    LP0113, LEO 90100, BDP in aerosol spray vehicle, calcipotriol in aerosol spray vehicle, and the aerosol spray vehicle were sprayed on the test sites and gently rubbed into the skin using a gloved finger (1 finger for each product). Each test site was treated with 50 mg degassed spray or foam. Finally, all test sites were covered with a non-occlusive gauze maintained with an hypoallergenic dressing. At visits which only included application of IMPs, the non-occlusive gauze was removed from the test sites using a small pair of scissors. IMPs were then applied as described above and new non-occlusive gauze was applied to the test sites and attached using a hypoallergenic dressing. At visits which included both application of IMPs and clinical assessments, the non-occlusive gauze and the circular devices were removed prior to the assessments by the blinded investigator; following the assessments, the circular devices were replaced with new ones and IMPs were applied as described above.

    Arm title
    Daivobet® gel
    Arm description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. Daivobet® gel contains calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g.
    Arm type
    Active comparator

    Investigational medicinal product name
    Daivobet® gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Daivobet® gel was applied using an Eppendorf combitip® (50 μl per application). Finally, all test sites were covered with a non-occlusive gauze maintained with an hypoallergenic dressing. At visits which only included application of IMPs, the non-occlusive gauze was removed from the test sites using a small pair of scissors. IMPs were then applied as described above and new non-occlusive gauze was applied to the test sites and attached using a hypoallergenic dressing. At visits which included both application of IMPs and clinical assessments, the non-occlusive gauze and the circular devices were removed prior to the assessments by the blinded investigator; following the assessments, the circular devices were replaced with new ones and IMPs were applied as described above.

    Arm title
    LEO 90100
    Arm description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. LEO 90100 contains calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g.
    Arm type
    Active comparator

    Investigational medicinal product name
    LEO 90100
    Investigational medicinal product code
    LEO 90100
    Other name
    Enstilar® foam
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    LP0113, LEO 90100, BDP in aerosol spray vehicle, calcipotriol in aerosol spray vehicle, and the aerosol spray vehicle were sprayed on the test sites and gently rubbed into the skin using a gloved finger (1 finger for each product). Each test site was treated with 50 mg degassed spray or foam. Finally, all test sites were covered with a non-occlusive gauze maintained with an hypoallergenic dressing. At visits which only included application of IMPs, the non-occlusive gauze was removed from the test sites using a small pair of scissors. IMPs were then applied as described above and new non-occlusive gauze was applied to the test sites and attached using a hypoallergenic dressing. At visits which included both application of IMPs and clinical assessments, the non-occlusive gauze and the circular devices were removed prior to the assessments by the blinded investigator; following the assessments, the circular devices were replaced with new ones and IMPs were applied as described above.

    Arm title
    BDP aerosol spray
    Arm description
    Betamethasone dipropionate (BDP) in aerosol spray vehicle Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. BDP in aerosol spray contains betamethasone (as dipropionate) 0.5 mg/g.
    Arm type
    Active comparator

    Investigational medicinal product name
    BDP aerosol spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    LP0113, LEO 90100, BDP in aerosol spray vehicle, calcipotriol in aerosol spray vehicle, and the aerosol spray vehicle were sprayed on the test sites and gently rubbed into the skin using a gloved finger (1 finger for each product). Each test site was treated with 50 mg degassed spray or foam. Finally, all test sites were covered with a non-occlusive gauze maintained with an hypoallergenic dressing. At visits which only included application of IMPs, the non-occlusive gauze was removed from the test sites using a small pair of scissors. IMPs were then applied as described above and new non-occlusive gauze was applied to the test sites and attached using a hypoallergenic dressing. At visits which included both application of IMPs and clinical assessments, the non-occlusive gauze and the circular devices were removed prior to the assessments by the blinded investigator; following the assessments, the circular devices were replaced with new ones and IMPs were applied as described above.

    Arm title
    Calcipotriol aerosol spray
    Arm description
    Calcipotriol in aerosol spray vehicle Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. Calcipotriol in aerosol spray contains calcipotriol (as monohydrate) 50 mcg/g
    Arm type
    Active comparator

    Investigational medicinal product name
    Calcipotriol aerosol spray
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    LP0113, LEO 90100, BDP in aerosol spray vehicle, calcipotriol in aerosol spray vehicle, and the aerosol spray vehicle were sprayed on the test sites and gently rubbed into the skin using a gloved finger (1 finger for each product). Each test site was treated with 50 mg degassed spray or foam. Finally, all test sites were covered with a non-occlusive gauze maintained with an hypoallergenic dressing. At visits which only included application of IMPs, the non-occlusive gauze was removed from the test sites using a small pair of scissors. IMPs were then applied as described above and new non-occlusive gauze was applied to the test sites and attached using a hypoallergenic dressing. At visits which included both application of IMPs and clinical assessments, the non-occlusive gauze and the circular devices were removed prior to the assessments by the blinded investigator; following the assessments, the circular devices were replaced with new ones and IMPs were applied as described above.

