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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 Acne Vulgaris

    Summary
    EudraCT number
    		 2012-004965-41
    Trial protocol
    		 DE   HU   SK  
    Global end of trial date
    10 Feb 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Sep 2022
    First version publication date
    25 May 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DS107E-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dignity Sciences Limited
    Sponsor organisation address
    Trintech Building, South County Business Park, Dublin 18, Ireland, Dublin 18
    Public contact
    David Coughlan, Dignity Sciences Limited, +353 12933590, david.coughlan@dignitysciences.com
    Scientific contact
    David Coughlan, Dignity Sciences Limited, +353 12933590, david.coughlan@dignitysciences.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
    27 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this proof-of-concept study was to compare the efficacy of different concentrations of the study treatment (DS107E,dihomo-gamma-linolenic acid [DGLA]cream) on facial papulopustular acne in comparison to a placebo control. The secondary objective of this study was to assess the safety and tolerability of topically applied DS107E DGLA cream in different concentrations.
    Protection of trial subjects
    The study was managed and conducted according to 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
    10 Jun 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
    Slovakia: 56
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Hungary: 64
    Worldwide total number of subjects
    154
    EEA total number of subjects
    154
    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)
    32
    Adults (18-64 years)
    122
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study was carried out in 3 countries (Germany, Slovakia, and Hungary) across 16 investigational sites.

    Pre-assignment
    Screening details
    		 The study consisted of a wash out period of maximum 14 days; a 12-week treatment period and a 4 week 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 Placebo cream
    Arm description
    		 DS107E Placebo Cream applied topically to all affected areas twice-daily for 12 weeks. The DS107E Placebo Cream was identical in composition to formulation of DS107E DGLA cream minus active drug substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo matching DS107E DGLA 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 areas twice-daily for 12 weeks.

    Arm title
    		 DS107E DGLA 1% cream
    Arm description
    		 DS107E DGLA 1% Cream applied topically to all affected areas twice-daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DS107E DGLA 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 areas twice-daily for 12 weeks.

    Arm title
    		 DS107E DGLA 5% cream
    Arm description
    		 DS107E DGLA 5% Cream applied topically to all affected areas twice-daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    DS107E DGLA 5% 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 areas twice-daily for 12 weeks.

    Number of subjects in period 1
    		DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Started
    49
    53
    52
    Completed
    46
    49
    44
    Not completed
    3
    4
    8
         Adverse event, non-fatal
    1
    -
    -
         Other
    -
    1
    1
         Subject request
    -
    1
    4
         Lost to follow-up
    -
    2
    -
         Lack of efficacy
    2
    -
    1
         Protocol deviation
    -
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    DS107E Placebo cream
    Reporting group description
    		 DS107E Placebo Cream applied topically to all affected areas twice-daily for 12 weeks. The DS107E Placebo Cream was identical in composition to formulation of DS107E DGLA cream minus active drug substance.

    Reporting group title
    DS107E DGLA 1% cream
    Reporting group description
    		 DS107E DGLA 1% Cream applied topically to all affected areas twice-daily for 12 weeks.

    Reporting group title
    DS107E DGLA 5% cream
    Reporting group description
    		 DS107E DGLA 5% Cream applied topically to all affected areas twice-daily for 12 weeks

    Reporting group values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream Total
    Number of subjects
    		 49 53 52 154
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 14 7 11 32
        Adults (18-64 years)
    		 35 46 41 122
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.7 ( 6.33 ) 23.1 ( 6.06 ) 22.8 ( 5.78 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 45 34 114
        Male
    		 14 8 18 40
    Race
    Units: Subjects
        White
    		 48 52 50 150
        Black
    		 0 1 0 1
        Asian
    		 0 0 0 0
        American Indian or Alaska Native
    		 0 0 0 0
        Native Hawaiian or other Pacific Islander
    		 0 0 0 0
        Other
    		 0 0 1 1
        Mixed
    		 1 0 1 2
        Missing
    		 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    DS107E Placebo cream
    Reporting group description
    		 DS107E Placebo Cream applied topically to all affected areas twice-daily for 12 weeks. The DS107E Placebo Cream was identical in composition to formulation of DS107E DGLA cream minus active drug substance.

    Reporting group title
    DS107E DGLA 1% cream
    Reporting group description
    		 DS107E DGLA 1% Cream applied topically to all affected areas twice-daily for 12 weeks.

    Reporting group title
    DS107E DGLA 5% cream
    Reporting group description
    		 DS107E DGLA 5% Cream applied topically to all affected areas twice-daily for 12 weeks

    Primary: Change in Investigators Global Assessment (IGA) of acne severity from baseline to the end of week 12.

