Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37212   clinical trials with a EudraCT protocol, of which   6120   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Safety and Efficacy of Calcipotriol plus Betamethasone Dipropionate Gel in Adolescent Patients (Aged 12 to 17 Years) with Scalp Psoriasis

    Summary
    EudraCT number
    2008-005456-24
    Trial protocol
    FR   GB  
    Global end of trial date
    15 Oct 2012

    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

    Close Top of page
    Trial identification
    Sponsor protocol code
    MBL 0412 INT
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    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)
    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
    15 Oct 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the safety of once daily use of calcipotriol (50 mcg/g) plus betamethasone (0.5 mg/g) (as dipropionate) gel in adolescent subjects (aged 12 to 17 years) with scalp psoriasis.
    Protection of trial subjects
    Not applicable
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Nov 2010
    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
    United Kingdom: 37
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    France: 22
    Worldwide total number of subjects
    78
    EEA total number of subjects
    59
    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)
    78
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    LEO 80185 Gel Once Daily Application
    Arm description
    Talconex® Scalp Topical Suspension/Daivobet® gel/Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 weeks to treat psoriasis on the scalp.
    Arm type
    Experimental

    Investigational medicinal product name
    LEO 80185 gel, calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
    Investigational medicinal product code
    Other name
    LEO 80185 gel
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Applied once daily to lesions on the scalp, for up to 8 weeks

    Number of subjects in period 1
    LEO 80185 Gel Once Daily Application
    Started
    78
    Completed
    74
    Not completed
    4
         Adverse event, non-fatal
    1
         Exclusion criteria emerging
    2
         Other reason(s)
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    LEO 80185 Gel Once Daily Application
    Reporting group description
    Talconex® Scalp Topical Suspension/Daivobet® gel/Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 weeks to treat psoriasis on the scalp.

    Reporting group values
    LEO 80185 Gel Once Daily Application Total
    Number of subjects
    78 78
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    78 78
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.6 ± 1.7 -
    Gender categorical
    Units: Subjects
        Female
    43 43
        Male
    35 35

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    LEO 80185 Gel Once Daily Application
    Reporting group description
    Talconex® Scalp Topical Suspension/Daivobet® gel/Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 weeks to treat psoriasis on the scalp.

    Primary: Percentage of Subjects with Adverse Drug Reactions (ADRs)

    Close Top of page
    End point title
    Percentage of Subjects with Adverse Drug Reactions (ADRs) [1]
    End point description
    Adverse events for which the investigator did not describe the causal relationship to IP as not related
    End point type
    Primary
    End point timeframe
    Throughout trial, up to 8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Percent subjects
        number (not applicable)
    6.4
    No statistical analyses for this end point

    Primary: Change in Albumin-corrected Serum Calcium From Baseline to Week 4

    Close Top of page
    End point title
    Change in Albumin-corrected Serum Calcium From Baseline to Week 4 [2]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 4
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    77
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.014 ± 0.139
    No statistical analyses for this end point

    Primary: Change in Albumin-corrected Serum Calcium From Baseline to Week 8

    Close Top of page
    End point title
    Change in Albumin-corrected Serum Calcium From Baseline to Week 8 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Basline and week 8
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    60
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.002 ± 0.098
    No statistical analyses for this end point

    Primary: Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment

    Close Top of page
    End point title
    Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment [4]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and End of treatment (up to 8 weeks)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: mmol/L
        arithmetic mean (standard deviation)
    0 ± 0.101
    No statistical analyses for this end point

    Primary: Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4

    Close Top of page
    End point title
    Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and week 4
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    76
    Units: mmol/24hr
        arithmetic mean (standard deviation)
    -0.01 ± 1.54
    No statistical analyses for this end point

    Primary: Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8

    Close Top of page
    End point title
    Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 [6]
    End point description
    End point type
    Primary
    End point timeframe
    Basline and week 8
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    60
    Units: mmol/24hr
        arithmetic mean (standard deviation)
    0.03 ± 1.42
    No statistical analyses for this end point

    Primary: Change in 24-hour Urinary Calcium Excretion from Baseline to End of Treatment

    Close Top of page
    End point title
    Change in 24-hour Urinary Calcium Excretion from Baseline to End of Treatment [7]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and End of Treatment (up to 8 weeks)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    77
    Units: mmol/24hr
        arithmetic mean (standard deviation)
    -0.03 ± 1.43
    No statistical analyses for this end point

    Primary: Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment

    Close Top of page
    End point title
    Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment [8]
    End point description
    End point type
    Primary
    End point timeframe
    Basline and End of Treatment
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no formal statistical hypothesis to be evaluated. The data were summarised using descriptive statistics.
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    77
    Units: mmol/g
        arithmetic mean (standard deviation)
    -0.1156 ± 1.679
    No statistical analyses for this end point

    Secondary: Change in Plasma parathyroid hormone (PTH) From Baseline to Week 4

    Close Top of page
    End point title
    Change in Plasma parathyroid hormone (PTH) From Baseline to Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and week 4
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    74
    Units: ng/L
        arithmetic mean (standard deviation)
    1.2 ± 16
    No statistical analyses for this end point

