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    Clinical Trial Results:
    A Phase 2a, proof of concept trial, testing twice daily application of LEO 124249 ointment 30mg/g in the treatment of mild to moderate inverse psoriasis

    Summary
    EudraCT number
    2015-002098-40
    Trial protocol
    DE  
    Global end of trial date
    20 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LP0133-1182
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02695940
    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, disclosure@leo-pharma.com
    Scientific contact
    Clinical Trial Disclosure Manager, LEO Pharma A/S, +45 44945888, 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
    20 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of twice daily application of LEO 124249 ointment 30 mg/g and LEO 124249 ointment vehicle for 6 weeks in the treatment of subjects with mild to moderate inverse psoriasis.
    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
    -
    Actual start date of recruitment
    22 Feb 2016
    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
    Germany: 69
    Worldwide total number of subjects
    69
    EEA total number of subjects
    69
    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)
    69
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    110 subjects from 11 sites in Germany were screened into the trial. The first subject was enrolled on 11-Mar-2016, and the last subject completed the trial on 20-Sep-2016

    Pre-assignment
    Screening details
    Screening assessment occurred up to 28 days prior to baseline. 41 out of 110 subjects were not randomised due to the following reasons: screening failure (33 subjects), recruitment stop due to over recruitment (7 subjects), and voluntary withdrawal of consent by the subject prior to randomisation (1 subject). 69 subjects were randomised.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    LEO 124249 30mg/g
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    LEO 124249 30mg/g
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    A thin layer covering the affected area corresponding to 1.0mg/cm2 of LEO 124249 ointment 30mg/g was to be applied twice daily. Depending on the size of the affected areas, a maximum of 4% BSA or 720cm2 could be treated, corresponding to a maximum of 720mg ointment per application. IMP had to be applied morning and evening (approximately 12 hours apart, minimum 8 hours apart) with the exception of Day 1 (start of treatment), where 2 doses were to be administered regardless of timing; one at the site visit, and one administered by the subject at home in the evening.

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    A thin layer covering the affected area corresponding to 1.0mg/cm2 of LEO 124249 ointment vehicle was to be applied twice daily. Depending on the size of the affected areas, a maximum of 4% BSA or 720cm2 could be treated, corresponding to a maximum of 720mg ointment per application. IMP had to be applied morning and evening (approximately 12 hours apart, minimum 8 hours apart) with the exception of Day 1 (start of treatment), where 2 doses were to be administered regardless of timing; one at the site visit, and one administered by the subject at home in the evening.

    Number of subjects in period 1
    LEO 124249 30mg/g Vehicle
    Started
    45
    24
    Completed
    39
    21
    Not completed
    6
    3
         Lack of efficacy
    2
    -
         Adverse event, non-fatal
    1
    1
         Consent withdrawn by subject
    3
    2

    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
    69 69
    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)
    69 69
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    27 27
        Male
    42 42

    End points

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    End points reporting groups
    Reporting group title
    LEO 124249 30mg/g
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -

    Primary: The total sign score (TSS) at end of treatment (Week 6)

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    End point title
    The total sign score (TSS) at end of treatment (Week 6)
    End point description
    The severity of the inverse psoriasis was recorded for each clinical sign redness, thickness and scaliness. For each sign, a single score reflecting the average severity of all inverse psoriasis lesions were determined according to the scale below of 0 to 4. 1) Redness '0 -4' denoted none to very severe erythema, very dark red erythema 2) Thickness '0-4' denoted none, no plaque elevation to very severe, very thick plaque with sharp edge and 3) Scaliness '0-4' denoted none, no scaling to very severe, very thick coarse scales, possibly fissured
    End point type
    Primary
    End point timeframe
    From screening (28 days before baseline) to Week 6 (end of treatment). TSS was assessed at regular intervals including baseline, Week 1, Week 2, and Week 4.
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Scores on a scale
        arithmetic mean (confidence interval 95%)
    4.1 (3.5 to 4.7)
    4.2 (3.4 to 5)
    Statistical analysis title
    Total Sign Score at Week 6 (LOCF)
    Statistical analysis description
    The comparison between treatment groups was done by means of an analysis of covariance (ANCOVA) model with treatment and pooled site as factors and baseline TSS as covariate.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.89
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.09
         upper limit
    0.95

    Secondary: For Physician's Global Assessment (PGA), the number of subjects achieving controlled disease

