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    Clinical Trial Results:
    A phase II trial to evaluate the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis - parallel group comparison

    Summary
    EudraCT number
    2013-004519-28
    Trial protocol
    DE  
    Global end of trial date
    15 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Aug 2016
    First version publication date
    17 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H573000-1307
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Almirall Hermal GmbH
    Sponsor organisation address
    Scholtzstraße 3, Reinbek, Germany, 21465
    Public contact
    Disclosure Central Team, ALMIRALL S.A., R&D@almirall.com
    Scientific contact
    Disclosure Central Team, ALMIRALL S.A., R&D@almirall.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
    15 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to assess the anti-psoriatic efficacy and tolerability of tazarotene in a gel formulation in patients with mild to moderate nail psoriasis compared to the vehicle
    Protection of trial subjects
    The clinical trial was conducted in compliance with globally accepted standards of good clinical practice (as defined in the ICH E6 guideline for good clinical practice, January 1997), in agreement with the Declaration of Helsinki (Seoul, October 2008) and in keeping with German regulations
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Feb 2014
    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: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    64
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a multicentre trial conducted in 6 centres in Germany. First patient visit was in February 2014 and last patient visit was in May 2015

    Pre-assignment
    Screening details
    During a 4-week screening phase, 85 patients were screened and there were 19 screening failures

    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
    LAS41006
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Tazarotene
    Investigational medicinal product code
    LAS41006
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    LAS41006 (0.1%) or vehicle gel was topically applied with up to 40 mg gel to each of the affected fingernails (approximately 1–4 cm2, each) once daily over night to each affected fingernail (at least one) during a 12-week treatment period (84 applications). Maximum daily dosage was approximately 0.4 mg tazarotene (in case all 10 fingernails affected and treated) Immediately after each application the respective fingernail was covered with a semi-occlusive plaster overnight

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    LAS41006 (0.1%) or vehicle gel was topically applied with up to 40 mg gel to each of the affected fingernails (approximately 1–4 cm2, each) once daily over night to each affected fingernail (at least one) during a 12-week treatment period (84 applications) Immediately after each application the respective fingernail was covered with a semi-occlusive plaster overnight

    Number of subjects in period 1
    LAS41006 Placebo
    Started
    34
    32
    Completed
    28
    27
    Not completed
    6
    5
         Consent withdrawn by subject
    5
    4
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LAS41006
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    LAS41006 Placebo Total
    Number of subjects
    34 32 66
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    33 31 64
        From 65-84 years
    1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49 ± 13 51.4 ± 10 -
    Gender categorical
    Units: Subjects
        Female
    9 14 23
        Male
    25 18 43

    End points

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    End points reporting groups
    Reporting group title
    LAS41006
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Percentage change from baseline in mNAPSI of the target fingernail

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    End point title
    Percentage change from baseline in mNAPSI of the target fingernail
    End point description
    mNAPSI was a measure of severity of psoriasis affecting a target nail. The 4 quadrants of the target fingernail were assessed separately by 8 parameters - 4 reflecting nail matrix involvement (pitting, leukonychia, red spotted lunula, and plate crumbling) and 4 reflecting nail bed involvement (onycholysis, subungual hyperkeratosis, oil drops [salmon patches], and splinter haemorrhages) - using a scale of 0 (= none) to 3 (= severe) The mNAPSI, defined as the sum of all 8 parameters in each of the 4 quadrants of the target nail, lay between 0 and 96
    End point type
    Primary
    End point timeframe
    Day 85 (End of Treatment)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32
    32
    Units: Percentage
        arithmetic mean (standard deviation)
    -14.7 ± 39.3
    -33 ± 36.6
    Statistical analysis title
    LAS41006 v Placebo
    Comparison groups
    LAS41006 v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0573
    Method
    t-test, 2-sided
    Parameter type
    Mean difference (final values)
    Point estimate
    18.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.6
         upper limit
    37.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.5

    Secondary: Change from baseline in mNAPSI

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    End point title
    Change from baseline in mNAPSI
    End point description
    mNAPSI was a measure of severity of psoriasis affecting a target nail. The 4 quadrants of the target fingernail were assessed separately by 8 parameters - 4 reflecting nail matrix involvement (pitting, leukonychia, red spotted lunula, and plate crumbling) and 4 reflecting nail bed involvement (onycholysis, subungual hyperkeratosis, oil drops [salmon patches], and splinter haemorrhages) - using a scale of 0 (= none) to 3 (= severe) The mNAPSI, defined as the sum of all 8 parameters in each of the 4 quadrants of the target nail, lay between 0 and 96
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32 [1]
    32 [2]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    17.4 ± 5.3
    16.5 ± 3.9
        Day 15
    -0.5 ± 2.7
    -2.5 ± 3.9
        Day 29
    -1.7 ± 3.9
    -3.6 ± 5.5
        Day 57
    -3 ± 5.7
    -5.1 ± 6.9
        Day 85 (end of treatment)
    -2.6 ± 6.5
    -5.4 ± 6.5
        Day 169 (follow-up)
    -3.6 ± 5.5
    -5.3 ± 6.8
    Notes
    [1] - At Day 169, N=28
    [2] - At Day 169, N=27
    No statistical analyses for this end point