    Arm title
    Aerosol spray vehicle
    Arm description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration.
    Arm type
    Placebo

    Investigational medicinal product name
    Aerosol spray vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    LP0113, LEO 90100, BDP in aerosol spray vehicle, calcipotriol in aerosol spray vehicle, and the aerosol spray vehicle were sprayed on the test sites and gently rubbed into the skin using a gloved finger (1 finger for each product). Each test site was treated with 50 mg degassed spray or foam. Finally, all test sites were covered with a non-occlusive gauze maintained with an hypoallergenic dressing. At visits which only included application of IMPs, the non-occlusive gauze was removed from the test sites using a small pair of scissors. IMPs were then applied as described above and new non-occlusive gauze was applied to the test sites and attached using a hypoallergenic dressing. At visits which included both application of IMPs and clinical assessments, the non-occlusive gauze and the circular devices were removed prior to the assessments by the blinded investigator; following the assessments, the circular devices were replaced with new ones and IMPs were applied as described above.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the different formulations of some of the IMPs (foam, spray, gel), a fully double blinded design was not possible and the trial was performed as an investigator-blinded trial.
    Number of subjects in period 1
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Started
    50
    50
    50
    50
    50
    50
    Completed
    50
    50
    50
    50
    50
    50

    Baseline characteristics

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

    Reporting group values
    Overall trial Total
    Number of subjects
    50 50
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    38 38
        From 65-84 years
    12 12
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.3 ± 13.6 -
    Gender categorical
    Units: Subjects
        Female
    21 21
        Male
    29 29

    End points

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    End points reporting groups
    Reporting group title
    LP0113 aerosol spray
    Reporting group description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. LP0113 aerosol spray contains calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g.

    Reporting group title
    Daivobet® gel
    Reporting group description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. Daivobet® gel contains calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g.

    Reporting group title
    LEO 90100
    Reporting group description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. LEO 90100 contains calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g.

    Reporting group title
    BDP aerosol spray
    Reporting group description
    Betamethasone dipropionate (BDP) in aerosol spray vehicle Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. BDP in aerosol spray contains betamethasone (as dipropionate) 0.5 mg/g.

    Reporting group title
    Calcipotriol aerosol spray
    Reporting group description
    Calcipotriol in aerosol spray vehicle Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration. Calcipotriol in aerosol spray contains calcipotriol (as monohydrate) 50 mcg/g

    Reporting group title
    Aerosol spray vehicle
    Reporting group description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration.

    Primary: Absolute Change in Total Clinical Score of Clinical Signs at End of Treatment Compared to Baseline

