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    Clinical Trial Results:
    Patient insights following use of LEO 90100 aerosol foam and Daivobet® gel in subjects with psoriasis vulgaris

    Summary
    EudraCT number
    		 2014-003072-24
    Trial protocol
    		 DE  
    Global end of trial date
    03 Aug 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Nov 2016
    First version publication date
    17 Aug 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor updates for better read flow.

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0053-1030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02310646
    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
    29 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 122
    Country: Number of subjects enrolled
    Germany: 97
    Worldwide total number of subjects
    219
    EEA total number of subjects
    97
    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)
    167
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 219 subjects from Canada (8 sites) and Germany (7 sites) were enrolled into the trial. First Subject First Visit:10-Feb-2015 and Last Subject Last Visit: 03-Aug-2015 (last visit, including follow-up). 6 enrolled subjects were not randomised.

    Pre-assignment
    Screening details
    		 Screening assessments were performed at the Screening Visit which could occur up to 28 days prior to Baseline (Day 1; Visit 1). A washout period of up to 4 weeks was to be completed if the subject was treated or had recently been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label, cross-over study. All subjects received both treatments, each for 1 week, and hence served as their own control. A cross-over design was selected to be able to test if the sequence of applying the treatments had an influence on preference.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Foam - Gel
    Arm description
    		 Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daivobet® gel
    Investigational medicinal product code
    Other name
    Dovobet®
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) gel 60 g per bottle, applied once daily for one week. Applied to psoriasis lesions on the trunk and/or limbs. Subjects were instructed not to apply the IMP on the face, scalp, genitals, and skin folds.

    Investigational medicinal product name
    LEO 90100 aerosol foam
    Investigational medicinal product code
    LEO 90100
    Other name
    Enstilar® foam
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) aerosol foam 60 g per can, applied once daily for one week. Applied to psoriasis lesions on the trunk and/or limbs. Subjects were instructed not to apply the IMP on the face, scalp, genitals, and skin folds.

    Arm title
    		 Gel - Foam
    Arm description
    		 Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 90100 aerosol foam
    Investigational medicinal product code
    LEO 90100
    Other name
    Enstilar® foam
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) aerosol foam 60 g per can, applied once daily for one week. Applied to psoriasis lesions on the trunk and/or limbs. Subjects were instructed not to apply the IMP on the face, scalp, genitals, and skin folds.

    Investigational medicinal product name
    Daivobet® gel
    Investigational medicinal product code
    Other name
    Dovobet®
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) gel 60 g per bottle, applied once daily for one week. Applied to psoriasis lesions on the trunk and/or limbs. Subjects were instructed not to apply the IMP on the face, scalp, genitals, and skin folds.

    Number of subjects in period 1 [1]
    		Foam - Gel Gel - Foam
    Started
    109
    104
    First Intervention (Day 1 - Day 7)
    109
    104
    Second Intervention (Day 8 - Day 14)
    107
    104
    Completed
    107
    104
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 6 enrolled subjects were not randomised due to inclusion/exclusion criteria.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Foam - Gel
    Reporting group description
    		 Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel

    Reporting group title
    Gel - Foam
    Reporting group description
    		 Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

    Reporting group values
    		 Foam - Gel Gel - Foam Total
    Number of subjects
    		 109 104 213
    Age categorical
    Units: Subjects
        Adults (18-39 years)
    		 26 23 49
        Adults (40-59 years)
    		 43 49 92
        From 60-84 years
    		 40 32 72
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52 ± 14 51.6 ± 14.2 -
    Gender categorical
    Units: Subjects
        Female
    		 46 34 80
        Male
    		 63 70 133

    End points

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    End points reporting groups
    Reporting group title
    Foam - Gel
    Reporting group description
    		 Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel

    Reporting group title
    Gel - Foam
    Reporting group description
    		 Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

    Subject analysis set title
    Latest topical treatment
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison to Latest Topical Treatment (CLTT) analysis set was defined by including all randomised subjects who had used topical anti-psoriatic medication on the treatment area (trunk and/or limbs) within 3 months prior to Baseline.

