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    Clinical Trial Results:
    A psoriasis plaque test trial with LEO 90100 compared to Betesil® in patients with psoriasis vulgaris

    Summary
    EudraCT number
    		 2015-001798-41
    Trial protocol
    		 FR  
    Global end of trial date
    07 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2016
    First version publication date
    14 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0053-1227
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02518048
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark, 2750
    Public contact
    Clinical Trials Disclosure Manager, LEO Pharma A/S, 45 4494 5888, ctr.disclosure@leo-pharma.com
    Scientific contact
    Clinical Trials Disclosure Manager, LEO Pharma A/S, 45 4494 5888, 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
    31 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster.
    Protection of trial subjects
    The clinical trial was conducted to conform to the principles of the Declaration of Helsinki as adopted by the 18th World Medical Association General Assembly, 1964, and subsequent amendments. All subjects received written and verbal information concerning the clinical trial. This information emphasised that participation in the clinical trial was voluntary and that the subject could withdraw from the clinical trial at any time and for any reason. All subjects were given an opportunity to ask questions and were given sufficient time to consider before consenting.
    Background therapy
    		 -
    Evidence for comparator
    		 The active comparator used in this trial is Betesil® medicated plaster, a potent corticosteroid indicated for the treatment of psoriasis vulgaris and other inflammatory skin disorders. Each plaster contains 2.25 mg of betamethasone 17-valerate and may be cut to fit the shape and size of the plaque to be treated. Betesil® medicated plaster has been on the market in the US and in Europe for several years and is considered safe and effective. The aim of this trial was to evaluate the anti-psoriatic effect of LEO 90100 compared with Betesil® medicated plaster by using a psoriasis plaque test.
    Actual start date of recruitment
    07 Sep 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: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    28
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 35 subjects from 1 centre in France were enrolled into the trial. The first subject was enrolled on 22-Sep-2015 and the last subject completed the trial (last visit, including follow-up) on 07-Dec-2015.

    Pre-assignment
    Screening details
    		 There were 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
    All applications of trial medication were performed by designated trial personnel at the trial site. Only they had access to the randomisation code list with the application schemes. The investigators performing the clinical assessments were not allowed to apply trial medication or to replace the non-occlusive gauze and the medicated plaster, and subjects were instructed not to reveal any information about the trial medications to them.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 LEO 90100 aerosol foam
    Arm description
    		 Each subject had 6 test sites located within 2 or 3 psoriasis plaques on the body. Depending on the size of these plaques, 2 or 4 test sites were located within the same plaque. Treatments were allocated randomly but always pair-wise within each plaque.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 90100
    Investigational medicinal product code
    Other name
    Enstilar®
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    At the Screening Visit, 2 or preferably 3 lesions (“target plaques”) were identified on the arms, legs, and/or trunk of the subject. At Baseline, the investigator selected a total of 6 small sites (“test sites”; each 5 cm²) within these target plaques. Test sites were marked with a numbered, disposable circular device attached to the skin and mapped on a drawn figure. Further, the outline of each circular device was drawn on the skin using an indelible marker. Following randomisation, the site staff applied the 2 treatments to the test sites (each treatment to 3 designated test sites): --LEO 90100 (calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g) was sprayed on the test sites and gently rubbed into the skin using a gloved finger. Each test site was treated with 50 mg of LEO 90100 (amount left after evaporation of propellants).

    Investigational medicinal product name
    Betesil®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    At the Screening Visit, 2 or preferably 3 lesions (“target plaques”) were identified on the arms, legs, and/or trunk of the subject. At Baseline, the investigator selected a total of 6 small sites (“test sites”; each 5 cm²) within these target plaques. Test sites were marked with a numbered, disposable circular device attached to the skin and mapped on a drawn figure. Further, the outline of each circular device was drawn on the skin using an indelible marker. Following randomisation, the site staff applied the 2 treatments to the test sites (each treatment to 3 designated test sites): --Betesil® (betamethasone (as valerate)) medicated plasters were cut into smaller pieces, each piece with the size of a test site. These pieces of plaster were then attached to the 3 test sites.