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    End point title
    Absolute Change in Total Clinical Score of Clinical Signs at End of Treatment Compared to Baseline
    End point description
    The severity of the clinical signs erythema, scaling, and infiltration was assessed on a 7-point scale ranging from 0 (no evidence) to 3 (severe) [0, 0.5, 1, 1.5, 2, 2.5, 3]. The Total Clinical Score (TCS) was obtained by summing the scores for erythema, scaling, and infiltration and could range from 0 to 9. Treatment differences were tested as contrasts using a two-way ANOVA with treatment and subject as fixed effects. As the purpose of this trial was to obtain preliminary clinical estimates of effect, no correction to multiplicity was made in the primary analysis. A secondary analysis using Tukey’s honestly significant difference (HSD) method for correcting p-values was produced in the two-way ANOVA.
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: Total Clinical Score
    arithmetic mean (standard deviation)
        Baseline
    6.5 ± 0.8
    6.5 ± 0.8
    6.4 ± 0.8
    6.4 ± 0.8
    6.4 ± 0.8
    6.4 ± 0.8
        Day 29 (Change from Baseline)
    -5.4 ± 1.3
    -5 ± 1.6
    -5.9 ± 0.8
    -5.2 ± 1.3
    -3.1 ± 1.9
    -1.6 ± 1.5
    Statistical analysis title
    TCS comparison LP0113 vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LP0113 aerosol spray v Aerosol spray vehicle
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [1]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -3.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    -3.32
    Notes
    [1] - Statistically significant superiority of LP0113 aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison Daivobet vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [2]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -3.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.91
         upper limit
    -2.93
    Notes
    [2] - Statistically significant superiority of Daivobet® gel over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison LEO 90100 vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LEO 90100 - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [3]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -4.36
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.85
         upper limit
    -3.87
    Notes
    [3] - Statistically significant superiority of LEO 90100 over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison BDP vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (BDP aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [4]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -3.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.13
         upper limit
    -3.15
    Notes
    [4] - Statistically significant superiority of BDP aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison Calcipotriol vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Calcipotriol aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Calcipotriol aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [5]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -1.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.02
         upper limit
    -1.04
    Notes
    [5] - Statistically significant superiority of Calcipotriol aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison LP0113 vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -2.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.77
         upper limit
    -1.79
    Notes
    [6] - Statistically significant superiority of LP0113 aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison Daivobet vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [7]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -1.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.38
         upper limit
    -1.4
    Notes
    [7] - Statistically significant superiority of Daivobet® gel over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison LEO 90100 vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LEO 90100 - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [8]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -2.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.32
         upper limit
    -2.34
    Notes
    [8] - Statistically significant superiority of LEO 90100 over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison BDP vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (BDP aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -2.11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.6
         upper limit
    -1.62
    Notes
    [9] - Statistically significant superiority of BDP aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison LP0113 vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.66
         upper limit
    0.32
    Statistical analysis title
    TCS comparison Daivobet vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.38
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.27
         upper limit
    0.71
    Statistical analysis title
    TCS comparison LEO 90100 vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LEO 90100 - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004 [10]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.21
         upper limit
    -0.23
    Notes
    [10] - Statistically significant superiority of LEO 90100 over BDP aerosol spray
    Statistical analysis title
    TCS comparison LP0113 vs LEO 90100
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.028 [11]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.06
         upper limit
    1.04
    Notes
    [11] - Statistically significant superiority of LEO 90100 over LP0113 aerosol spray
    Statistical analysis title
    TCS comparison Daivobet vs LEO 90100
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [12]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.45
         upper limit
    1.43
    Notes
    [12] - Statistically significant superiority of LEO 90100 over Daivobet® gel
    Statistical analysis title
    TCS comparison LP0113 vs Daivobet
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - Daivobet® gel). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Daivobet® gel v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.12
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.39
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.88
         upper limit
    0.1
    Statistical analysis title
    TCS comparison LP0113 vs Vehicle - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - Vehicle aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LP0113 aerosol spray v Aerosol spray vehicle
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [13]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.53
         upper limit
    -3.09
    Notes
    [13] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of LP0113 aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison Daivobet vs Vehicle - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - Vehicle aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [14]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.14
         upper limit
    -2.7
    Notes
    [14] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of Daivobet® gel over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison LEO 90100 vs Vehicle - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LEO 90100 - Vehicle aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [15]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.08
         upper limit
    -3.64
    Notes
    [15] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of LEO 90100 over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison Calcipotriol vs Vehicle - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Calcipotriol aerosol spray - Vehicle aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Calcipotriol aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [16]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.25
         upper limit
    -0.81
    Notes
    [16] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of Calcipotriol aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison LP0113 vs Calcipotriol - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [17]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    -1.56
    Notes
    [17] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of LP0113 aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison BDP vs Vehicle - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (BDP aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [18]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.36
         upper limit
    -2.92
    Notes
    [18] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of BDP aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    TCS comparison Daivobet vs Calcipotriol - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [19]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.61
         upper limit
    -1.17
    Notes
    [19] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of Daivobet® gel over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison LEO 90100 vs Calcipotriol - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LEO 90100 - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [20]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.55
         upper limit
    -2.11
    Notes
    [20] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of LEO 90100 over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison BDP vs Calcipotriol - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (BDP aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [21]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.83
         upper limit
    -1.39
    Notes
    [21] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of BDP aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    TCS comparison LP0113 vs BDP - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.98 [22]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.89
         upper limit
    0.55
    Notes
    [22] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method.
    Statistical analysis title
    TCS comparison Daivobet vs BDP - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.95 [23]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    0.94
    Notes
    [23] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method.
    Statistical analysis title
    TCS comparison LEO 90100 vs BDP - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LEO 90100 - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.048 [24]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.44
         upper limit
    0
    Notes
    [24] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of LEO 90100 over BDP aerosol spray
    Statistical analysis title
    TCS comparison LP0113 vs LEO 90100 - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.24 [25]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.17
         upper limit
    1.27
    Notes
    [25] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method.
    Statistical analysis title
    TCS comparison Daivobet vs LEO 90100 - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (Daivobet® gel - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003 [26]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.22
         upper limit
    1.66
    Notes
    [26] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method. Statistically significant superiority of LEO 90100 over Daivobet® gel
    Statistical analysis title
    TCS comparison LP0113 vs Daivobet - Tukey
    Statistical analysis description
    Between treatment difference in absolute change in TCS from baseline to end of treatment (LP0113 aerosol spray - Daivobet® gel). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Daivobet® gel v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.62 [27]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.11
         upper limit
    0.33
    Notes
    [27] - Corrected P-values and confidence intervals using Tukeys honestly significant difference method.