    Secondary: Change in Plasma PTH From Baseline to Week 8

    Close Top of page
    End point title
    Change in Plasma PTH From Baseline to Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and week 8
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    61
    Units: ng/L
        arithmetic mean (standard deviation)
    -2.8 ± 13
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (i.e. Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2

    Close Top of page
    End point title
    Subjects With Controlled Disease (i.e. Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2
    End point description
    Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    37
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 4

    Close Top of page
    End point title
    Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 4
    End point description
    Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    59
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 8

    Close Top of page
    End point title
    Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 8
    End point description
    Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    61
    Units: Participants
        number (not applicable)
    49
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at End of Treatment

    Close Top of page
    End point title
    Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at End of Treatment
    End point description
    Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment
    End point type
    Secondary
    End point timeframe
    End of Treatment (up to 8 weeks)
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    66
    No statistical analyses for this end point

    Secondary: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2

    Close Top of page
    End point title
    Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2
    End point description
    Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 2
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Percentage of change
        arithmetic mean (standard deviation)
    -62.7 ± 22.3
    No statistical analyses for this end point

    Secondary: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4

    Close Top of page
    End point title
    Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4
    End point description
    Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.
    End point type
    Secondary
    End point timeframe
    Baseline and week 4
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Percent of change
        arithmetic mean (standard deviation)
    72.1 ± 21.4
    No statistical analyses for this end point

    Secondary: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8

    Close Top of page
    End point title
    Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8
    End point description
    Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
    End point type
    Secondary
    End point timeframe
    Baseline and week 8
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    61
    Units: Percent change
        arithmetic mean (standard deviation)
    -76.6 ± 23.5
    No statistical analyses for this end point

    Secondary: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.

    Close Top of page
    End point title
    Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.
    End point description
    Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (up to 8 weeks)
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Percent of change
        arithmetic mean (standard deviation)
    80.4 ± 22.6
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 2

    Close Top of page
    End point title
    Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 2
    End point description
    Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    44
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 4

    Close Top of page
    End point title
    Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 4
    End point description
    Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    55
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 8

    Close Top of page
    End point title
    Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 8
    End point description
    Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    61
    Units: Participants
        number (not applicable)
    51
    No statistical analyses for this end point

    Secondary: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at End of Treatment

    Close Top of page
    End point title
    Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at End of Treatment
    End point description
    Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.
    End point type
    Secondary
    End point timeframe
    End of Treatment (up to 8 weeks)
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    68
    No statistical analyses for this end point

    Secondary: Withdrawal

    Close Top of page
    End point title
    Withdrawal
    End point description
    How many subjects withdrew from the study. Reasons for withdrawal: due to exclusion criteria emerging, due to AE(s), or due to other reason
    End point type
    Secondary
    End point timeframe
    Week 4 and 8
    End point values
    LEO 80185 Gel Once Daily Application
    Number of subjects analysed
    78
    Units: Participants
        number (not applicable)
    4
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Throughout the trial, up to 8 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    LEO 80185 Gel Once Daily Application
    Reporting group description
    Talconex® Scalp Topical Suspension/Daivobet® gel/Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 weeks to treat psoriasis on the scalp.

    Serious adverse events
    LEO 80185 Gel Once Daily Application
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 78 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    LEO 80185 Gel Once Daily Application
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 78 (12.82%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    5
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jun 2010
    The duration of the wash-out period extended to up to 8 weeks (were up to 5 weeks), making the maximum duration of the trial period for each subject 20 weeks (were 17 weeks). Informed consent for minors that became legally emancipated was added, so that a subject, who previously gave assent, during the trial became legally emancipated was to be asked to provide their written consent.
    11 Aug 2010
    In the instruction to the Treatment Period the following was added: ‘Subjects should be instructed to discontinue treatment on individual lesions if/when a lesion has cleared’. The following calculations from the 24-hour urine sample were added: calcium:creatinine, phophate:creatinine, hydroxyproline:creatinine, and sodium:creatinine ratios. The wording of the definition of clear in erythema was clarified. Cortisol was added to the biochemistry assessment.
    05 Jan 2011
    Canada was added as a country. Inclusion Criterion No. 6 was amended to ‘Clinical diagnosis of psoriasis vulgaris as evidenced by scalp psoriasis lesions of typical appearance or clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs.’ Inclusion Criterion No. 8 was amended to ‘Attending a hospital out-patient clinic or the private practice of a dermatologist or in the UK a General Practitioner with Special Interest in Dermatology (GPwSI).’ .
    21 Nov 2011
    The number of sites to include subjects were changed to 36 sites and Germany was added as a country (although no sites in Germany were used). Exclusion Criterion No. 16 was amended to ‘Any clinically significant abnormality following review of screening laboratory tests (blood and spot urine samples, not including 24-hour urine sample), physical examination or blood pressure/heart rate measurement performed at SV2.’ ). An Exclusion Criterion No. 23 was added: ‘Subjects who are institutionalised by court order or by the local authority.’ `The following were to be analysed quantitatively in the 24-hour urine sample: ` was added

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA