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    Clinical Trial Results:
    A designed Patient-centered Intervention to Improve medical Adherence in Topical Treatment of psoriasis - A Study protocol

    Summary
    EudraCT number
    		 2016-002143-42
    Trial protocol
    		 DK  
    Global end of trial date
    29 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2017
    First version publication date
    23 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02858713
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    Kløvervænget 15, Odense, Denmark, 5000
    Public contact
    Mathias Tiedemann Svendsen, Odense University Hospital, +45 65413239, mathias.tiedemann.svendsen@rsyd.dk
    Scientific contact
    Mathias Tiedemann Svendsen, Odense University Hospital, +45 65413239, mathias.tiedemann.svendsen@rsyd.dk
    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
    21 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Test if an app for smartphones can improve Medical adherence in psoriasis patients
    Protection of trial subjects
    Assessment of adverse events at all study visits.
    Background therapy
    		 Treatment with calcipqotriol/betamethasone dipropionate cutaneous foam.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2017
    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
    Denmark: 134
    Worldwide total number of subjects
    134
    EEA total number of subjects
    134
    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)
    106
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at the dermatology outpatient clinic at Odense University Hospital and by advertisement in local news media. Patients were included in the period 9 January 2017 to 29 February 2017.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Patients (legally competent patients aged between 18-75 years) who owned a smartphone or had skills for use of a smartphone who were diagnosed with mild-to-moderate psoriasis, and who were candidates for treatment with calcipotriol/betamethasone dipropionate cutaneous foam.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Non-intervention
    Arm description
    		 Patients received topical Cal/BD cutaneous foam. The foam was prescribed for once daily application in a 28-day treatment period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    enstilar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Once daily cutaneous application

    Arm title
    		 Intervention
    Arm description
    		 Patients received topical Cal/BD cutaneous foam. The foam was prescribed for once daily application in a 28-day treatment period. In addition, the patients received a 28-day supporting app, which provided once-daily compulsory treatment reminders and daily information on number of treatment applications and applied amount of prescribed Cal/BD cutaneous foam. The information was obtained by the chip in the electronic monitor synchronizing via Bluetooth® to the app.
    Arm type
    		 Experimental

    Investigational medicinal product name
    enstilar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Once daily cutaneous application

    Number of subjects in period 1
    		Non-intervention Intervention
    Started
    66
    68
    Completed
    61
    61
    Not completed
    5
    7
         Adverse event, non-fatal
    -
    1
         Pregnancy
    1
    1
         Lost to follow-up
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Intervention (overall period) Total
    Number of subjects
    		 134 134
    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)
    		 106 106
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 52 52
        Male
    		 82 82

    End points

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    End points reporting groups
    Reporting group title
    Non-intervention
    Reporting group description
    		 Patients received topical Cal/BD cutaneous foam. The foam was prescribed for once daily application in a 28-day treatment period.

    Reporting group title
    Intervention
    Reporting group description
    		 Patients received topical Cal/BD cutaneous foam. The foam was prescribed for once daily application in a 28-day treatment period. In addition, the patients received a 28-day supporting app, which provided once-daily compulsory treatment reminders and daily information on number of treatment applications and applied amount of prescribed Cal/BD cutaneous foam. The information was obtained by the chip in the electronic monitor synchronizing via Bluetooth® to the app.

    Primary: rate of secondary medical adherence

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    End point title
    		 rate of secondary medical adherence
    End point description
    End point type
    Primary
    End point timeframe
    Week 4
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    61
    59
    Units: %
    38
    65
    Statistical analysis title
    		 Rate of adherent patients
    Statistical analysis description
    we dichotomized adherence rates obtained by Electronic monitor with a selected cut-off of 80%, with adherence rates above 80% considered adherent
    Comparison groups
    Non-intervention v Intervention
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Regression, Linear
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.994
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.42
         upper limit
    		 6.28

    Secondary: LS-PGA: Change baseline to week 4

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    End point title
    		 LS-PGA: Change baseline to week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    65
    65
    Units: LS-PGA
        arithmetic mean (confidence interval 95%)
    1.46 (1.17 to 1.75)
    1.86 (1.59 to 2.13)
    Statistical analysis title
    		 LS-PGA: Chanmge baseline to week 4
    Comparison groups
    Non-intervention v Intervention
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.047
    Method
    		 Regression, Linear
    Parameter type
    		 Coefficient
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.005
         upper limit
    		 0.795

    Secondary: LS-PGA: Change baseline week 8

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    End point title
    		 LS-PGA: Change baseline week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    63
    64
    Units: LS-PGA
        arithmetic mean (confidence interval 95%)
    2.16 (1.86 to 2.46)
    2.25 (1.96 to 2.54)
    Statistical analysis title
    		 LS-PGA: Change baseline to week 8
    Comparison groups
    Non-intervention v Intervention
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.662
    Method
    		 Regression, Linear
    Parameter type
    		 Coefficient
    Point estimate
    0.091
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.321
         upper limit
    		 0.504