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    End point title
    For Physician's Global Assessment (PGA), the number of subjects achieving controlled disease
    End point description
    For Physician's global assessment (PGA), the number of subjects reaching controlled disease was defined as follows: • Subjects classified as having at least ‘moderate’ disease at baseline who achieved ‘clear’ or ‘almost clear’ disease severity were considered to have controlled disease. • Subjects classified at baseline as having ‘mild’ disease had to achieve ‘clear’ to be considered having controlled disease.
    End point type
    Secondary
    End point timeframe
    From screening (28 days prior to baseline) to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Number of subjects
        Controlled disease
    4
    3
        Non-controlled disease
    35
    18
    Statistical analysis title
    Controlled disease according to PGA at Week 6
    Statistical analysis description
    The proportion of subjects with controlled disease according to Physician's Global Assessment at week 6 was compared between treatment groups using a Cochran-Mantel-Haenszel test adjusting for pooled site. Odds ratio, 95% CI and p-value presented.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.12
         upper limit
    2.76

    Secondary: Clinical sign score for redness for inverse psoriasis: (score 0 to 4)

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    End point title
    Clinical sign score for redness for inverse psoriasis: (score 0 to 4)
    End point description
    End point type
    Secondary
    End point timeframe
    From screening (28 days prior to baseline) to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Scores on a scale
        arithmetic mean (confidence interval 95%)
    1.9 (1.6 to 2.1)
    1.9 (1.6 to 2.2)
    Statistical analysis title
    Redness at Week 6
    Statistical analysis description
    Differences between treatment groups at end of treatment (Week 6) for redness was estimated using an ANCOVA model with treatment and pooled site as factors and baseline value as covariate.
    Comparison groups
    Vehicle v LEO 124249 30mg/g
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.91
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.44
         upper limit
    0.39

    Secondary: Clinical sign score for thickness for inverse psoriasis: (score 0 to 4)

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    End point title
    Clinical sign score for thickness for inverse psoriasis: (score 0 to 4)
    End point description
    End point type
    Secondary
    End point timeframe
    From screening (28 days prior to baseline) to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: On a scale of scores
        arithmetic mean (confidence interval 95%)
    1.2 (1 to 1.5)
    1.3 (0.9 to 1.6)
    Statistical analysis title
    Thickness at Week 6
    Statistical analysis description
    Differences between treatment groups at end of treatment (Week 6) for thickness was estimated using an ANCOVA model with treatment and pooled site as factors and baseline value as covariate.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.78
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.48
         upper limit
    0.36

    Secondary: Clinical sign score for scaliness for inverse psoriasis: (score 0 to 4)

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    End point title
    Clinical sign score for scaliness for inverse psoriasis: (score 0 to 4)
    End point description
    End point type
    Secondary
    End point timeframe
    From screening (28 days prior to baseline) to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Scores on a scale
        arithmetic mean (confidence interval 95%)
    0.8 (0.6 to 1.1)
    0.9 (0.5 to 1.2)
    Statistical analysis title
    Scaliness at Week 6
    Statistical analysis description
    Differences between treatment groups at end of treatment (Week 6) for scaliness was estimated using an ANCOVA model with treatment and pooled site as factors and baseline value as covariate.
    Comparison groups
    Vehicle v LEO 124249 30mg/g
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.77
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    0.35

    Secondary: Size of treatment area of inverse psoriasis

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    End point title
    Size of treatment area of inverse psoriasis
    End point description
    End point type
    Secondary
    End point timeframe
    From screening (28 days prior to baseline) to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: score on a scale
        arithmetic mean (confidence interval 95%)
    73.9 (60.1 to 87.7)
    81.3 (62.4 to 100.2)
    Statistical analysis title
    Size of treatment area of inverse psoriasis Week 6
    Statistical analysis description
    Differences between treatment groups at end of treatment (Week 6) for the size of the treatment area was estimated using an ANCOVA model with treatment and pooled site as factors and baseline value as covariate.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.53
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31.03
         upper limit
    16.17

    Secondary: For Patient's Global Assessment (PaGA), the number of subjects reaching controlled disease

