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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Topically Applied DGLA Cream in Patients with Mild to Moderate Atopic Dermatitis

    Summary
    EudraCT number
    		 2012-003739-44
    Trial protocol
    		 FI   SE   HU   DK   BG  
    Global end of trial date
    13 Jan 2014

    Results information
    Results version number
    		 v1
    This version publication date
    25 Apr 2022
    First version publication date
    25 Apr 2022
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    DS107E-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Afimmune
    Sponsor organisation address
    Trintech Building, South County Business Park, Dublin, Ireland, Dublin 18
    Public contact
    Study Director, Dignity Sciences Limited, +353 1 2933 590, dsbiopharma.regulatory@dsbiopharma.com
    Scientific contact
    Study Director, Dignity Sciences Limited, +353 1 2933 590, dsbiopharma.regulatory@dsbiopharma.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
    26 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: To compare the effectiveness of three doses of topically applied DGLA cream, versus placebo, in the treatment of adult patients with mild to moderate atopic dermatitis. Secondary: To assess the safety, tolerability and the bioavailability of three doses of topically applied DGLA cream versus placebo, in patients with mild to moderate atopic dermatitis.
    Protection of trial subjects
    The study was managed and conducted according to the World Medical Association Declaration of Helsinki 1964, the latest International Conference on Harmonisation (ICH) guidelines for Good Clinical Practice (GCP) and applicable regulatory requirement(s) (specifically the principles of GCP in ICH topic E6, as laid down by the Commission Directive 2005/28/EC and in accordance with applicable local laws and guidelines).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2013
    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
    Bulgaria: 52
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    Finland: 49
    Country: Number of subjects enrolled
    Hungary: 89
    Worldwide total number of subjects
    203
    EEA total number of subjects
    203
    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)
    193
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a randomized, placebo-controlled, double-blind, parallel group, multi-centre Phase II study.

    Pre-assignment
    Screening details
    		 The study consisted of a wash-out period of 14 days, for patients who were currently receiving treatment for their atopic dermatitis at the Screening visit; a 28 day treatment period and a 7 day follow up period.

    Period 1
    Period 1 title
    Overall Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DS107E DGLA 0.1% Cream
    Arm description
    		 DS107E DGLA 0.1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DS107 Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    DS107E DGLA 0.1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Arm title
    		 DS107E DGLA 1% cream
    Arm description
    		 DS107E DGLA 1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DS107 Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    DS107E DGLA 1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Arm title
    		 DS107E DGLA 5% cream
    Arm description
    		 DS107E DGLA 5% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DS107 Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    DS107E DGLA 5% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Arm title
    		 DS107E Placebo cream
    Arm description
    		 DS107E Placebo cream applied topically to all affected or commonly affected areas twice-daily for 28 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching DS107 Placebo Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    DS107E Placebo cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Number of subjects in period 1
    		DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Started
    49
    52
    51
    51
    Completed
    46
    49
    48
    47
    Not completed
    3
    3
    3
    4
         Consent withdrawn by subject
    -
    -
    1
    2
         Adverse event, non-fatal
    -
    -
    1
    -
         Lost to follow-up
    2
    -
    -
    -
         Disease Progression
    1
    2
    -
    1
         Protocol deviation
    -
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DS107E DGLA 0.1% Cream
    Reporting group description
    		 DS107E DGLA 0.1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E DGLA 1% cream
    Reporting group description
    		 DS107E DGLA 1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E DGLA 5% cream
    Reporting group description
    		 DS107E DGLA 5% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E Placebo cream
    Reporting group description
    		 DS107E Placebo cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream Total
    Number of subjects
    		 49 52 51 51 203
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 46 50 47 50 193
        From 65-84 years
    		 3 2 4 1 10
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.7 ( 15.4 ) 34.2 ( 14.6 ) 34.5 ( 16.6 ) 34.5 ( 13.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 37 36 36 136
        Male
    		 22 15 15 15 67
    Ethnicity
    Units: Subjects
        Caucasian
    		 48 52 51 51 202
        Other
    		 1 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    DS107E DGLA 0.1% Cream
    Reporting group description
    		 DS107E DGLA 0.1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E DGLA 1% cream
    Reporting group description
    		 DS107E DGLA 1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E DGLA 5% cream
    Reporting group description
    		 DS107E DGLA 5% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E Placebo cream
    Reporting group description
    		 DS107E Placebo cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Primary: Change in modified Eczema Area and Severity Index (mEASI) from baseline (Day 0/start of IMP treatment) to 28 days (end of treatment) to evaluate the efficacy of three doses of topically applied DGLA cream in comparison to placebo.