    		 Close Top of page
    End point title
    		 Change in Investigators Global Assessment (IGA) of acne severity from baseline to the end of week 12.
    End point description
    Mean Change from Baseline of IGA Score to Week 12.
    End point type
    Primary
    End point timeframe
    Up to 12 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    46
    50
    44
    Units: IGA scores
        arithmetic mean (standard deviation)
    -0.4 ( 0.75 )
    -0.3 ( 0.64 )
    -0.3 ( 0.56 )
    Statistical analysis title
    		 DS107E DGLA 1% Cream V Placebo
    Comparison groups
    DS107E Placebo cream v DS107E DGLA 1% cream
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 ANCOVA
    Parameter type
    		 Mean Change in IGA Score
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.3
    Statistical analysis title
    		 DS107E DGLA 5% Cream V Placebo
    Comparison groups
    DS107E Placebo cream v DS107E DGLA 5% cream
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.909
    Method
    		 ANCOVA
    Parameter type
    		 Mean Change in IGA Score
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.4

    Primary: Change of total count of acne lesions from baseline to the end of week 12

    		 Close Top of page
    End point title
    		 Change of total count of acne lesions from baseline to the end of week 12
    End point description
    Mean Change from Baseline of Total Lesion Count to Week 12.
    End point type
    Primary
    End point timeframe
    Up to 12 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    46
    50
    44
    Units: Total lesion count
        arithmetic mean (standard deviation)
    -32.5 ( 29.42 )
    -30.5 ( 32.03 )
    -27.1 ( 25.68 )
    Statistical analysis title
    		 DS107E DGLA 1% Cream V Placebo
    Comparison groups
    DS107E Placebo cream v DS107E DGLA 1% cream
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.651
    Method
    		 ANCOVA
    Parameter type
    		 Mean Change in Total Lesion Count
    Point estimate
    2.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 11.2
    Statistical analysis title
    		 DS107E DGLA 5% Cream V Placebo
    Comparison groups
    DS107E Placebo cream v DS107E DGLA 5% cream
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.876
    Method
    		 ANCOVA
    Parameter type
    		 Mean Change in Total Lesion Count
    Point estimate
    6.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 15.9

    Secondary: Change in Investigators Global Assessment (IGA) of acne severity after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment).

    		 Close Top of page
    End point title
    		 Change in Investigators Global Assessment (IGA) of acne severity after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment).
    End point description
    Change in Investigators Global Assessment (IGA) of acne severity after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment).
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: IGA Scores
    arithmetic mean (standard deviation)
        Week 2
    -0.1 ( 0.47 )
    -0.1 ( 0.43 )
    -0.1 ( 0.38 )
        Week 4
    -0.1 ( 0.47 )
    -0.1 ( 0.39 )
    -0.2 ( 0.43 )
        Week 8
    -0.4 ( 0.69 )
    -0.3 ( 0.55 )
    -0.3 ( 0.52 )
        Week 12
    -0.4 ( 0.75 )
    -0.3 ( 0.64 )
    -0.3 ( 0.56 )
        Week 16
    -0.3 ( 0.84 )
    -0.4 ( 0.79 )
    -0.4 ( 0.66 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Total Lesion Count).

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Total Lesion Count).
    End point description
    Mean Change from Baseline of Total Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total lesion count
    arithmetic mean (standard deviation)
        Change from Baseline to Week 2
    -12.4 ( 16.27 )
    -14.8 ( 17.32 )
    -10.6 ( 19.09 )
        Observed value Week 2
    67.4 ( 46.41 )
    59.6 ( 34.06 )
    68.8 ( 37.95 )
        Change from Baseline to Week 4
    -22.4 ( 19.08 )
    -23.0 ( 19.58 )
    -17.0 ( 21.80 )
        Observed value Week 4
    52.6 ( 30.01 )
    51.4 ( 34.42 )
    60.8 ( 36.55 )
        Change from Baseline to Week 8
    -30.7 ( 28.81 )
    -26.5 ( 29.07 )
    -20.5 ( 42.98 )
        Observed value Week 8
    43.2 ( 29.97 )
    47.5 ( 40.8 )
    56.3 ( 42.98 )
        Change from Baseline to Week 12
    -32.5 ( 29.42 )
    -30.5 ( 32.03 )
    -27.1 ( 25.68 )
        Observed value Week 12
    41.5 ( 34.27 )
    43.8 ( 39.01 )
    50.4 ( 34.29 )
        Change from Baseline to Week 16
    -28.5 ( 30.99 )
    -34.3 ( 40.55 )
    -24.8 ( 35.53 )
        Observed value Week 16
    51.3 ( 48.17 )
    40.8 ( 32.00 )
    54.6 ( 41.63 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory Lesion Count).