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    End point title
    For Patient's Global Assessment (PaGA), the number of subjects reaching controlled disease
    End point description
    For Patient's global assessment (PaGA), the number of subjects reaching controlled disease defined as follows: • Subjects classified as having at least ‘moderate’ disease at baseline who achieved ‘clear’ or ‘very mild’ disease severity were considered to have controlled disease. • Subjects classified at baseline as having ‘mild’ disease had to achieve ‘clear’ to be considered having controlled disease.
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Number of subjects
        Controlled disease
    5
    1
        Non-controlled disease
    34
    20
    Statistical analysis title
    Controlled disease according to PaGA Week 6
    Statistical analysis description
    For PaGA, the proportion of subjects with controlled disease at end of treatment (Week 6) was compared between treatments using the Cochran-Mantel-Haenzel test adjusting for pooled site. The odds ratio (odds of controlled disease for LEO 124249 ointment 30mg/g relative to that of LEO 124249 ointment vehicle), CI for the odds ratio and the p-value presented.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.43
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.33
         upper limit
    11.97

    Secondary: Dermatology Life Quality Index (DLQI) questionnaire

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    End point title
    Dermatology Life Quality Index (DLQI) questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Quality of life index score
        arithmetic mean (confidence interval 95%)
    3.8 (2.9 to 4.7)
    4.6 (3.3 to 5.8)
    Statistical analysis title
    Total DLQI score at Week 6
    Statistical analysis description
    Differences between treatments in DLQI score at end of treatment (Week 6) were analysed using an ANCOVA model with treatment and pooled site as factors and baseline value as covariate.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.31
         upper limit
    0.83

    Secondary: Treatment Satisfaction Questionnaire for Medication (TSQM II)

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    End point title
    Treatment Satisfaction Questionnaire for Medication (TSQM II)
    End point description
    End point type
    Secondary
    End point timeframe
    At end of treatment (Week 6)
    End point values
    LEO 124249 30mg/g Vehicle
    Number of subjects analysed
    43
    24
    Units: Score on a scale
    arithmetic mean (confidence interval 95%)
        Effectiveness
    56.4 (47.2 to 65.5)
    56.3 (44 to 68.6)
        Side effects
    97.6 (95.2 to 99.9)
    99.3 (96.2 to 102.5)
        Convenience
    78.5 (72.5 to 84.4)
    76 (67.8 to 84.2)
        Global satisfaction
    65 (56.1 to 74)
    52.2 (40 to 64.5)
    Statistical analysis title
    TSQM derived scores at Week 6 - Effectiveness
    Statistical analysis description
    Differences in derived TSQM scores at end of treatment (Week 6) were analysed using an ANCOVA model with treatment and pooled site as factors.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.99
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.4
         upper limit
    15.56
    Statistical analysis title
    TSQM derived scores at Week 6 - Side Effects
    Statistical analysis description
    Differences in derived TSQM scores at end of treatment (Week 6) were analysed using an ANCOVA model with treatment and pooled site as factors.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.37
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.7
         upper limit
    2.16
    Statistical analysis title
    TSQM derived scores at Week 6 - Convenience
    Statistical analysis description
    Differences in derived TSQM scores at end of treatment (Week 6) were analysed using an ANCOVA model with treatment and pooled site as factors.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.63
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    2.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.74
         upper limit
    12.7
    Statistical analysis title
    TSQM derived scores at Week 6 -Global Satisfaction
    Statistical analysis description
    Differences in derived TSQM scores at end of treatment (Week 6) were analysed using an ANCOVA model with treatment and pooled site as factors.
    Comparison groups
    LEO 124249 30mg/g v Vehicle
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.099
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    12.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.49
         upper limit
    28.13

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening (28 days prior to baseline) to follow-up (14±2 days after end of treatment, Week 6)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    LEO 124249 30mg/g
    Reporting group description
    -

    Reporting group title
    LEO 124249 ointment vehicle
    Reporting group description
    -

    Serious adverse events
    LEO 124249 30mg/g LEO 124249 ointment vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    LEO 124249 30mg/g LEO 124249 ointment vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 45 (42.22%)
    8 / 24 (33.33%)
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    6 / 45 (13.33%)
    2 / 24 (8.33%)
         occurrences all number
    13
    2
    Contusion
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram T wave amplitude decreased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Nerve root compression
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    9
    Application site pain
         subjects affected / exposed
    3 / 45 (6.67%)
    1 / 24 (4.17%)
         occurrences all number
    3
    2
    Application site pruritus
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 24 (8.33%)
         occurrences all number
    1
    3
    Application site hypertrichosis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Lip erosion
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Skin fissures
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 45 (13.33%)
    0 / 24 (0.00%)
         occurrences all number
    7
    0
    Cystitis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Erysipelas
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1

    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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