    Arm title
    		 Betesil®
    Arm description
    		 Each subject had 6 test sites located within 2 or 3 psoriasis plaques on the body. Depending on the size of these plaques, 2 or 4 test sites were located within the same plaque. Treatments were allocated randomly but always pair-wise within each plaque.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Betesil®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    At the Screening Visit, 2 or preferably 3 lesions (“target plaques”) were identified on the arms, legs, and/or trunk of the subject. At Baseline, the investigator selected a total of 6 small sites (“test sites”; each 5 cm²) within these target plaques. Test sites were marked with a numbered, disposable circular device attached to the skin and mapped on a drawn figure. Further, the outline of each circular device was drawn on the skin using an indelible marker. Following randomisation, the site staff applied the 2 treatments to the test sites (each treatment to 3 designated test sites): --Betesil® (betamethasone (as valerate)) medicated plasters were cut into smaller pieces, each piece with the size of a test site. These pieces of plaster were then attached to the 3 test sites.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Due to the different formulations of the 2 IMPs (foam versus plaster), a double-blind design was not possible and the trial was performed as an investigator-blinded trial.
    Number of subjects in period 1
    		LEO 90100 aerosol foam Betesil®
    Started
    35
    35
    Completed
    34
    34
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    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
    		 35 35
    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)
    		 28 28
        From 65-84 years
    		 7 7
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    LEO 90100 aerosol foam
    Reporting group description
    		 Each subject had 6 test sites located within 2 or 3 psoriasis plaques on the body. Depending on the size of these plaques, 2 or 4 test sites were located within the same plaque. Treatments were allocated randomly but always pair-wise within each plaque.

    Reporting group title
    Betesil®
    Reporting group description
    		 Each subject had 6 test sites located within 2 or 3 psoriasis plaques on the body. Depending on the size of these plaques, 2 or 4 test sites were located within the same plaque. Treatments were allocated randomly but always pair-wise within each plaque.

    Primary: Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling, and infiltration) at end of treatment compared to Baseline

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    End point title
    		 Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling, and infiltration) at end of treatment compared to Baseline
    End point description
    The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT). The mean TCS at Baseline was 6.6 for both groups.
    End point type
    Primary
    End point timeframe
    Baseline to End of Treatment (EoT)
    End point values
    		 LEO 90100 aerosol foam Betesil®
    Number of subjects analysed
    35
    35
    Units: Units on a scale
    arithmetic mean (standard deviation)
        TCS at Baseline
    6.6 ( 0.6 )
    6.6 ( 0.6 )
        Change in TCS Baseline to EoT
    -5.8 ( 1.1 )
    -3.6 ( 1.5 )
    Statistical analysis title
    		 Comparison
    Statistical analysis description
    A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values. The number of subjects in the analysis is 35 - not 70. All 35 subjects received both treatments.
    Comparison groups
    LEO 90100 aerosol foam v Betesil®
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.58
         upper limit
    		 -1.76
    Notes
    [1] - Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).

    Secondary: Change in TCS at Individual Visits

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    End point title
    		 Change in TCS at Individual Visits
    End point description
    The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe). TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site. Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment
    End point values
    		 LEO 90100 aerosol foam Betesil®
    Number of subjects analysed
    35
    35
    Units: Units on a score
    arithmetic mean (standard deviation)
        Day 4/Visit 5
    -1.3 ( 0.8 )
    -1.3 ( 0.7 )
        Day 8/Visit 8
    -3.2 ( 1.2 )
    -2 ( 1.1 )
        Day 11/Visit 11
    -4.3 ( 1.1 )
    -2.4 ( 1.4 )
        Day 15/Visit 15
    -4.8 ( 1.2 )
    -2.8 ( 1.4 )
        Day 17/Visit 18
    -5.1 ( 1.2 )
    -3.1 ( 1.5 )
        Day 22/Visit 20
    -5.5 ( 1.2 )
    -3.2 ( 1.6 )
        Day 25/Visit 23
    -5.7 ( 1.1 )
    -3.6 ( 1.6 )
        Day 29/Visit 26
    -5.9 ( 1.1 )
    -3.7 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Change in Score of Erythema, Scaling, and Infiltration at Individual Visits