    Subject analysis set title
    All subjects foam
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects that received both treatments (foam and gel) are included in the full analysis set (FAS). One subject in the foam-gel group discontinued from the trial prior to the Week 1 visit (after 7 days of treatment with LEO 90100) and did not complete any on-treatment questionnaires, and was excluded from the FAS which hence comprised 212 subjects: 108 subjects in the foam-gel group and 104 subjects in the gel-foam group. All subjects foam=All subjects gel=All randomized subjects. These 3 different names are used for endpoint reporting to clarify the treatment referred to.

    Subject analysis set title
    All subjects gel
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects that received both treatments (foam and gel) are included in the full analysis set (FAS). One subject in the foam-gel group discontinued from the trial prior to the Week 1 visit (after 7 days of treatment with LEO 90100) and did not complete any on-treatment questionnaires, and was excluded from the FAS which hence comprised 212 subjects: 108 subjects in the foam-gel group and 104 subjects in the gel-foam group. All subjects foam=All subjects gel=All randomized subjects. These 3 different names are used for endpoint reporting to clarify the treatment referred to.

    Subject analysis set title
    All randomised subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects that received both treatments (foam and gel) are included in the full analysis set (FAS). One subject in the foam-gel group discontinued from the trial prior to the Week 1 visit (after 7 days of treatment with LEO 90100) and did not complete any on-treatment questionnaires, and was excluded from the FAS which hence comprised 212 subjects: 108 subjects in the foam-gel group and 104 subjects in the gel-foam group. All subjects foam=All subjects gel=All randomized subjects. These 3 different names are used for endpoint reporting to clarify the treatment referred to.

    Subject analysis set title
    Prefer Foam (very important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Foam (fairly important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Foam (not very important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Foam (not at all important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Gel (very important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Gel (fairly important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Gel (not very important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Subject analysis set title
    Prefer Gel (not at all important factor)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Created for response criteria results representation purposes - applicable to endpoint 6.

    Primary: Overall treatment preference by Subject's Preference Assessment (SPA) at Week 2 and association with baseline characteristics

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    End point title
    		 Overall treatment preference by Subject's Preference Assessment (SPA) at Week 2 and association with baseline characteristics
    End point description
    The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from ‘very important factor’ to ‘not at all important factor’. The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Results for multiple regression analyses are provided in the Clinical Study Report found on the LEO Pharma website.
    End point type
    Primary
    End point timeframe
    Baseline to Week 2
    End point values
    		 Foam - Gel Gel - Foam All randomised subjects
    Number of subjects analysed
    108
    104
    212
    Units: percent
    number (not applicable)
        Overall, I preferred the aerosol foam
    52.9
    46.2
    49.5
        Overall, I preferred the gel in a bottle
    47.1
    53.8
    50.5
    Statistical analysis title
    		 Treatment sequence and gender
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: gender (male, female).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2 [1]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [1] - Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p<0.05
    Statistical analysis title
    		 Treatment sequence and age
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: age (18-39 years, 40-59 years, ≥60 years).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [2]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [2] - Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p<0.05.
    Statistical analysis title
    		 Treatment sequence and baseline disease severity
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: Baseline disease severity (mild, moderate, severe).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.29 [3]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [3] - Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p<0.05
    Statistical analysis title
    		 Treatment sequence and distribution phenotype
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: distribution phenotype (localised, widespread).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.55 [4]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [4] - Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p<0.05
    Statistical analysis title
    		 Treatment sequence and plaque size
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: plaque size (≤3 mm diameter, >3 mm diameter).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25 [5]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [5] - Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, >3 mm diameter): p=0.25; threshold for statistical significance: p<0.05
    Statistical analysis title
    		 Treatment sequence and thickness
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: skin thickness phenotype (≤0.75 mm, >0.75 mm).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41 [6]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [6] - Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, >0.75 mm) effect: p=0.41; threshold for statistical significance: p<0.05
    Statistical analysis title
    		 Treatment sequence and age onset phenotype
    Statistical analysis description
    The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Baseline factor: onset phenotype (≤40 years of age, >40 years of age).
    Comparison groups
    Foam - Gel v Gel - Foam
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2 [7]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [7] - Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, >40 years of age) effect: p=0.20; threshold for statistical significance: p<0.05

