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    Clinical Trial Results:
    A multicenter, randomized, double blind, parallel group, vehicle controlled, study of the safety and efficacy of calcitriol 3 mcg/g ointment applied twice daily for 8 weeks in pediatric subjects (2 to 12 years of age) with mild to moderate plaque psoriasis

    Summary
    EudraCT number
    		 2014-001744-38
    Trial protocol
    		 DE   BE   ES   HU   IT  
    Global end of trial date
    18 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Mar 2017
    First version publication date
    26 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2RD.06.SPR.18132
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02186665
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GALDERMA R&D, LLC
    Sponsor organisation address
    5 Cedar Brook Drive Suite 1, Cranburry, United States,
    Public contact
    CTA Coordinator, GALDERMA R&D, SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, GALDERMA R&D, SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the safety of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding the face and scalp). To evaluate the effect of twice daily use of calcitriol 3 mcg/g ointment versus vehicle on calcium metabolism in children aged 2 to 12 years with plaque psoriasis (excluding face and scalp). To compare the efficacy of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis (excluding face and scalp).
    Protection of trial subjects
    All study participants were required to read and sign an informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    19
    EEA total number of subjects
    9
    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)
    16
    Adolescents (12-17 years)
    3
    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
    		 A total of 29 subjects were screened and 19 were randomized in 13 sites in US, Canada and Europe.

    Pre-assignment
    Screening details
    		 A total of 29 subjects were screened and 19 were randomized. All subjects were treated with either calcitriol ointment or its vehicle.

    Period 1
    Period 1 title
    Treatment period (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
    		 Calcitriol ointment
    Arm description
    		 calcitriol 3mcg/g ointment
    Arm type
    		 Experimental

    Investigational medicinal product name
    calcitriol 3mcg/g ointment
    Investigational medicinal product code
    CD2027
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily application (morning and evening) on psoriatic skin during 8 weeks

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    vehicle ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice daily application (morning and evening) on psoriatic skin during 8 weeks

    Number of subjects in period 1
    		Calcitriol ointment placebo
    Started
    8
    11
    Completed
    8
    10
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Calcitriol ointment
    Reporting group description
    		 calcitriol 3mcg/g ointment

    Reporting group title
    placebo
    Reporting group description
    		 -

    Reporting group values
    		 Calcitriol ointment placebo Total
    Number of subjects
    		 8 11 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 7 9 16
        Adolescents (12-17 years)
    		 1 2 3
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.6 ( 1.8 ) 9.8 ( 1.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 7 12
        Male
    		 3 4 7

    End points

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    End points reporting groups
    Reporting group title
    Calcitriol ointment
    Reporting group description
    		 calcitriol 3mcg/g ointment

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: Success of Investigator's Global Assessment ( IGA)

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    End point title
    		 Success of Investigator's Global Assessment ( IGA)
    End point description
    The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) or 1 (almost clear) at Week 8 (LOCF)
    End point type
    Primary
    End point timeframe
    Baseline to week 8
    End point values
    		 Calcitriol ointment placebo
    Number of subjects analysed
    8
    11
    Units: participants
    3
    7
    Statistical analysis title
    		 Intent to treat-Week 8-LOCF
    Statistical analysis description
    Success rate at Week 8 (ITT, LOCF) was analyzed as primary analysis. Success rate= % of subjects with an IGA of 0 (clear) or 1 (almost clear), and at least a 2 grade improvement from baseline. ITT population: All randomized subjects to whom study medication is dispensed
    Comparison groups
    Calcitriol ointment v placebo
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37 [1]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - P-value is based on Fisher's exact test.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    16 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Calcitriol ointment
    Reporting group description
    		 calcitriol 3mcg/g ointment

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Calcitriol ointment placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 11 (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
    		 Calcitriol ointment placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    8 / 11 (72.73%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    Urine calcium/creatinine ratio increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Skin irritation
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Hypercalciuria
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Infections and infestations
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Lice infestation
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Molluscum contagiosum
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    4
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 11 (9.09%)
         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.
    Study was closed early due to slow enrollment
    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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