    Secondary: Absolute Change in Total Clinical Score at Individual Visits Compared to Baseline

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    End point title
    Absolute Change in Total Clinical Score at Individual Visits Compared to Baseline
    End point description
    Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling, and infiltration) could range from 0 to 9.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: Total Clinical Score
    arithmetic mean (standard deviation)
        Baseline
    6.5 ± 0.8
    6.5 ± 0.8
    6.4 ± 0.8
    6.4 ± 0.7
    6.4 ± 0.7
    6.4 ± 0.8
        Day 4 (Change from Baseline)
    -0.9 ± 1.2
    -1 ± 1.1
    -1.6 ± 1.5
    -0.8 ± 1.1
    -0.3 ± 0.8
    -0.4 ± 0.7
        Day 8 (Change from Baseline)
    -2.5 ± 1.5
    -2.1 ± 1.3
    -3.1 ± 1.3
    -2 ± 1.5
    -0.9 ± 1.1
    -0.5 ± 1
        Day 11 (Change from Baseline)
    -3.5 ± 1.8
    -3 ± 1.3
    -4.1 ± 1.3
    -3 ± 1.8
    -1.4 ± 1.1
    -1 ± 1.1
        Day 15 (Change from Baseline)
    -4.2 ± 1.7
    -3.6 ± 1.5
    -4.8 ± 1.1
    -3.6 ± 1.9
    -2 ± 1.4
    -1.1 ± 1.2
        Day 18 (Change from Baseline)
    -4.7 ± 1.4
    -4.3 ± 1.6
    -5.3 ± 1.1
    -4.3 ± 1.7
    -2.4 ± 1.5
    -1.4 ± 1.3
        Day 22 (Change from Baseline)
    -4.9 ± 1.4
    -4.5 ± 1.7
    -5.5 ± 1
    -4.8 ± 1.4
    -2.6 ± 1.4
    -1.2 ± 1.4
        Day 25 (Change from Baseline)
    -5.2 ± 1.3
    -4.9 ± 1.6
    -4.9 ± 1.6
    -5 ± 1.3
    -2.8 ± 1.5
    -1.5 ± 1.4
        Day 29 (Change from Baseline)
    -5.4 ± 1.3
    -5 ± 1.6
    -5.9 ± 0.8
    -5.2 ± 1.3
    -3.1 ± 1.9
    -1.6 ± 1.5
    No statistical analyses for this end point

    Secondary: Absolute Change in Score of The Clinical Sign Erythema at Individual Visits Compared to Baseline

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    End point title
    Absolute Change in Score of The Clinical Sign Erythema at Individual Visits Compared to Baseline
    End point description
    Erythema Score could range from 0 (no evidence) to 3 (severe) on a 7 point scale [0, 0.5, 1, 1.5, 2, 2.5, 3]. Erythema is one of three clinical scores (erythema, scaling, and infiltration) the sum of which equals the Total Clinical Score (range 0 to 9).
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: Erythema Score
    arithmetic mean (standard deviation)
        Baseline
    2.3 ± 0.3
    2.3 ± 0.3
    2.3 ± 0.3
    2.3 ± 0.3
    2.3 ± 0.3
    2.3 ± 0.3
        Day 4 (Change from Baseline)
    -0.4 ± 0.4
    -0.4 ± 0.5
    -0.7 ± 0.5
    -0.4 ± 0.5
    -0.1 ± 0.3
    -0.2 ± 0.3
        Day 8 (Change from Baseline)
    -0.8 ± 0.5
    -0.8 ± 0.5
    -1.1 ± 0.5
    -0.8 ± 0.6
    -0.3 ± 0.4
    -0.3 ± 0.4
        Day 11 (Change from Baseline)
    -1.1 ± 0.7
    -1.1 ± 0.5
    -1.4 ± 0.6
    -1.1 ± 0.6
    -0.5 ± 0.4
    -0.3 ± 0.5
        Day 15 (Change from Baseline)
    -1.3 ± 0.6
    -1.2 ± 0.5
    -1.5 ± 0.6
    -1.2 ± 0.7
    -0.7 ± 0.5
    -0.4 ± 0.5
        Day 18 (Change from Baseline)
    -1.5 ± 0.6
    -1.5 ± 0.6
    -1.7 ± 0.7
    -1.5 ± 0.7
    -0.8 ± 0.5
    -0.5 ± 0.6
        Day 22 (Change from Baseline)
    -1.5 ± 0.6
    -1.4 ± 0.7
    -1.7 ± 0.6
    -1.6 ± 0.5
    -0.9 ± 0.5
    -0.4 ± 0.6
        Day 25 (Change from Baseline)
    -1.7 ± 0.6
    -1.6 ± 0.6
    -1.9 ± 0.6
    -1.8 ± 0.5
    -1 ± 0.5
    -0.6 ± 0.6
        Day 29 (Change from Baseline)
    -1.8 ± 0.6
    -1.7 ± 0.6
    -2 ± 0.5
    -1.8 ± 0.5
    -1.1 ± 0.7
    -0.6 ± 0.6
    No statistical analyses for this end point

    Secondary: Absolute Change in Score of The Clinical Sign Scaling at Individual Visits Compared to Baseline

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    End point title
    Absolute Change in Score of The Clinical Sign Scaling at Individual Visits Compared to Baseline
    End point description
    Scaling Score could range from 0 (no evidence) to 3 (severe) on a 7 point scale [0, 0.5, 1, 1.5, 2, 2.5, 3]. Scaling is one of three clinical scores (erythema, scaling, and infiltration) the sum of which equals the Total Clinical Score (range 0 to 9).
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: Scaling Score
    arithmetic mean (standard deviation)
        Baseling
    2.1 ± 0.4
    2 ± 0.4
    2 ± 0.4
    2 ± 0.4
    2 ± 0.4
    2 ± 0.4
        Day 4 (Change from Baseline)
    -0.3 ± 0.5
    -0.4 ± 0.5
    -0.5 ± 0.6
    -0.2 ± 0.4
    -0.1 ± 0.4
    -0.1 ± 0.4
        Day 8 (Change from Baseline)
    -0.9 ± 0.6
    -0.8 ± 0.6
    -1.1 ± 0.6
    -0.7 ± 0.7
    -0.3 ± 0.5
    -0.1 ± 0.5
        Day 11 (Change from Baseline)
    -1.2 ± 0.7
    -1.1 ± 0.5
    -1.5 ± 0.6
    -1 ± 0.7
    -0.5 ± 0.5
    -0.4 ± 0.6
        Day 15 (Change from Baseline)
    -1.5 ± 0.7
    -1.3 ± 0.6
    -1.7 ± 0.5
    -1.2 ± 0.7
    -0.7 ± 0.6
    -0.3 ± 0.5
        Day 18 (Change from Baseline)
    -1.6 ± 0.6
    -1.5 ± 0.6
    -1.9 ± 0.5
    -1.4 ± 0.6
    -0.8 ± 0.6
    -0.5 ± 0.5
        Day 22 (Change from Baseline)
    -1.7 ± 0.5
    -1.6 ± 0.7
    -1.9 ± 0.5
    -1.6 ± 0.6
    -0.9 ± 0.5
    -0.4 ± 0.6
        Day 25 (Change from Baseline)
    -1.8 ± 0.5
    -1.7 ± 0.6
    -1.9 ± 0.5
    -1.7 ± 0.5
    -1 ± 0.6
    -0.5 ± 0.6
        Day 29 (Change from Baseline)
    -1.8 ± 0.5
    -1.7 ± 0.6
    -2 ± 0.4
    -1.7 ± 0.5
    -1.1 ± 0.7
    -0.6 ± 0.7
    No statistical analyses for this end point

    Secondary: Absolute Change in Score of The Clinical Sign Infiltration at Individual Visits Compared to Baseline