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    End point title
    		 Change in modified Eczema Area and Severity Index (mEASI) from baseline (Day 0/start of IMP treatment) to 28 days (end of treatment) to evaluate the efficacy of three doses of topically applied DGLA cream in comparison to placebo.
    End point description
    Change in modified Eczema Area and Severity Index (mEASI) from baseline (Day 0/start of IMP treatment) to 28 days (end of treatment) to evaluate the efficacy of three doses of topically applied DGLA cream in comparison to placebo.
    End point type
    Primary
    End point timeframe
    Up to 28 days.
    End point values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Number of subjects analysed
    49
    52
    51
    50
    Units: mEASI Scores
        arithmetic mean (standard deviation)
    -1.86 ( 5.34 )
    -2.87 ( 4.23 )
    -2.83 ( 4.68 )
    -3.96 ( 7.11 )
    Statistical analysis title
    		 DGLA V Placebo
    Comparison groups
    DS107E DGLA 0.1% Cream v DS107E DGLA 1% cream v DS107E DGLA 5% cream v DS107E Placebo cream
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3086
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.86534534
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8064781
         upper limit
    		 2.53716879

    Secondary: Change in modified Eczema Area and Severity Index (mEASI) from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14 and 21 days.

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    End point title
    		 Change in modified Eczema Area and Severity Index (mEASI) from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14 and 21 days.
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 21 days.
    End point values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Number of subjects analysed
    49
    52
    51
    50
    Units: mEASI Scores
    arithmetic mean (standard deviation)
        Baseline to Day 7
    -0.82 ( 2.84 )
    -1.09 ( 3.31 )
    -0.57 ( 2.53 )
    -0.03 ( 3.73 )
        Baseline to Day 14
    -1.59 ( 3.97 )
    -1.89 ( 3.59 )
    -2.29 ( 2.84 )
    -2.37 ( 4.29 )
        Baseline to Day 21
    -2.31 ( 3.87 )
    -2.49 ( 3.83 )
    -2.83 ( 3.31 )
    -3.98 ( 4.81 )
    No statistical analyses for this end point

    Secondary: Change in Investigator’s Global Assessment (IGA) score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

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    End point title
    		 Change in Investigator’s Global Assessment (IGA) score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point description
    Change in Investigator’s Global Assessment (IGA) score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point type
    Secondary
    End point timeframe
    Up to 28 days.
    End point values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Number of subjects analysed
    49
    52
    51
    50
    Units: IGA Scores
    arithmetic mean (standard deviation)
        Baseline to Day 7
    -0.2 ( 0.5 )
    -0.1 ( 0.6 )
    -0.0 ( 0.5 )
    0.0 ( 0.4 )
        Baseline to Day 14
    -0.3 ( 0.7 )
    -0.2 ( 0.7 )
    -0.3 ( 0.6 )
    -0.2 ( 0.6 )
        Baseline to Day 21
    -0.4 ( 0.8 )
    -0.3 ( 0.8 )
    -0.3 ( 0.5 )
    -0.5 ( 0.7 )
        Baseline to Day 28
    -0.4 ( 1.0 )
    -0.6 ( 0.9 )
    -0.5 ( 0.8 )
    -0.3 ( 1.0 )
    No statistical analyses for this end point

    Secondary: Change in the patient’s Visual Analogue Scale (VAS) pruritus score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

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    End point title
    		 Change in the patient’s Visual Analogue Scale (VAS) pruritus score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point description
    Change in the patient’s VAS pruritus score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point type
    Secondary
    End point timeframe
    Up to 28 days.
    End point values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Number of subjects analysed
    49
    52
    51
    50
    Units: VAS Pruritus Scores
    arithmetic mean (standard deviation)
        Baseline to Day 7
    -5.7 ( 19.8 )
    -7.2 ( 18.2 )
    -6.9 ( 17.7 )
    -1.5 ( 21.2 )
        Baseline to Day 14
    -7.0 ( 19.8 )
    -11.1 ( 21.4 )
    -12.3 ( 17.7 )
    -10.8 ( 22.1 )
        Baseline to Day 21
    -10.4 ( 24.2 )
    -15.1 ( 26.1 )
    -17.5 ( 21.9 )
    -19.6 ( 24.0 )
        Baseline to Day 28
    -15.0 ( 25.7 )
    -15.9 ( 26.9 )
    -20.0 ( 22.9 )
    -18.1 ( 30.4 )
    No statistical analyses for this end point

    Secondary: Change in the Patient Orientated Eczema Measure (POEM) from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

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    End point title
    		 Change in the Patient Orientated Eczema Measure (POEM) from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point description
    Change in the POEM from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point type
    Secondary
    End point timeframe
    Up to 28 days.
    End point values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Number of subjects analysed
    49
    52
    51
    50
    Units: POEM Scores
    arithmetic mean (standard deviation)
        Baseline to Day 7
    -1.5 ( 4.7 )
    -2.9 ( 4.7 )
    -2.1 ( 5.1 )
    -1.5 ( 3.4 )
        Baseline to Day 14
    -2.8 ( 5.7 )
    -3.6 ( 5.0 )
    -4.6 ( 4.6 )
    -3.4 ( 5.2 )
        Baseline to Day 21
    -3.9 ( 6.8 )
    -4.9 ( 5.7 )
    -5.1 ( 5.6 )
    -6.4 ( 5.3 )
        Baseline to Day 28
    -3.5 ( 6.7 )
    -4.8 ( 6.8 )
    -5.0 ( 6.2 )
    -5.5 ( 7.2 )
    No statistical analyses for this end point

    Secondary: Change in the Dermatology Life Quality Index (DLQI) score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.