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory Lesion Count).
    End point description
    Mean change from baseline of Inflammatory Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total count
    arithmetic mean (standard deviation)
        Week 2
    -6.3 ( 8.38 )
    -7.0 ( 12.85 )
    -5.4 ( 10.00 )
        Week 4
    -12.4 ( 10.62 )
    -12.0 ( 12.04 )
    -10.4 ( 12.75 )
        Week 8
    -14.4 ( 12.44 )
    -13.6 ( 12.14 )
    -12.8 ( 14.46 )
        Week 12
    -15.5 ( 12.67 )
    -15.1 ( 13.48 )
    -14.6 ( 12.92 )
        Week 16
    -13.8 ( 13.56 )
    -15.9 ( 15.31 )
    -12.4 ( 19.06 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Non-inflammatory Lesion Count).

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Non-inflammatory Lesion Count).
    End point description
    Mean change from baseline of Non-inflammatory Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total count
    arithmetic mean (standard deviation)
        Week 2
    -6.1 ( 11.45 )
    -7.8 ( 16.45 )
    -5.1 ( 16.55 )
        Week 4
    -9.9 ( 11.73 )
    -10.9 ( 21.13 )
    -6.5 ( 18.34 )
        Week 8
    -16.2 ( 20.46 )
    -12.9 ( 26.40 )
    -7.6 ( 20.83 )
        Week 12
    -17.0 ( 22.72 )
    -15.4 ( 30.84 )
    -12.4 ( 19.16 )
        Week 16
    -14.9 ( 23.45 )
    -18.4 ( 38.74 )
    -12.4 ( 23.13 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory and Non-inflammatory)

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory and Non-inflammatory)
    End point description
    Mean change from baseline of Inflammatory and Non-inflammatory Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total count
    arithmetic mean (standard deviation)
        Week 2
    -12.4 ( 16.18 )
    -14.8 ( 17.34 )
    -10.5 ( 19.16 )
        Week 4
    -22.3 ( 19.17 )
    -22.9 ( 19.55 )
    -16.9 ( 21.85 )
        Week 8
    -30.6 ( 28.71 )
    -26.5 ( 28.98 )
    -20.4 ( 28.25 )
        Week 12
    -32.5 ( 29.22 )
    -30.5 ( 31.84 )
    -27.0 ( 25.61 )
        Week 16
    -28.8 ( 30.63 )
    -34.3 ( 40.47 )
    -24.7 ( 35.33 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Total lesion count).

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Total lesion count).
    End point description
    Mean Percent Change from Baseline of Total Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total lesion count
    arithmetic mean (standard deviation)
        Week 2
    -16.9 ( 19.53 )
    -19.0 ( 21.19 )
    -14.1 ( 21.82 )
        Week 4
    -29.3 ( 24.52 )
    -31.8 ( 22.87 )
    -21.4 ( 25.72 )
        Week 8
    -41.4 ( 28.84 )
    -37.2 ( 33.55 )
    -26.4 ( 36.94 )
        Week 12
    -45.8 ( 27.37 )
    -40.0 ( 45.74 )
    -33.3 ( 36.02 )
        Week 16
    -37.3 ( 30.30 )
    -37.9 ( 63.23 )
    -30.0 ( 39.28 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory lesion count).

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory lesion count).
    End point description
    Mean Percent Change from Baseline of Inflammatory Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total count
    arithmetic mean (standard deviation)
        Week 2
    -23.2 ( 32.41 )
    -12.3 ( 73.59 )
    -18.3 ( 27.01 )
        Week 4
    -41.7 ( 30.56 )
    -33.9 ( 54.63 )
    -32.3 ( 34.59 )
        Week 8
    -50.1 ( 36.89 )
    -43.6 ( 40.37 )
    -42.4 ( 38.84 )
        Week 12
    -53.3 ( 37.14 )
    -46.5 ( 73.84 )
    -47.6 ( 32.10 )
        Week 16
    -48.5 ( 39.47 )
    -52.4 ( 47.30 )
    -40.6 ( 42.96 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Non-inflammatory lesion count).