    Secondary: Percentage of mNAPSI-50 and -75 responders

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    End point title
    Percentage of mNAPSI-50 and -75 responders
    End point description
    mNAPSI was a measure of severity of psoriasis affecting a target nail. The 4 quadrants of the target fingernail were assessed separately by 8 parameters - 4 reflecting nail matrix involvement (pitting, leukonychia, red spotted lunula, and plate crumbling) and 4 reflecting nail bed involvement (onycholysis, subungual hyperkeratosis, oil drops [salmon patches], and splinter haemorrhages) - using a scale of 0 (= none) to 3 (= severe) The mNAPSI, defined as the sum of all 8 parameters in each of the 4 quadrants of the target nail, lay between 0 and 96 mNAPSI-50, mNAPSI-75 and mNAPSI-90 defined as proportion of patients achieving an improvement of ≥50%, ≥75% and ≥90%, respectively, in % change in mNAPSI
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32 [3]
    32 [4]
    Units: Percentage
        mNAPSI-50 Day 15
    0
    13
        mNAPSI-50 Day 29
    9
    22
        mNAPSI-50 Day 57
    16
    28
        mNAPSI-50 Day 85 (end of treatment)
    25
    34
        mNAPSI-50 Day 169 (follow-up)
    18
    37
        mNAPSI-75 Day 15
    0
    0
        mNAPSI-75 Day 29
    0
    6
        mNAPSI-75 Day 57
    6
    16
        mNAPSI-75 Day 85 (end of treatment)
    6
    16
        mNAPSI-75 Day 169 (follow-up)
    4
    15
    Notes
    [3] - On Day 169, N=28
    [4] - On Day 169, N=27
    No statistical analyses for this end point

    Secondary: Percentage of mNAPSI-90 responders

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    End point title
    Percentage of mNAPSI-90 responders
    End point description
    mNAPSI was a measure of severity of psoriasis affecting a target nail. The 4 quadrants of the target fingernail were assessed separately by 8 parameters - 4 reflecting nail matrix involvement (pitting, leukonychia, red spotted lunula, and plate crumbling) and 4 reflecting nail bed involvement (onycholysis, subungual hyperkeratosis, oil drops [salmon patches], and splinter hemorrhages) - using a scale of 0 (= none) to 3 (= severe) The mNAPSI, defined as the sum of all 8 parameters in each of the 4 quadrants of the target nail, lay between 0 and 96 mNAPSI-50, mNAPSI-75 and mNAPSI-90 defined as proportion of patients achieving an improvement of ≥50%, ≥75% and ≥90%, respectively, in % change in mNAPSI
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32 [5]
    32 [6]
    Units: Percentage
        mNAPSI-90 Day 15
    0
    0
        mNAPSI-90 Day 29
    0
    0
        mNAPSI-90 Day 57
    0
    3
        mNAPSI-90 Day 85 (end of treatment)
    0
    9
        mNAPSI-90 Day 169 (follow-up)
    0
    7
    Notes
    [5] - On Day 169, N=28
    [6] - On Day 169, N=28
    No statistical analyses for this end point

    Secondary: Change from baseline in mNAPSI nail bed total scores

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    End point title
    Change from baseline in mNAPSI nail bed total scores
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32 [7]
    32 [8]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    8.8 ± 3.5
    9.2 ± 3.4
        Day 15
    -0.3 ± 1.9
    -1.7 ± 2.8
        Day 29
    -1.3 ± 2.8
    -1.9 ± 3.9
        Day 57
    -1.4 ± 3.8
    -2.9 ± 4.5
        Day 85 (end of treatment)
    -1.4 ± 4.9
    -2.1 ± 5
        Day 169 (follow-up)
    -1.8 ± 3.7
    -2.2 ± 5.1
    Notes
    [7] - At Day 169, N=28
    [8] - At Day 169, N=27
    No statistical analyses for this end point

    Secondary: Change from baseline in mNAPSI nail matrix bed total scores

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    End point title
    Change from baseline in mNAPSI nail matrix bed total scores
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32 [9]
    32 [10]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    8.6 ± 6.1
    7.3 ± 4.9
        Day 15
    -0.2 ± 1.7
    -0.8 ± 1.9
        Day 29
    -0.4 ± 2.6
    -1.7 ± 3
        Day 57
    -1.6 ± 3.6
    -2.2 ± 2.9
        Day 85 (end of treatment)
    -1.2 ± 3.3
    -2.7 ± 3.4
        Day 169 (follow-up)
    -1.8 ± 3.7
    -3.1 ± 4.2
    Notes
    [9] - At Day 169, N=28
    [10] - At Day 169, N=27
    No statistical analyses for this end point

    Secondary: Change from baseline in NAPSI of all 10 fingernails (including target fingernail)

