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    Clinical Trial Results:
    Double blind, randomized, clinical study to compare the efficacy and safety of betamethasone 0,05%_salicyclic acid 2% solution vs. Diprosalic solution vs. vehicle for the treatment of psoriasis capitis

    Summary
    EudraCT number
    2010-024033-24
    Trial protocol
    DE  
    Global end of trial date
    15 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Feb 2016
    First version publication date
    14 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    11-01/BSal-L
    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, 82031, Germany, Gruenwald
    Public contact
    Head of clinical department, Dermapharm AG, 0049 08964186-0,
    Scientific contact
    Head of clinical department, Dermapharm AG, 0049 08964186-0,
    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 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2013
    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 0,05% betamethasone 2% salicylic acid solution vs. the originator Diprosalic solution (licensed) vs. vehicle in patients with psoriasis of the scalp
    Protection of trial subjects
    There were no specific measures necessary.
    Background therapy
    There was no background therapy.
    Evidence for comparator
    The trial aimed to show non-inferiority with regard to the comparator in order to obtain a generic marketing authorization for the test product.
    Actual start date of recruitment
    29 Jun 2011
    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: 225
    Worldwide total number of subjects
    225
    EEA total number of subjects
    225
    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)
    143
    From 65 to 84 years
    72
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    All study centres in Germany First patient first visit: 04 July 2011 Last patient last visit: 15 October 2013

    Pre-assignment
    Screening details
    Main criteria for inclusion: Women and men ≥ 18 years of age Diagnosis of “scalp psoriasis” according to generally accepted criteria Affection of at least 20% of the scalp Affection of up to 50% or, in case of progression of psoriasis vulgaris during the last four weeks, up to 30% of the body surface Score values as specified in the protocol

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    All study preparations were indistinguishable in terms of appearance and were filled in white bottles of identical appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BetaSal Solution
    Arm description
    Test product
    Arm type
    Experimental

    Investigational medicinal product name
    Betamethasone 0.05%_Salicylic Acid 2% Solution
    Investigational medicinal product code
    D07XC01
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice per day. Total dose depends on the extent of the area to be treated.

    Arm title
    Diprosalic Solution
    Arm description
    Reference product
    Arm type
    Active comparator

    Investigational medicinal product name
    Diprosalic
    Investigational medicinal product code
    D07XC01
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice per day. Total dose depends on the extent of the area to be treated.

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice per day. Total amount depends on the area to be treated.

    Number of subjects in period 1
    BetaSal Solution Diprosalic Solution Vehicle
    Started
    75
    77
    73
    Completed
    72
    74
    69
    Not completed
    3
    3
    4
         Technical-logistic reasons
    1
    -
    -
         Lack of efficacy
    -
    1
    3
         Pregnancy
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    1
         Low cortisol values
    -
    1
    -
         Lost to follow-up
    1
    -
    -
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject
    Blinding implementation details
    No treatment in the follow-up period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BetaSal Solution
    Arm description
    Test product
    Arm type
    Experimental

    Investigational medicinal product name
    Betamethasone 0.05%_Salicylic Acid 2% Solution
    Investigational medicinal product code
    D07XC01
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice per day. Total dose depends on the extent of the area to be treated.

    Arm title
    Diprosalic Solution
    Arm description
    Reference product
    Arm type
    Active comparator

    Investigational medicinal product name
    Diprosalic
    Investigational medicinal product code
    D07XC01
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice per day. Total dose depends on the extent of the area to be treated.

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Twice per day. Total amount depends on the area to be treated.

    Number of subjects in period 2
    BetaSal Solution Diprosalic Solution Vehicle
    Started
    72
    74
    69
    Completed
    70
    71
    62
    Not completed
    2
    3
    7
         Lack of efficacy
    -
    1
    5
         Consent withdrawn by subject
    1
    1
    -
         Lost to follow-up
    1
    1
    2

    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
    225 225
    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)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
        Adults (18 years and above)
    225 225
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    55.7 (20 to 92) -
    Gender categorical
    Total number of subjects
    Units: Subjects
        Female
    137 137
        Male
    88 88
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    includes all patients of the safety data who comply with the study diagnosis (according to the associated inclusion criterion) and provide the baseline value and at least one post baseline value under treatment

    Subject analysis set title
    PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    includes all patients of the ITT data set who do not exhibit any major protocol violations

    Subject analysis set title
    Safety data
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once

    Subject analysis sets values
    ITT PP Safety data
    Number of subjects
    225
    210
    225
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
        Adults (18 years and above)
    225
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    55.7 (20 to 92)
    Gender categorical
    Total number of subjects
    Units: Subjects
        Female
    137
    126
    137
        Male
    88
    84
    88

    End points

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    End points reporting groups
    Reporting group title
    BetaSal Solution
    Reporting group description
    Test product

    Reporting group title
    Diprosalic Solution
    Reporting group description
    Reference product