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    End point title
    		 Change in the Dermatology Life Quality Index (DLQI) score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point description
    Change in the DLQI score from screening (Visit 1) to baseline (Visit 2) and from baseline to 7, 14, 21 and 28 days.
    End point type
    Secondary
    End point timeframe
    Up to 28 days.
    End point values
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Number of subjects analysed
    49
    52
    51
    50
    Units: DLQI Scores
    arithmetic mean (standard deviation)
        Baseline to Day 7
    -0.9 ( 2.4 )
    -1.8 ( 4.9 )
    -1.1 ( 3.7 )
    -1.2 ( 3.3 )
        Baseline to Day 14
    -1.8 ( 3.5 )
    -2.5 ( 4.4 )
    -3.2 ( 3.6 )
    -2.3 ( 5.1 )
        Baseline to Day 21
    -2.7 ( 4.2 )
    -4.0 ( 4.7 )
    -3.8 ( 3.9 )
    -4.2 ( 4.4 )
        Baseline to Day 28
    -2.4 ( 4.3 )
    -4.2 ( 5.5 )
    -3.6 ( 4.8 )
    -3.5 ( 5.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 35 days
    Adverse event reporting additional description
    An adverse event (AE) is any undesirable experience occurring to a patient that has signed the ICF, whether or not considered related to the investigational IMP(s). All Adverse Events must be recorded in the case report form, defining relationship to IMP and severity.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    DS107E DGLA 0.1% Cream
    Reporting group description
    		 DS107E DGLA 0.1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E DGLA 1% cream
    Reporting group description
    		 DS107E DGLA 1% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E DGLA 5% cream
    Reporting group description
    		 DS107E DGLA 5% cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Reporting group title
    DS107E Placebo cream
    Reporting group description
    		 DS107E Placebo cream applied topically to all affected or commonly affected areas twice-daily for 28 days.

    Serious adverse events
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DS107E DGLA 0.1% Cream DS107E DGLA 1% cream DS107E DGLA 5% cream DS107E Placebo cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 49 (57.14%)
    27 / 52 (51.92%)
    30 / 51 (58.82%)
    24 / 50 (48.00%)
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Application site dryness
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Application site erythema
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Application site irritation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Application site pain
         subjects affected / exposed
    1 / 49 (2.04%)
    5 / 52 (9.62%)
    4 / 51 (7.84%)
    2 / 50 (4.00%)
         occurrences all number
    1
    8
    4
    2
    Application site pruritus
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
         occurrences all number
    1
    6
    1
    3
    Application site reaction
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    2
    Application site urticaria
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Inflammation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nodule
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    3 / 51 (5.88%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    3
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    4 / 51 (7.84%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    4
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphocyte count increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    0
    1
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Headache
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    7 / 50 (14.00%)
         occurrences all number
    4
    2
    2
    11
    Hyperaesthesia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    2
    1
    Syncope
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye swelling
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid exfoliation
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Nausea
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blister
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Dermatitis atopic
         subjects affected / exposed
    5 / 49 (10.20%)
    4 / 52 (7.69%)
    2 / 51 (3.92%)
    4 / 50 (8.00%)
         occurrences all number
    5
    4
    2
    4
    Dermatitis contact
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    4 / 50 (8.00%)
         occurrences all number
    9
    0
    1
    5
    Eczema
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eczema weeping
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    2
    Erythema
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 52 (5.77%)
    8 / 51 (15.69%)
    6 / 50 (12.00%)
         occurrences all number
    12
    3
    12
    8
    Pain of skin
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Papule
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    1
    Pruritus
         subjects affected / exposed
    7 / 49 (14.29%)
    8 / 52 (15.38%)
    10 / 51 (19.61%)
    7 / 50 (14.00%)
         occurrences all number
    17
    12
    19
    10
    Rash
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Scab
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Skin burning sensation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 52 (5.77%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Skin fissures
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    5
    1
    1
    0
    Skin irritation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin tightness
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sunburn
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Urogenital disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Bursitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    2
    Herpes virus infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    1
    2
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 52 (3.85%)
    0 / 51 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    2
    0
    6
    Pharyngitis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    1
    1
    Vaginal infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vaginitis bacterial
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2013
    • Personnel and CRO name changes. • Guidelines around pregnancy and contraception updated. • Clarification of washout period. • Two medications excluded from the restricted concomitant medication list. • Reporting of adverse events. Change of responsible Party.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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