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    End point title
    Absolute Change in Score of The Clinical Sign Infiltration at Individual Visits Compared to Baseline
    End point description
    Infiltration Score could range from 0 (no evidence) to 3 (severe) on a 7 point scale [0, 0.5, 1, 1.5, 2, 2.5, 3]. Infiltration is one of three clinical scores (erythema, scaling, and infiltration) the sum of which equals the Total Clinical Score (range 0 to 9).
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: Infiltration Score
    arithmetic mean (standard deviation)
        Baseline
    2.1 ± 0.3
    2.1 ± 0.3
    2.1 ± 0.3
    2.1 ± 0.3
    2.1 ± 0.3
    2.1 ± 0.3
        Day 4 (Change from Baseline)
    -0.3 ± 0.5
    -0.2 ± 0.4
    -0.4 ± 0.5
    -0.2 ± 0.5
    -0.1 ± 0.4
    -0.1 ± 0.3
        Day 8 (Change from Baseline)
    -0.8 ± 0.6
    -0.6 ± 0.5
    -0.9 ± 0.5
    -0.5 ± 0.5
    -0.3 ± 0.4
    -0.1 ± 0.4
        Day 11 (Change from Baseline)
    -1.2 ± 0.7
    -0.9 ± 0.5
    -1.3 ± 0.6
    -0.9 ± 0.6
    -0.4 ± 0.5
    -0.3 ± 0.4
        Day 15 (Change from Baseline)
    -1.5 ± 0.6
    -1.2 ± 0.7
    -1.6 ± 0.5
    -1.2 ± 0.7
    -0.7 ± 0.6
    -0.3 ± 0.5
        Day 18 (Change from Baseline)
    -1.6 ± 0.5
    -1.4 ± 0.7
    -1.8 ± 0.5
    -1.4 ± 0.7
    -0.8 ± 0.6
    -0.4 ± 0.5
        Day 22 (Change from Baseline)
    -1.7 ± 0.5
    -1.5 ± 0.7
    -1.9 ± 0.4
    -1.5 ± 0.6
    -0.8 ± 0.6
    -0.3 ± 0.4
        Day 25 (Change from Baseline)
    -1.7 ± 0.5
    -1.6 ± 0.6
    -2 ± 0.3
    -1.6 ± 0.5
    -0.9 ± 0.6
    -0.4 ± 0.5
        Day 29 (Change from Baseline)
    -1.8 ± 0.5
    -1.6 ± 0.6
    -2 ± 0.3
    -1.7 ± 0.4
    -1 ± 0.7
    -0.4 ± 0.5
    No statistical analyses for this end point

    Secondary: Absolute Change in Total Skin Thickness at End of Treatment Compared to Baseline

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    End point title
    Absolute Change in Total Skin Thickness at End of Treatment Compared to Baseline
    End point description
    The skin thickness of each test site was measured at Baseline and Day 29 using an ultrasound scanner. Data were analysed with a special software (Dermavision 2D, Cortex Technology). Compared to non-psoriatic skin, the ultrasound image of a psoriatic plaque is characterized by an increased skin thickness and by the presence of a so-called echo-poor band just below the skin surface. The thickness of this echo-poor band is an indication of the degree of acanthosis, papillomatosis and infiltration in the upper dermis. Three scans were recorded per test site at each time point. At the end of the trial, these images were analysed by a blinded assessor at the trial site who recorded the following for each image: - Total skin thickness (in millimetres) - Echo-poor band thickness (in millimetres) Treatment differences were tested as contrasts using a two-way ANOVA with treatment and subject as fixed effects.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: millimeters (mm)
    arithmetic mean (standard deviation)
        Baseline
    2.4 ± 0.4
    2.4 ± 0.4
    2.4 ± 0.5
    2.4 ± 0.4
    2.4 ± 0.4
    2.4 ± 0.4
        Day 29 (Change from Baseline)
    -1 ± 0.4
    -0.9 ± 0.4
    -1 ± 0.4
    -1 ± 0.3
    -0.5 ± 0.5
    -0.2 ± 0.4
    Statistical analysis title
    Skin Thickness comparison LP0113 vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LP0113 aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LP0113 aerosol spray v Aerosol spray vehicle
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [28]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.95
         upper limit
    -0.68
    Notes
    [28] - Statistically significant superiority of LP0113 aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    Skin Thickness comparison Daivobet vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (Daivobet® gel - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [29]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.88
         upper limit
    -0.61
    Notes
    [29] - Statistically significant superiority of Daivobet® gel over Aerosol spray vehicle
    Statistical analysis title
    Skin Thickness comparison LEO 90100 vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LEO 90100 - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [30]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.02
         upper limit
    -0.75
    Notes
    [30] - Statistically significant superiority of LEO 90100 over Aerosol spray vehicle
    Statistical analysis title
    Skin Thickness comparison BDP vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (BDP aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [31]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.95
         upper limit
    -0.68
    Notes
    [31] - Statistically significant superiority of BDP aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    Skin Thickness comparison Calcipotriol vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (Calcipotriol aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Calcipotriol aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [32]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.46
         upper limit
    -0.19
    Notes
    [32] - Statistically significant superiority of Calcipotriol aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    Skin Thickness comparison LP0113 vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LP0113 aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [33]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.62
         upper limit
    -0.35
    Notes
    [33] - Statistically significant superiority of LP0113 aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    Skin Thickness comparison Daivobet vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (Daivobet® gel - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [34]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.55
         upper limit
    -0.28
    Notes
    [34] - Statistically significant superiority of Daivobet® gel over Calcipotriol aerosol spray
    Statistical analysis title
    Skin Thickness comparison LEO90100 vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LEO 90100 - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [35]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.69
         upper limit
    -0.42
    Notes
    [35] - Statistically significant superiority of LEO 90100 over Calcipotriol aerosol spray
    Statistical analysis title
    Skin Thickness comparison BDP vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (BDP aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [36]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.62
         upper limit
    -0.35
    Notes
    [36] - Statistically significant superiority of BDP aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    Skin Thickness comparison LP0113 vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LP0113 aerosol spray - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.95
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.14
         upper limit
    0.13
    Statistical analysis title
    Skin Thickness comparison Daivobet vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (Daivobet® gel - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.32
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.07
         upper limit
    0.2
    Statistical analysis title
    Skin Thickness comparison LEO 90100 vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LEO 90100 - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.32
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    0.07
    Statistical analysis title
    Skin Thickness comparison LP0113 vs LEO 90100
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LP0113 aerosol spray - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.07
         upper limit
    0.2
    Statistical analysis title
    Skin Thickness comparison Daivobet vs LEO 90100
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (Daivobet® gel - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.047 [37]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0.27
    Notes
    [37] - Statistically significant superiority of LEO 90100 over Daivobet® gel
    Statistical analysis title
    Skin Thickness comparison LP0113 vs Daivobet
    Statistical analysis description
    Between treatment difference in absolute change in total skin thickness from baseline to end of treatment (LP0113 aerosol spray - Daivobet® gel). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Daivobet® gel v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.29
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.21
         upper limit
    0.06

    Secondary: Absolute Change in Echo-poor Band Thickness at End of Treatment Compared to Baseline