    Other pre-specified: Within subject difference in response to Topical Product Usability Questionnaire (TPUQ) items between trial treatments

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    End point title
    		 Within subject difference in response to Topical Product Usability Questionnaire (TPUQ) items between trial treatments
    End point description
    Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, each response category was assigned a score (from -2=very dissatisfied to 2=very satisfied). Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains’ items. A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain. Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 2
    End point values
    		 All subjects foam All subjects gel
    Number of subjects analysed
    212
    212
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        1. Ease of application
    1.1 ± 1.2
    1.5 ± 0.9
        2. Ease of application on psoriasis lesions only
    0.9 ± 1.3
    1.4 ± 0.9
        3. Ease of spreading
    1.5 ± 0.8
    1.7 ± 0.7
        4. Lack of mess when applying
    0.8 ± 1.2
    1 ± 1.2
        5. Good for use on smaller areas
    1 ± 1.2
    1.4 ± 0.9
        6. Good for use on larger areas
    1.4 ± 0.9
    1.5 ± 0.8
        7. Quick to apply
    1.4 ± 0.8
    1.4 ± 0.9
        8. Total time spent acceptable
    1.5 ± 0.7
    1.5 ± 0.8
        9. Easily incorporated into daily routine
    1.4 ± 0.9
    1.5 ± 0.9
        Total application score (summary score)
    11.1 ± 6.9
    12.8 ± 6.1
        10. Quickly absorbed
    0.7 ± 1.3
    0.7 ± 1.3
        11. Dried quickly
    0.5 ± 1.3
    0.5 ± 1.3
        12. Gave an immediate feeling of relief
    1 ± 1
    0.7 ± 1
        13. Felt soothing to my skin
    1.2 ± 1
    1 ± 0.9
        14. Appealing to touch
    0.9 ± 1.1
    0.9 ± 1.1
        15. Felt moisturising to my skin
    1.1 ± 1
    1.2 ± 0.9
        16. Not greasy
    0 ± 1.5
    0.3 ± 1.4
        17. Odourless
    1.3 ± 1
    1.6 ± 0.7
        18. Lack of staining of clothes/bed linen
    1 ± 1.3
    1 ± 1.3
        Total formulation score (summary score)
    7.7 ± 7.2
    8 ± 7.4
        19. Easy to get medication out of container
    1.1 ± 1.2
    1.3 ± 1
        20. Easy to use container
    1.1 ± 1.2
    1.4 ± 0.9
        21. Easy to keep container clean
    1.2 ± 1.1
    1.4 ± 1
        22. Accurately dispense wanted amount
    0.9 ± 1.2
    1.5 ± 0.9
        Total container score (summary score)
    4.3 ± 3.8
    5.6 ± 3.3
        23.Confidence in using the product
    1.2 ± 1.1
    1.2 ± 1
        24. Would regularly use the product
    1.3 ± 1.2
    1.3 ± 1
        25. Would recommend the product
    1.2 ± 1.1
    1.1 ± 1.1
        Total satisfaction score (summary score)
    3.6 ± 3.2
    3.7 ± 2.9
        Total TPUQ (summary score item 1-25)
    26.8 ± 17.8
    29.9 ± 16.9
        26. Overall satisfaction score
    1.1 ± 1
    1.2 ± 1
    Statistical analysis title
    		 Comparison Gel versus Foam
    Comparison groups
    All subjects foam v All subjects gel
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.007 [9]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.
    [9] - The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007). Threshold for statistical significance: p<0.05.