    Secondary: LS-PGA: Change baseline to week 26

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    End point title
    		 LS-PGA: Change baseline to week 26
    End point description
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    61
    61
    Units: LS-PGA
        arithmetic mean (confidence interval 95%)
    1.80 (1.49 to 2.11)
    1.98 (1.66 to 2.31)
    Statistical analysis title
    		 LS-PGA: Change baseline to week 26
    Comparison groups
    Non-intervention v Intervention
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.424
    Method
    		 Regression, Linear
    Parameter type
    		 Coefficient
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.264
         upper limit
    		 0.625

    Secondary: DLQI: Change baseline to week 4

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    End point title
    		 DLQI: Change baseline to week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    65
    65
    Units: DLQI
        arithmetic mean (confidence interval 95%)
    4.54 (3.47 to 5.61)
    4.12 (3.27 to 4.98)
    Statistical analysis title
    		 LS-PGA: Change baseline to week 4
    Comparison groups
    Intervention v Non-intervention
    Number of subjects included in analysis
    130
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.545
    Method
    		 Regression, Linear
    Parameter type
    		 Coefficient
    Point estimate
    -0.415
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 0.939

    Secondary: DLQI: Change baseline to week 8

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    End point title
    		 DLQI: Change baseline to week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    63
    64
    Units: DLQI
        arithmetic mean (confidence interval 95%)
    5.17 (3.92 to 6.43)
    4.59 (3.71 to 5.48)
    Statistical analysis title
    		 DLQI: Change baseline to week 8
    Comparison groups
    Non-intervention v Intervention
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45
    Method
    		 Regression, Linear
    Parameter type
    		 Coefficient
    Point estimate
    -0.581
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.099
         upper limit
    		 0.938

    Secondary: DLQI: Change baseline to week 26

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    End point title
    		 DLQI: Change baseline to week 26
    End point description
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Non-intervention Intervention
    Number of subjects analysed
    61
    61
    Units: DLQI
        arithmetic mean (confidence interval 95%)
    5.00 (3.69 to 6.31)
    4.23 (3.25 to 5.21)
    Statistical analysis title
    		 DLQI: Change baseline to week 26
    Comparison groups
    Intervention v Non-intervention
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.348
    Method
    		 Regression, Linear
    Parameter type
    		 Coefficient
    Point estimate
    -0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.389
         upper limit
    		 0.848

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline, week 4, 8 and 26.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    ADVERSE EVENTS
    Reporting group description
    		 -

    Serious adverse events
    		 ADVERSE EVENTS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 134 (0.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Musculoskeletal and connective tissue disorders
    Infection in knee prothesis
         subjects affected / exposed
    1 / 134 (0.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ADVERSE EVENTS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 134 (31.34%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Relapse of carcinoma in situ of the glottis
    Additional description: Relapse of carcinoma in situ of the glottis (not related to enstilar cutaneous foam treatment)
         subjects affected / exposed
    1 / 134 (0.75%)
         occurrences all number
    1
    Vascular disorders
    Fainting
    Additional description: Fainting (not related to enstilar cutaneous foam treatment)
         subjects affected / exposed
    1 / 134 (0.75%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Nausea
    Additional description: Nausea after accidentally inhaling gas from the Enstilar cutaneous faom canister
         subjects affected / exposed
    3 / 134 (2.24%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    Additional description: Sensation worsening of Chronic obstructive pulmonary disease when accidentally inhaled gas from the Enstilar Cutaneous foam canister.
         subjects affected / exposed
    1 / 134 (0.75%)
         occurrences all number
    1
    Hepatobiliary disorders
    Elevated liver enzymes
    Additional description: Elevated liver enzymes (not related to enstilar cutaneous foam treatment)
         subjects affected / exposed
    3 / 134 (2.24%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    various cutaneous manifestations
    Additional description: 11 different skin manifestations (none related to Enstilar cutaneous foam treatment)
         subjects affected / exposed
    16 / 134 (11.94%)
         occurrences all number
    16
    Renal and urinary disorders
    Elevated creatinin levels
    Additional description: Elevated creatinin levels (not related to enstilar cutaneous foam treatment)
         subjects affected / exposed
    1 / 134 (0.75%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Various musculoskeletal disorder
    Additional description: Various musculousskeletal disorder (not related to enstilar cutaneous foam treatment)
         subjects affected / exposed
    8 / 134 (5.97%)
         occurrences all number
    8
    Infections and infestations
    Lung and skin infection
    Additional description: Lung and skin infection (not related to enstilar cutaneous foam treatment)
         subjects affected / exposed
    8 / 134 (5.97%)
         occurrences all number
    8

    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
    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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