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    Clinical Trial Results:
    A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with hydrocortisone 10 mg/g ointment, both applied once daily in the treatment of psoriasis vulgaris on the face and intertriginous areas (Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) with Psoriasis Vulgaris on the Face and on the Intertriginous Areas)

    Summary
    EudraCT number
    		 2009-010963-18
    Trial protocol
    		 DE   FR  
    Global end of trial date
    08 Jun 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2016
    First version publication date
    22 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LEO80190-O25
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01007591
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LEO Pharma A/S
    Sponsor organisation address
    Industriparken 55, Ballerup, Denmark,
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000277-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Jun 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with an ointment containing hydrocortisone 10 mg/g in paediatric patients with psoriasis vulgaris on the face.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2009
    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
    France: 16
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Canada: 8
    Worldwide total number of subjects
    40
    EEA total number of subjects
    32
    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)
    21
    Adolescents (12-17 years)
    19
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Before randomization the study participants entered a washout period.

    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
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment
    Arm description
    		 the 10 mg/g ointment is the LEO 80910 ointment
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEO 80190 ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) applied once daily in the treatment of psoriasis vulgaris on the face and intertriginous areas for 8 weeks (56 days)

    Arm title
    		 Hydrocortisone 10 mg/g Ointment
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hydrocortisone 1% Ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Hydrocortisone 10 mg/g (LEO 80190 ointment) applied once daily in the treatment of psoriasis vulgaris on the face and intertriginous areas for 8 weeks

    Number of subjects in period 1
    		Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Started
    27
    13
    Completed
    26
    12
    Not completed
    1
    1
         Voluntary
    -
    1
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment
    Reporting group description
    		 the 10 mg/g ointment is the LEO 80910 ointment

    Reporting group title
    Hydrocortisone 10 mg/g Ointment
    Reporting group description
    		 -

    Reporting group values
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment Total
    Number of subjects
    		 27 13 40
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 14 7 21
        Adolescents (12-17 years)
    		 13 6 19
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 11.8 (6 to 17) 11.6 (6 to 17) -
    Gender categorical
    Units: Subjects
        Female
    		 19 7 26
        Male
    		 8 6 14

    End points

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    End points reporting groups
    Reporting group title
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment
    Reporting group description
    		 the 10 mg/g ointment is the LEO 80910 ointment

    Reporting group title
    Hydrocortisone 10 mg/g Ointment
    Reporting group description
    		 -

    Primary: The percent change in Psoriasis Area and Severety Index (PASI) of the face from baseline to week 8

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    End point title
    		 The percent change in Psoriasis Area and Severety Index (PASI) of the face from baseline to week 8
    End point description
    This study only used the PASI subscale evaluating the face
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Number of subjects analysed
    27
    13
    Units: Percentage change in PASI week 8
        arithmetic mean (standard deviation)
    -60.8 ± 51.1
    -54.2 ± 59.2
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.75 [1]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - There was no statistical difference between the treatement groups (mean difference -6.02; 95% CI: -43.7, 31.7)

    Secondary: The percentage change in PASI of the face from baseline to week 4

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    End point title
    		 The percentage change in PASI of the face from baseline to week 4
    End point description
    This study only used the PASI subscale evaluating the face
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Number of subjects analysed
    27
    13
    Units: Percentage change in PASI week 4
        arithmetic mean (standard deviation)
    -54.8 ± 33.8
    54.9 ± 37.3
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.97 [2]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [2] - There was no statistically significant difference between the treatment groups (mean difference -0.43; 95% CI: -24.3 to 23.4)

    Secondary: Subjects with "controlled disease" according to the Investigator's Global Assessment (IGA) of disease severety of the face at week 8

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    End point title
    		 Subjects with "controlled disease" according to the Investigator's Global Assessment (IGA) of disease severety of the face at week 8
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Number of subjects analysed
    27
    13
    Units: Number of Subjects
    13
    7
    Statistical analysis title
    		 Analysis 1
    Statistical analysis description
    Test for homogeneity of odds ratios across age group using Breslow-Day test. The Breslow-Day test for homogeneity of the odds ratios across age group were performed using a significance level of 10%.
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0425 [3]
    Method
    		 Breslow-Day test
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.7
    Notes
    [3] - There was a significant effect of age; this is considered due to the small numbers in the age subgroups.
    Statistical analysis title
    		 Analysis 2
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.67 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 4.7
    Notes
    [4] - Treatment comparison by Cochran-Mantel-Haenszel test adjusted for age group. There was no significant difference between the treatments.

    Secondary: The percentage change in Total Sign Score (TSS) of the intertriginous areas from baseline to week 8

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    End point title
    		 The percentage change in Total Sign Score (TSS) of the intertriginous areas from baseline to week 8
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Number of subjects analysed
    7
    4
    Units: Percentage change in TSS week 8
        arithmetic mean (standard deviation)
    -56.6 ± 38.2
    -93.2 ± 8.2
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.072 [6]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [5] - They analysis of these secondary response criteria was to use the Hochberg correction to account for multiplicity.
    [6] - There was no statistically significant difference between the treatment groups (mean difference 40.58; 95% CI: -4.8 to 86.0).

    Secondary: Subjects with "controlled disease" according to the IGA of disease severity of the intertriginous areas at week 8

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    End point title
    		 Subjects with "controlled disease" according to the IGA of disease severity of the intertriginous areas at week 8
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Number of subjects analysed
    7
    4
    Units: Number of Subjects
    2
    4
    Statistical analysis title
    		 Analysis 1
    Statistical analysis description
    Test for homogeneity of odds ratios across age group using Breslow-Day test. The Breslow-Day test for homogeneity of the odds ratios across age group were performed using a significance level of 10%.
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Breslow-Day test
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 50
    Statistical analysis title
    		 Analysis 2
    Statistical analysis description
    Treatment comparison by Cochran-Mantel-Haenszel test adjusted for age group.
    Comparison groups
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment v Hydrocortisone 10 mg/g Ointment
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.059 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 50
    Notes
    [7] - There was no significant difference between the treatments.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    8 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    6.1
    Reporting groups
    Reporting group title
    Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment
    Reporting group description
    		 the 10 mg/g ointment is the LEO 80910 ointment

    Reporting group title
    Hydrocortisone 10 mg/g Ointment
    Reporting group description
    		 -

    Serious adverse events
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 13 (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
    		 Calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment Hydrocortisone 10 mg/g Ointment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 27 (62.96%)
    9 / 13 (69.23%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 13 (7.69%)
         occurrences all number
    9
    1
    General disorders and administration site conditions
    Application site burning
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    Influenza like illness
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 13 (15.38%)
         occurrences all number
    3
    2
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Nail dystrophy
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Psoriasis
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    6
    0
    Rash scaly
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Skin irritation
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Bladder infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Herpes simplex
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 27 (18.52%)
    2 / 13 (15.38%)
         occurrences all number
    6
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Sep 2009
    Definition of the contraceptive methods considered adequate for the study and an indication of the possible need for ongoing assessment of birth control methods and sexual contact during the study. Guidance on the use of concomitant therapies for psoriasis Details of unacceptable treatment efficacy for the withdrawl criteria

    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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    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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