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    End point title
    Absolute Change in Echo-poor Band Thickness at End of Treatment Compared to Baseline
    End point description
    The skin thickness of each test site was measured at Baseline and Day 29 using an ultrasound scanner. Data were analysed with a special software (Dermavision 2D, Cortex Technology). Compared to non-psoriatic skin, the ultrasound image of a psoriatic plaque is characterized by an increased skin thickness and by the presence of a so-called echo-poor band just below the skin surface. The thickness of this echo-poor band is an indication of the degree of acanthosis, papillomatosis and infiltration in the upper dermis. Three scans were recorded per test site at each time point. At the end of the trial, these images were analysed by a blinded assessor at the trial site who recorded the following for each image: - Total skin thickness (in millimetres) - Echo-poor band thickness (in millimetres) Treatment differences were tested as contrasts using a two-way ANOVA with treatment and subject as fixed effects.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    LP0113 aerosol spray Daivobet® gel LEO 90100 BDP aerosol spray Calcipotriol aerosol spray Aerosol spray vehicle
    Number of subjects analysed
    50
    50
    50
    50
    50
    50
    Units: millimeters (mm)
    arithmetic mean (standard deviation)
        Baseline
    1.2 ± 0.5
    1.2 ± 0.5
    1.2 ± 0.6
    1.2 ± 0.4
    1.1 ± 0.5
    1.2 ± 0.5
        Day 29 (Change from Baseline)
    -1.1 ± 0.4
    -1 ± 0.6
    -1.1 ± 0.5
    -1 ± 0.4
    -0.5 ± 0.6
    -0.2 ± 0.6
    Statistical analysis title
    Echo-poor Band comparison LP0113 vs. Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LP0113 aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LP0113 aerosol spray v Aerosol spray vehicle
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [38]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.03
         upper limit
    -0.68
    Notes
    [38] - Statistically significant superiority of LP0113 aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    Echo-poor Band comparison Daivobet vs. Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (Daivobet® gel - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [39]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.94
         upper limit
    -0.59
    Notes
    [39] - Statistically significant superiority of Daivobet® gel over Aerosol spray vehicle
    Statistical analysis title
    Echo-poor Band comparison LEO 90100 vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LEO 90100 - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [40]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.09
         upper limit
    -0.74
    Notes
    [40] - Statistically significant superiority of LEO 90100 over Aerosol spray vehicle
    Statistical analysis title
    Echo-poor Band comparison BDP vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (BDP aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [41]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.99
         upper limit
    -0.64
    Notes
    [41] - Statistically significant superiority of BDP aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    Echo-poor Band comparison Calcipotriol vs Vehicle
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (Calcipotriol aerosol spray - Aerosol spray vehicle). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Aerosol spray vehicle v Calcipotriol aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [42]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.31
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.49
         upper limit
    -0.14
    Notes
    [42] - Statistically significant superiority of Calcipotriol aerosol spray over Aerosol spray vehicle
    Statistical analysis title
    Echo-poor Band comparison LP0113 vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LP0113 aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [43]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.72
         upper limit
    -0.37
    Notes
    [43] - Statistically significant superiority of LP0113 aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    Echo-poor Band comparison Daivobet vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (Daivobet® gel - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [44]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.45
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.62
         upper limit
    -0.27
    Notes
    [44] - Statistically significant superiority of Daivobet® gel over Calcipotriol aerosol spray
    Statistical analysis title
    Echo-poor Band comparison LEO90100 vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LEO 90100 - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [45]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    -0.43
    Notes
    [45] - Statistically significant superiority of LEO 90100 over Calcipotriol aerosol spray
    Statistical analysis title
    Echo-poor Band comparison BDP vs Calcipotriol
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (BDP aerosol spray - Calcipotriol aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Calcipotriol aerosol spray v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [46]
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.67
         upper limit
    -0.33
    Notes
    [46] - Statistically significant superiority of BDP aerosol spray over Calcipotriol aerosol spray
    Statistical analysis title
    Echo-poor Band comparison LP0113 vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LP0113 aerosol spray - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LP0113 aerosol spray v BDP aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.62
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.22
         upper limit
    0.13
    Statistical analysis title
    Echo-poor Band comparison Daivobet vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (Daivobet® gel - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.56
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.23
    Statistical analysis title
    Echo-poor Band comparison LEO 90100 vs BDP
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LEO 90100 - BDP aerosol spray). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    BDP aerosol spray v LEO 90100
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.26
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.27
         upper limit
    0.07
    Statistical analysis title
    Echo-poor Band comparison LP0113 vs LEO 90100
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LP0113 aerosol spray - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.52
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.23
    Statistical analysis title
    Echo-poor Band comparison Daivobet vs LEO 90100
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (Daivobet® gel - LEO 90100). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    LEO 90100 v Daivobet® gel
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.086
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.02
         upper limit
    0.33
    Statistical analysis title
    Echo-poor Band comparison LP0113 vs Daivobet
    Statistical analysis description
    Between treatment difference in absolute change in Echo-poor band thickness from baseline to end of treatment (LP0113 aerosol spray - Daivobet® gel). Treatment comparisons using ANOVA with treatment and subject as factors. Same subjects receiving both treatments applied to different test sites.
    Comparison groups
    Daivobet® gel v LP0113 aerosol spray
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.28
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.27
         upper limit
    0.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 weeks
    Adverse event reporting additional description
    No cutaneous AEs were observed and none of the AEs were assessed by the investigator to be related to the trial treatments. AEs are reported as one safety population for all IMP since all subjects were exposed to all IMPs at the same time. A total of 18 subjects (36.0%) experienced a total of 25 AEs after start of treatment with IMPs.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    Each subject was treated with the 6 products on 6 test sites (each 5 cm2) which were located within 1 to 6 stable psoriasis lesions (target plaques) on arms, legs and/or trunk. An application scheme showed which treatment should be applied to each test site. The test sites were marked with a numbered, disposable circular device, which was attached to the skin; the outline of each circular device was drawn on the skin using an indelible marker. IMP was applied by site staff once daily 6 days a week for 4 weeks. A blinded investigator assessed test sites twice weekly for the severity of the clinical signs erythema, scaling, and infiltration.

    Serious adverse events
    Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 50 (28.00%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Migraine
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2
    Neck pain
         subjects affected / exposed
    2 / 50 (4.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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