    Other pre-specified: Within subject difference in response to TPUQ between the latest topical anti-psoriatic treatment and each of the 2 trial treatments

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    End point title
    		 Within subject difference in response to TPUQ between the latest topical anti-psoriatic treatment and each of the 2 trial treatments
    End point description
    The TPUQ tool was used to evaluate the subject’s latest topical treatment at Baseline (used within 3 months prior Baseline). TPUQ assessments of trial treatments at Week 1 and Week 2. Each response category was assigned a numeric score as described in Primary endpoint. For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 2
    End point values
    		 Latest topical treatment All subjects foam All subjects gel
    Number of subjects analysed
    118
    118
    118
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Total application score (summary score)
    9.9 ± 6.7
    11.5 ± 6.7
    12.5 ± 6.7
        Total formulation score (summary score)
    2.8 ± 7.5
    8.3 ± 7.2
    7.5 ± 8
        Total container score (summary score)
    4.6 ± 3.7
    4.6 ± 3.4
    5.5 ± 3.4
        Total satisfaction score (summary score)
    2 ± 3
    4 ± 3
    3.4 ± 3.2
        Total TPUQ score (items 1-25)
    19.4 ± 16.9
    28.4 ± 17.1
    29 ± 18.6
        26. Overall satisfaction score
    0.3 ± 1.1
    1.2 ± 1
    1.1 ± 1.1
    Statistical analysis title
    		 Comparison Gel vs. latest treatment
    Statistical analysis description
    Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.
    Comparison groups
    All subjects gel v Latest topical treatment
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [10]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [10] - Wilcoxon signed rank test comparing within subject difference to latest topical treatment.
    Statistical analysis title
    		 Comparison Foam vs. latest treatment
    Statistical analysis description
    Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.
    Comparison groups
    All subjects foam v Latest topical treatment
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [11]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [11] - Wilcoxon signed rank test comparing within subject difference to latest topical treatment.

    Other pre-specified: Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for each of the 2 trial treatments

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    End point title
    		 Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for each of the 2 trial treatments
    End point description
    Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference. The subject compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either ‘prefer latest treatment’, ‘no preference’, or ‘prefer trial medication (foam or gel)’. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel.
    End point type
    Other pre-specified
    End point timeframe
    At Week 1 and Week 2
    End point values
    		 All subjects foam All subjects gel
    Number of subjects analysed
    118
    118
    Units: Percent
    number (not applicable)
        Total - Prefer trial medication (Foam or Gel)
    76.5
    70.2
    No statistical analyses for this end point

    Other pre-specified: Within subject difference in response to vehicle preference measure (VPM) items between trial treatments

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    End point title
    		 Within subject difference in response to vehicle preference measure (VPM) items between trial treatments
    End point description
    The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21.
    End point type
    Other pre-specified
    End point timeframe
    Week 1 and Week 2
    End point values
    		 All subjects foam All subjects gel
    Number of subjects analysed
    212
    212
    Units: Scores on a scale
    number (not applicable)
        Ease of application
    1.5
    1.9
        Time it takes to apply
    1.9
    2
        How well it is absorbed
    1.4
    1.4
        How it feels to touch
    1.4
    1.6
        How it smells
    1.6
    1.9
        How it feels on the skin
    1.8
    1.8
        How much it stains
    1.4
    1.3
        Total VPM score (summary score)
    11.1
    12
    No statistical analyses for this end point