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    End point title
    Change from baseline in NAPSI of all 10 fingernails (including target fingernail)
    End point description
    The NAPSI assessed the presence of nail matrix (pitting, leukonychia, red spotted lunula, or plate crumbling) and nail bed (onycholysis, subungual hyperkeratosis, oil drops [salmon patches], or splinter hemorrhages) involvement in each quadrant of all 10 fingernails The NAPSI total score was defined as the total number of involved quadrants of all 10 fingernails of the nail matrix and nail bed assessments, ranging from 0 to 80
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32 [11]
    32 [12]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    35.7 ± 14
    34.6 ± 14.6
        Day 15
    -0.1 ± 2.6
    -1.9 ± 5.6
        Day 29
    -0.8 ± 4.7
    -2.3 ± 9.7
        Day 57
    -1.3 ± 5.8
    -3.4 ± 11.3
        Day 85 (end of treatment)
    -0.3 ± 6.2
    -3.4 ± 12.8
        Day 169 (follow-up)
    -1 ± 7.7
    -3.3 ± 11.4
    Notes
    [11] - On Day 169, N=28
    [12] - On Day 169, N=27
    No statistical analyses for this end point

    Secondary: Change from baseline in NAPPA-QOL global score

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    End point title
    Change from baseline in NAPPA-QOL global score
    End point description
    NAPPA-QOL was a 20-item nail-specific quality of life questionnaire which assesses specific quality of life conditions in the past week Answers were given in Likert scales from 0 to 4: 0 = ‘not at all’; 1 = ‘somewhat’; 2 = ‘moderately’; 3 = ‘quite’; 4 = ‘very’ The NAPPA-QOL global score was determined as average of the 20 items
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    31 [13]
    31 [14]
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    1.53 ± 0.62
    1.56 ± 0.8
        Day 15
    -0.35 ± 0.43
    -0.31 ± 0.43
        Day 29
    -0.42 ± 0.48
    -0.38 ± 0.46
        Day 57
    -0.47 ± 0.58
    -0.39 ± 0.48
        Day 85 (end of treatment)
    -0.46 ± 0.62
    -0.43 ± 0.63
        Day 169 (follow-up)
    -0.4 ± 0.52
    -0.36 ± 0.63
    Notes
    [13] - On Day 169, N=28
    [14] - On Day 169, N=27
    No statistical analyses for this end point

    Secondary: NAPPA-PBI global score

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    End point title
    NAPPA-PBI global score
    End point description
    The NAPPA-PBI global score, an importance-weighted sum of 24 benefit scores The weights were derived from patient defined needs as assessed in a 24-item questionnaire at baseline
    End point type
    Secondary
    End point timeframe
    Day 85 (end of treatment) and Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    31 [15]
    28 [16]
    Units: Score
    arithmetic mean (standard deviation)
        Day 85 (end of treatment)
    0.56 ± 0.85
    0.71 ± 0.91
        Day 169 (follow-up)
    0.72 ± 0.88
    0.83 ± 0.93
    Notes
    [15] - On Day 169, N=28
    [16] - On Day 169, N=25
    No statistical analyses for this end point

    Secondary: Change from baseline in NAPPA-CLIN

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    End point title
    Change from baseline in NAPPA-CLIN
    End point description
    NAPPA-CLIN has been developed from the NAPSI score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 8 criteria for each nail The NAPPA-CLIN is a simplified version of the NAPSI. In this trial it only assessed the least and the worst involved fingernail of both hands. Thus, the NAPPA-CLIN score for hands, as the sum of the least and the worst involvement, ranged from 0 to 16 empirically
    End point type
    Secondary
    End point timeframe
    Up to Day 169 (follow-up)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32
    32
    Units: Score
    arithmetic mean (standard deviation)
        Baseline
    8.1 ± 2.2
    7.8 ± 2.3
        Day 15
    0.1 ± 1.5
    -0.1 ± 1.4
        Day 29
    -0.2 ± 1.9
    -0.6 ± 2.2
        Day 57
    -0.3 ± 2
    -0.7 ± 2.4
        Day 85 (end of treatment)
    0 ± 1.4
    -0.5 ± 2.7
    No statistical analyses for this end point

    Secondary: Physician's global assessment score

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    End point title
    Physician's global assessment score
    End point description
    End point type
    Secondary
    End point timeframe
    Day 85 (end of treatment)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    32
    31
    Units: Percentage
        0 = cure
    0
    0
        1 = almost clear
    0
    16
        2 = visible signs
    19
    29
        3 = distinctly visible, marked signs
    81
    55
    No statistical analyses for this end point

    Secondary: Patient's global assessment score

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    End point title
    Patient's global assessment score
    End point description
    Patient’s global assessment of efficacy performed as average over all treated fingernails
    End point type
    Secondary
    End point timeframe
    Day 85 (end of treatment)
    End point values
    LAS41006 Placebo
    Number of subjects analysed
    31
    31
    Units: Percentage
        0 = very good
    0
    3
        1 = good
    13
    16
        2 = acceptable
    16
    16
        3 = poor
    71
    65
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 169 (follow-up) ±7 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    LAS41006
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    LAS41006 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 32 (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: 5%
    Non-serious adverse events
    LAS41006 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 32 (6.25%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 34 (2.94%)
    2 / 32 (6.25%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Aug 2014
    Inclusion of two further trial centres in the trial conduct to recruit more patients and changes of protocol sections necessary for clarification and better readability

    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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