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    Clinical Trial Results:
    Double-blind, randomised clinical study comparing efficacy and safety of Calcipotriol 50 µg/g_Betamethasone 0.5 mg/g Gel (Test) vs. Daivobet(R) Gel (Reference) vs. Vehicle in patients with scalp psoriasis.

    Summary
    EudraCT number
    2016-001106-42
    Trial protocol
    DE  
    Global end of trial date
    27 Nov 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 May 2020
    First version publication date
    15 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16-01/CalciBet-Gel
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover Ring 7, Gruenwald, Germany, 82031
    Public contact
    Clinical Research Department, Dermapharm AG, Clinicaltrials.Dermapharm@dermapharm.com
    Scientific contact
    Clinical Research Department, Dermapharm AG, Clinicaltrials.Dermapharm@dermapharm.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
    23 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy and safety of a new gel containing 50 µg/g calcipotriol and 0.5 mg/g betamethasone vs. the reference product Daivobet®Gel vs. vehicle in patients with psoriasis of the scalp. The study aimed to show non-inferiority of the test preparation as compared to Daivobet® Gel and superiority of both active medications over the vehicle.
    Protection of trial subjects
    The study was conducted in accordance with the principles of ICH GCP, the declaration of Helsinki, as well as all other applicable ethical and legal requirements. The reference product is already registered and commercially available for years in Europe. For the purpose of approval the efficacy and safety of this medicinal product has already been proven in clinical trials. An patient with lack of efficacy and/or deterioration of symptoms could stop treatment with study drug at any moment based on the clinical judgment of the investigator and/or on his/ her own request and without giving reasons. The planned procedures within the trial represented no special risk to the patients as, apart from blood sampling for laboratory safety evaluations, there were no further invasive procedures planned.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Sep 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: 234
    Worldwide total number of subjects
    234
    EEA total number of subjects
    234
    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)
    165
    From 65 to 84 years
    69
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Multi-centric study in Germany; first volunteer enrolled: 06-Dec-2016; date of last completion: 27-Nov-2017

    Pre-assignment
    Screening details
    Diagnosis and main criteria for inclusion: Women and men ≥ 18 years of age; diagnosis of “scalp psoriasis vulgaris” involving at least 20% of the total scalp area; activity parameters erythema, scaling, induration and pruritus (assessed on a scale from 0 to 3): sum score of all four parameters ≥ 6 and scaling + erythema ≥ 4 and scaling ≥ 2

    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, Monitor, Data analyst
    Blinding implementation details
    The bottles containing the study medications were neutral white. The labels on the bottles were identical for all three preparations. All three study medications were indistinguishable with respect to visual characteristics.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Test product
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Calcipotriol Combi Gel
    Investigational medicinal product code
    D05AX52
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 to 4 g per day, once daily

    Arm title
    Reference product
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Daivobet Gel
    Investigational medicinal product code
    D05AX52
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 to 4 g per day, once daily

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1 to 4 g per day, once daily

    Number of subjects in period 1
    Test product Reference product Vehicle
    Started
    79
    74
    81
    Completed
    73
    72
    75
    Not completed
    6
    2
    6
         Healing
    3
    2
    -
         Lack of efficacy
    -
    -
    2
         Adverse event, non-fatal
    3
    -
    3
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    -

    Reporting group values
    Treatment period Total
    Number of subjects
    234 234
    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)
    165 165
        From 65-84 years
    69 69
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    138 138
        Male
    96 96

    End points

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    End points reporting groups
    Reporting group title
    Test product
    Reporting group description
    -

    Reporting group title
    Reference product
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -

    Primary: Primary endpoint

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    End point title
    Primary endpoint
    End point description
    Change of the modified Total Severity Sign Score (mTSS), defined as the sum of the score values of the four activity parameters erythema, scaling, induration and pruritus.
    End point type
    Primary
    End point timeframe
    Baseline to end of week 4 (EOT)
    End point values
    Test product Reference product Vehicle
    Number of subjects analysed
    71
    67
    81
    Units: sum of score values
        arithmetic mean (confidence interval 95%)
    7.45 (7.07 to 7.84)
    7.67 (7.28 to 8.07)
    3.76 (3.21 to 4.32)
    Statistical analysis title
    Therapeutic equivalence
    Statistical analysis description
    The non-inferiority limit was set to Δ = 1.5 in the study protocol. The correspond-ing test was carried out one-sided with α = 0.025. Statistical proof of non-inferiority is attained if the lower limit of the two-sided 95% confidence interval (CI) for μTest - μReference is larger than -Δ = -1.5. Analysis of covariance (ANCOVA) with baseline adjustment was applied as testing procedure.
    Comparison groups
    Test product v Reference product
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    0.33
    Statistical analysis title
    Superiority of test product to vehicle
    Statistical analysis description
    The analysis was intended to provide supportive evidence with regard to assay sensitivity.
    Comparison groups
    Test product v Vehicle
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Superiority of reference product to vehicle
    Statistical analysis description
    This analysis was intended to provide supportive evidence to assay sensitivity.
    Comparison groups
    Reference product v Vehicle
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to the last visit (EOT, 4 weeks)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Test product
    Reporting group description
    -

    Reporting group title
    Reference product
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -

    Serious adverse events
    Test product Reference product Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    Test product Reference product Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 79 (21.52%)
    15 / 74 (20.27%)
    8 / 81 (9.88%)
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Cortisol decreased
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Cortisol increased
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    1
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 74 (2.70%)
    0 / 81 (0.00%)
         occurrences all number
    2
    2
    0
    Migraine
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    2
    0
    0
    Radiculopathy
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eczema eyelids
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Application site dryness
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Application site joint discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Application site laceration
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Application site pain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Rash papular
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Seborrhoea
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 74 (2.70%)
    2 / 81 (2.47%)
         occurrences all number
    2
    2
    2
    Endocrine disorders
    Glucocorticoid deficiency
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Eczema impetiginous
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 79 (2.53%)
    5 / 74 (6.76%)
    1 / 81 (1.23%)
         occurrences all number
    2
    5
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    0
    1
    Root canal infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    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
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