    Reporting group title
    Vehicle
    Reporting group description
    -
    Reporting group title
    BetaSal Solution
    Reporting group description
    Test product

    Reporting group title
    Diprosalic Solution
    Reporting group description
    Reference product

    Reporting group title
    Vehicle
    Reporting group description
    -

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    includes all patients of the safety data who comply with the study diagnosis (according to the associated inclusion criterion) and provide the baseline value and at least one post baseline value under treatment

    Subject analysis set title
    PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    includes all patients of the ITT data set who do not exhibit any major protocol violations

    Subject analysis set title
    Safety data
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    comprises all patients who had administered the study medication at least once

    Primary: Treatment effect

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    End point title
    Treatment effect
    End point description
    change of the sum score, defined as the sum of the score values of the individual activity parameters erythema, desquamation, thickening and pruritus, calculated as "value at visit 1 minus value at visit 4"
    End point type
    Primary
    End point timeframe
    start of treatment (visit 1) and end of treatment (visit 4)
    End point values
    BetaSal Solution Diprosalic Solution Vehicle
    Number of subjects analysed
    68
    71
    71
    Units: sum score values
        median (full range (min-max))
    6 (1 to 11)
    6 (-1 to 11)
    2 (-2 to 10)
    Statistical analysis title
    Analysis of efficacy
    Statistical analysis description
    Non-inferiority test (one-sided test) with alpha = 2.5% (t-test model) and beta = 20%, based on the PP data set. The Non-Inferiority limit was set to 1.5
    Comparison groups
    Diprosalic Solution v BetaSal Solution
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    0.35
    Confidence interval
         level
    97.5%
         sides
    1-sided
         lower limit
    -0.36
         upper limit
    -

    Other pre-specified: Superiority of Test over Vehicle

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    End point title
    Superiority of Test over Vehicle [1]
    End point description
    change of the sum score, defined as the sum of the score values of the individual activity parameters erythema, desquamation, thickening and pruritus, calculated as "value at visit 1 minus value at visit 4"
    End point type
    Other pre-specified
    End point timeframe
    start of treatment (visit 1) and end of treatment (visit 4)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis for this end point served as verification of the assay sensitivity and had to be done individually for each active preparation in accordance with CPMP/EWP/908/99.
    End point values
    BetaSal Solution Vehicle
    Number of subjects analysed
    75
    73
    Units: sum score values
        number (not applicable)
    5.9
    2.27
    Statistical analysis title
    Sensitivity analysis
    Statistical analysis description
    Superiority of Test over Vehicle for the primary efficacy variable
    Comparison groups
    BetaSal Solution v Vehicle
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Other pre-specified: Superiority of Reference over Vehicle

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    End point title
    Superiority of Reference over Vehicle [2]
    End point description
    change of the sum score, defined as the sum of the score values of the individual activity parameters erythema, desquamation, thickening and pruritus, calculated as "value at visit 1 minus value at visit 4"
    End point type
    Other pre-specified
    End point timeframe
    start of treatment (visit 1) and end of treatment (visit 4)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The statistical analysis for this end point served as verification of the assay sensitivity and had to be done individually for each active preparation in accordance with CPMP/EWP/908/99.
    End point values
    Diprosalic Solution Vehicle
    Number of subjects analysed
    77
    73
    Units: sum score values
        number (not applicable)
    5.37
    2.29
    Statistical analysis title
    Sensitivity analysis
    Comparison groups
    Diprosalic Solution v Vehicle
    Number of subjects included in analysis
    150
    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 the inclusion visit (visit 0) to the final visit (visit 5)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    BetaSal Solution
    Reporting group description
    Treatment arm with test product

    Reporting group title
    Diprosalic Solution
    Reporting group description
    Treatment arm with reference product

    Reporting group title
    Vehicle
    Reporting group description
    Treatment arm with placebo

    Serious adverse events
    BetaSal Solution Diprosalic Solution Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 75 (0.00%)
    2 / 77 (2.60%)
    0 / 73 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection staphylococcal
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    BetaSal Solution Diprosalic Solution Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 75 (16.00%)
    10 / 77 (12.99%)
    13 / 73 (17.81%)
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    1
    2
    0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 75 (1.33%)
    2 / 77 (2.60%)
    0 / 73 (0.00%)
         occurrences all number
    1
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Blood cortisol increased
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    1
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    0
    2
    Application site pruritus
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    Application site dryness
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis noninfective
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    Hyperkeratosis
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Skin tightness
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    Eczema
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Rosacea
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Skin burning sensation
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    0
    Polymorphic light eruption
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Trigger finger
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 75 (2.67%)
    1 / 77 (1.30%)
    2 / 73 (2.74%)
         occurrences all number
    2
    1
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 75 (0.00%)
    1 / 77 (1.30%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    1 / 73 (1.37%)
         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 reported
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