    		 Close Top of page
    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Non-inflammatory lesion count).
    End point description
    Mean Percent Change from Baseline of Non-inflammatory Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total count
    arithmetic mean (standard deviation)
        Week 2
    -4.4 ( 64.80 )
    -4.2 ( 82.82 )
    -1.7 ( 61.51 )
        Week 4
    -19.6 ( 36.05 )
    -13.3 ( 81.70 )
    36.9 ( 365.18 )
        Week 8
    -33.9 ( 33.64 )
    -14.9 ( 93.07 )
    27.2 ( 280.62 )
        Week 12
    -40.9 ( 32.07 )
    -11.7 ( 113.97 )
    10.9 ( 236.25 )
        Week 16
    -23.6 ( 54.52 )
    0.2 ( 157.74 )
    11.8 ( 225.53 )
    No statistical analyses for this end point

    Secondary: Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory and Non-inflammatory).

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    End point title
    		 Count of acne lesions in the face after 2, 4, 8 and 12 weeks of treatment and at follow-up (4 weeks after the end of treatment) and its percentage and absolute change to baseline for the three parameters separately (Inflammatory and Non-inflammatory).
    End point description
    Mean Percent Change from Baseline of Inflammatory and Non-inflammatory Lesion Count by Visit.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks.
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Total count
    arithmetic mean (standard deviation)
        Week 2
    -17.1 ( 19.76 )
    -19.1 ( 21.26 )
    -14.1 ( 21.92 )
        Week 4
    -29.2 ( 24.70 )
    -31.8 ( 22.86 )
    -21.4 ( 25.73 )
        Week 8
    -41.4 ( 29.00 )
    -37.2 ( 33.43 )
    -26.4 ( 36.93 )
        Week 12
    -45.9 ( 27.17 )
    -40.00 ( 45.60 )
    -33.3 ( 36.01 )
        Week 16
    -37.7 ( 30.07 )
    -38.0 ( 63.14 )
    -30.0 ( 39.17 )
    No statistical analyses for this end point

    Secondary: Time to Reduction of acne lesions by >30%

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    End point title
    		 Time to Reduction of acne lesions by >30%
    End point description
    Analysis of Time to Reduction of Total Lesion Count by >30% from Baseline.
    End point type
    Secondary
    End point timeframe
    Up to 16 weeks
    End point values
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Number of subjects analysed
    49
    53
    51
    Units: Events observed
        Event observed
    40
    42
    34
        Censored
    9
    11
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 16 weeks.
    Adverse event reporting additional description
    Any undesirable experience occurring to a patient that has signed the ICF, whether or not considered related to the investigational treatment. All Adverse Events must be recorded in the case report form, defining relationship to treatment and severity.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    DS107E Placebo cream
    Reporting group description
    		 DS107E Placebo Cream applied topically to all affected areas twice-daily for 12 weeks. The DS107E Placebo Cream was identical in composition to formulation of DS107E DGLA cream minus active drug substance.

    Reporting group title
    DS107E DGLA 1% cream
    Reporting group description
    		 DS107E DGLA 1% Cream applied topically to all affected areas twice-daily for 12 weeks.

    Reporting group title
    DS107E DGLA 5% cream
    Reporting group description
    		 DS107E DGLA 5% Cream applied topically to all affected areas twice-daily for 12 weeks

    Serious adverse events
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DS107E Placebo cream DS107E DGLA 1% cream DS107E DGLA 5% cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 49 (42.86%)
    18 / 53 (33.96%)
    21 / 52 (40.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    1
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    2 / 52 (3.85%)
         occurrences all number
    0
    1
    2
    Pyrexia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    1
    0
    1
    Oedema
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    3
    1
    0
    Menstrual discomfort
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    2
    0
    Premenstrual pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Premenstrual syndrome
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    1
    Nasal congestion
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Lymph node palpable
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    1
    Hand fracture
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 53 (1.89%)
    4 / 52 (7.69%)
         occurrences all number
    6
    2
    9
    Migraine
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    0
    4
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    3 / 52 (5.77%)
         occurrences all number
    0
    1
    3
    Diarrhoea
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    0
    6
    Abdominal pain upper
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    1
    Alopecia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Angiokeratoma
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    1
    Arthralgia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Muscle tightness
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 49 (8.16%)
    3 / 53 (5.66%)
    2 / 52 (3.85%)
         occurrences all number
    4
    4
    2
    Influenza
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 53 (3.77%)
    2 / 52 (3.85%)
         occurrences all number
    0
    2
    2
    Pharyngitis
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 53 (3.77%)
    1 / 52 (1.92%)
         occurrences all number
    1
    2
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    2 / 52 (3.85%)
         occurrences all number
    0
    0
    2
    Viral infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    1
    0
    1
    Abscess
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Acute sinusitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Appendicitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 53 (1.89%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    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
    22 May 2013
    CRO name removed update to inclusion and exclusion criteria. Washout phase clarification Application of IMP clarification Baseline visit window clarification Concomitant medication clarification

    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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    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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