    Other pre-specified: Reasons for overall preference as assessed by SPA at Week 2

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    End point title
    		 Reasons for overall preference as assessed by SPA at Week 2
    End point description
    Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel).
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 2
    End point values
    		 Prefer Foam (very important factor) Prefer Foam (fairly important factor) Prefer Foam (not very important factor) Prefer Foam (not at all important factor) Prefer Gel (very important factor) Prefer Gel (fairly important factor) Prefer Gel (not very important factor) Prefer Gel (not at all important factor)
    Number of subjects analysed
    103
    103
    103
    103
    105
    105
    105
    105
    Units: Percent
    number (not applicable)
        1. The medication was easy to apply
    51.5
    30.1
    12.6
    5.8
    54.3
    37.1
    4.8
    3.8
        2. Easy application on psoriasis lesions only
    48.5
    31.1
    14.6
    5.8
    61
    30.5
    4.8
    3.8
        3. Easy to spread
    65
    24.3
    4.9
    5.8
    52.4
    41
    2.9
    3.8
        4. Applying the medication was not messy
    47.6
    34
    15.5
    2.9
    45.7
    44.8
    4.8
    4.8
        5. Overall good for smaller areas
    53.6
    29.9
    8.2
    8.2
    50.5
    38.4
    7.1
    4
        6. Overall good for larger areas
    61.8
    25.8
    5.6
    6.7
    44.2
    42.1
    10.5
    3.2
        7. Treatment was quick to apply
    55.3
    34
    7.8
    2.9
    45.7
    45.7
    4.8
    3.8
        8. Total time spent on treatment acceptable
    57.3
    26.2
    11.7
    4.9
    48.6
    41.9
    6.7
    2.9
        9. Applying treatment easy in daily routine
    61.2
    24.3
    10.7
    3.9
    56.2
    36.2
    3.8
    3.8
        10. Treatment quickly absorbed
    51.5
    32
    11.7
    4.9
    50.5
    39
    9.5
    1
        11. Treatment dried quickly
    45.6
    35
    17.5
    1.9
    50.5
    39
    9.5
    1
        12. Treatment gave immediate feeling of relief
    48.5
    31.1
    18.4
    1.9
    39
    41
    17.1
    2.9
        13. The medication felt soothing to my skin
    50.5
    36.9
    8.7
    3.9
    46.7
    39
    12.4
    1.9
        14. The medication was appealing to touch
    44.7
    34
    14.6
    6.8
    34.3
    39
    21
    5.7
        15. Treatment felt moisturising to my skin
    45.6
    38.8
    11.7
    3.9
    41
    43.8
    12.4
    2.9
        16. Treatment not too greasy
    48.5
    30.1
    17.5
    3.9
    43.8
    38.1
    15.2
    2.9
        17. Treatment was odourless
    46.6
    26.2
    18.4
    8.7
    38.1
    41
    16.2
    4.8
        18. Absence of staining of clothes/bed linen
    53.4
    31.1
    11.7
    3.9
    54.3
    36.2
    7.6
    1.9
        19. Easy to get medication out of container
    52.4
    32
    10.7
    4.9
    52.4
    41
    2.9
    3.8
        20. Container was easy to use
    55.3
    31.1
    10.7
    2.9
    57.1
    36.2
    4.8
    1.9
        21. Easy to keep container container clean
    42.7
    33
    16.5
    7.8
    45.7
    38.1
    16.2
    0
        22. Dispensing the desired amount
    54.4
    34
    8.7
    2.9
    59
    33.3
    5.7
    1.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 weeks
    Adverse event reporting additional description
    21 subjects (9.9%) experienced a total of 21 treatment-emergent AEs. No SAEs, severe AEs or AEs leading to withdrawal were observed. 2 subjects had AEs which were assessed as related to study treatment by the investigator: one subject in the foam-gel group experienced folliculitis, and one subject in the gel-foam group experienced dermatitis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Gel - Foam
    Reporting group description
    		 Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.

    Reporting group title
    Foam - Gel
    Reporting group description
    		 Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.

    Serious adverse events
    		 Gel - Foam Foam - Gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 109 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Gel - Foam Foam - Gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 104 (7.69%)
    13 / 109 (11.93%)
    Investigations
    Arthroscopy
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    Ligament rupture
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 104 (1.92%)
    2 / 109 (1.83%)
         occurrences all number
    2
    2
    Bronchitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 109 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 109 (0.92%)
         occurrences all number
    0
    0

    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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