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    End point title
    		 Change in Score of Erythema, Scaling, and Infiltration at Individual Visits
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment
    End point values
    		 LEO 90100 aerosol foam Betesil®
    Number of subjects analysed
    35
    35
    Units: units on a scale
    arithmetic mean (standard deviation)
        Erythema Day 4/Visit 5
    -0.5 ( 0.4 )
    -0.4 ( 0.4 )
        Erythema Day 8/Visit 8
    -0.9 ( 0.4 )
    -0.6 ( 0.4 )
        Erythema Day 11/Visit 11
    -1.3 ( 0.5 )
    -0.8 ( 0.5 )
        Erythema Day 15/Visit 14
    -1.4 ( 0.5 )
    -0.9 ( 0.5 )
        Erythema Day 18/Visit 17
    -1.6 ( 0.6 )
    -1 ( 0.6 )
        Erythema Day 22/Visit 20
    -1.7 ( 0.6 )
    -1.1 ( 0.6 )
        Erythema Day 25/Visit 23
    -1.8 ( 0.6 )
    -1.3 ( 0.6 )
        Erythema Day 29/Visit 26
    -1.9 ( 0.5 )
    -1.2 ( 0.6 )
        Scaling Day 4/Visit 5
    -0.6 ( 0.3 )
    -0.6 ( 0.3 )
        Scaling Day 8/Visit 8
    -1.3 ( 0.5 )
    -0.8 ( 0.5 )
        Scaling Day 11/Visit 11
    -1.7 ( 0.5 )
    -1 ( 0.6 )
        Scaling Day 15/Visit 14
    -1.8 ( 0.5 )
    -1.1 ( 0.6 )
        Scaling Day 18/Visit 17
    -1.9 ( 0.5 )
    -1.2 ( 0.6 )
        Scaling Day 22/Visit 20
    -2 ( 0.5 )
    -1.2 ( 0.6 )
        Scaling Day 25/Visit 23
    -2 ( 0.4 )
    -1.4 ( 0.6 )
        Scaling Day 29/Visit 26
    -2 ( 0.4 )
    -1.3 ( 0.6 )
        Infiltration Day 4/Visit 5
    -0.3 ( 0.2 )
    -0.3 ( 0.2 )
        Infiltration Day 8/Visit 8
    -0.9 ( 0.5 )
    -0.5 ( 0.4 )
        Infiltration Day 11/Visit 11
    -1.3 ( 0.4 )
    -0.6 ( 0.5 )
        Infiltration Day 15/Visit 14
    -1.6 ( 0.4 )
    -0.8 ( 0.5 )
        Infiltration Day 18/Visit 17
    -1.7 ( 0.4 )
    -0.8 ( 0.6 )
        Infiltration Day 22/Visit 20
    -1.8 ( 0.3 )
    -0.9 ( 0.6 )
        Infiltration Day 25/Visit 23
    -1.9 ( 0.3 )
    -1 ( 0.6 )
        Infiltration Day 29/Visit 26
    -1.9 ( 0.3 )
    -1.1 ( 0.6 )
    No statistical analyses for this end point

    Secondary: Change in total skin thickness and echo-poor band thickness from Baseline to EoT

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    End point title
    		 Change in total skin thickness and echo-poor band thickness from Baseline to EoT
    End point description
    Skin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment. Two skin parameters were calculated using ultrasound: --The mean total skin thickness --The mean echo-poor band thickness
    End point type
    Secondary
    End point timeframe
    Baseline to EoT
    End point values
    		 LEO 90100 aerosol foam Betesil®
    Number of subjects analysed
    35
    35
    Units: millimeter(s)
    arithmetic mean (standard deviation)
        Change in Total Skin Thickness
    -1 ( 0.3 )
    -0.6 ( 0.4 )
        Change in Echo-Poor Band Thickness
    -1.3 ( 0.5 )
    -0.7 ( 0.5 )
    Statistical analysis title
    		 Total Skin Thickness: LEO 90100 vs. Betesil®
    Comparison groups
    LEO 90100 aerosol foam v Betesil®
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 -0.32
    Notes
    [2] - Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)
    Statistical analysis title
    		 Echo-Poor Band Thickness: LEO 90100 vs. Betesil®
    Comparison groups
    Betesil® v LEO 90100 aerosol foam
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 -0.41
    Notes
    [3] - Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signed Informed consent form (Day -28 to -1) to end of Follow-up (Day 43 +/-2).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 35 (42.86%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 35 (14.29%)
         occurrences all number
    8
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Asthma
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Hordeolum
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2015
    One substantial amendment was made to the clinical trial protocol to include the new address of the contract manufacturing organisation responsible for the secondary packaging, labelling, and distribution of IMP. The contract manufacturing organisation was also responsible for the destruction of returned IMP. The new version of the clinical trial protocol (version 2, dated 26-Aug-2015) was approved by the regulatory authority prior to trial start.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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