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    Clinical Trial Results:
    A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide) Once Daily Gel Compared with Clindamycin Phosphate gel (1% clindamycin as clindamycin phosphate) twice daily in the Treatment of Mild to Moderate Acne Vulgaris.

    Summary
    EudraCT number
    		 2015-004909-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2016
    First version publication date
    29 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    114543
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    27 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 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
    China: 1016
    Worldwide total number of subjects
    1016
    EEA total number of subjects
    0
    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)
    56
    Adults (18-64 years)
    960
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1020 participants were randomized and enrolled in this study. Four participants were excluded following randomization because they did not receive at least one application of the study product. Overall, 1016 participants were included in the ITT population and 903 participants were included in the PP population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The protocol was conducted using an assessor-blinded design. This was an assessor-blinded study; therefore, assessors who assessed the lesion count, ISGA and local tolerability, and programmers and the statisticians were blinded, while the other individuals involved in the conduct of clinical study were not blinded to investigational product allocations. The assessor was unaware of which investigational product was being used.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duac Once Daily Gel
    Arm description
    		 Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duac gel (1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Duac gel (once daily in the evening) for 12 weeks

    Arm title
    		 Dalin Gel
    Arm description
    		 Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dalin gel (1% clindamycin as clindamycin phosphate)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Dalin gel twice daily in the morning and evening by the participants for 12 weeks

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This study was conducted using an assessor-blinded design.
    Number of subjects in period 1
    		Duac Once Daily Gel Dalin Gel
    Started
    500
    516
    Completed
    430
    445
    Not completed
    70
    71
         Got Well
    -
    1
         Par. not Willing to Continue Treatment
    -
    1
         Job Transfer
    -
    1
         Recovered
    1
    -
         Consent withdrawn by subject
    18
    18
         Drug Release Error
    1
    -
         Adverse event, non-fatal
    12
    4
         Failure to Meet Randomization Criteria
    1
    -
         Par. Unable to Come to the Hospital
    -
    1
         Pregnancy
    1
    -
         Improper Facial Procedure
    -
    1
         Par. Improved, Voluntary (Vol) exit
    1
    -
         Par. Conscious Ineffective Vol Exit
    1
    -
         Poor Perceived Efficacy
    1
    -
         Lost to follow-up
    22
    26
         Par. Refused to Hospital Visits
    -
    1
         Lack of efficacy
    6
    11
         Protocol deviation
    5
    5
         Poor Conscious Effect
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Duac Once Daily Gel
    Reporting group description
    		 Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.

    Reporting group title
    Dalin Gel
    Reporting group description
    		 Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

    Reporting group values
    		 Duac Once Daily Gel Dalin Gel Total
    Number of subjects
    		 500 516
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 23.4 ( 4.64 ) 23.3 ( 4.29 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 382 383 765
        Male
    		 118 133 251
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 500 515 1015
        White
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Duac Once Daily Gel
    Reporting group description
    		 Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.

    Reporting group title
    Dalin Gel
    Reporting group description
    		 Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

    Primary: Absolute change in total lesion count from Baseline to Week 12

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    End point title
    		 Absolute change in total lesion count from Baseline to Week 12
    End point description
    The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data. Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    484 [1]
    499 [2]
    Units: Change in lesion count
        least squares mean (standard error)
    -55.7 ( 1.05 )
    -51.2 ( 1.03 )
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    983
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 -1.6

    Primary: Absolute change in total lesion count from Baseline to Week 12

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    End point title
    		 Absolute change in total lesion count from Baseline to Week 12
    End point description
    The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data. Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    433 [3]
    449 [4]
    Units: Change in lesion count
        least squares mean (standard error)
    -56.7 ( 0.97 )
    -52.1 ( 0.96 )
    Notes
    [3] - PP Population
    [4] - PP Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    882
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 -1.9

    Primary: Number of participants with an improvement of 2 grades in the Investigator Static Global Assessment (ISGA) score from Baseline to Week 12

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    End point title
    		 Number of participants with an improvement of 2 grades in the Investigator Static Global Assessment (ISGA) score from Baseline to Week 12
    End point description
    ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    500 [5]
    516 [6]
    Units: Participants
    151
    117
    Notes
    [5] - ITT Population
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    1016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.018
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Primary: Number of participants with an improvement of 2 grades in the Investigator Static Global Assessment (ISGA) score from Baseline to Week 12

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    End point title
    		 Number of participants with an improvement of 2 grades in the Investigator Static Global Assessment (ISGA) score from Baseline to Week 12
    End point description
    ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    442 [7]
    461 [8]
    Units: Participants
    142
    110
    Notes
    [7] - PP Population
    [8] - PP Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    903
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.013
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Absolute change in inflammatory lesion counts and non-inflammatory lesion counts from Baseline to Week 12

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    End point title
    		 Absolute change in inflammatory lesion counts and non-inflammatory lesion counts from Baseline to Week 12
    End point description
    The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    484 [9]
    499 [10]
    Units: Lesions
    least squares mean (standard error)
        IL
    -20.6 ( 0.36 )
    -19.7 ( 0.35 )
        NIL
    -35 ( 0.83 )
    -31.6 ( 0.82 )
    Notes
    [9] - ITT Population
    [10] - ITT Population
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    983
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 -1.1
    Notes
    [11] - Statistical data for the category=NIL
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Statistical data for the category=IL
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    983
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.077
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.1

    Secondary: Absolute change in inflammatory lesion counts and non-inflammatory lesion counts from Baseline to Week 12

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    End point title
    		 Absolute change in inflammatory lesion counts and non-inflammatory lesion counts from Baseline to Week 12
    End point description
    The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    433 [12]
    449 [13]
    Units: Lesions
    least squares mean (standard error)
        IL
    -20.9 ( 0.34 )
    -19.9 ( 0.34 )
        NIL
    -35.7 ( 0.78 )
    -32.3 ( 0.77 )
    Notes
    [12] - PP Population
    [13] - PP Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Statistical data for the category=IL
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    882
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.028
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.1
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Statistical data for the category=NIL
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    882
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 -1.2

    Secondary: Percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 12

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    End point title
    		 Percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 12
    End point description
    The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    484 [14]
    499 [15]
    Units: Percent change in lesions
    least squares mean (standard error)
        IL
    -0.78 ( 0.013 )
    -0.75 ( 0.013 )
        NIL
    -0.67 ( 0.018 )
    -0.6 ( 0.018 )
        Total
    -0.72 ( 0.013 )
    -0.67 ( 0.013 )
    Notes
    [14] - ITT Population
    [15] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Statistical data for the category=IL
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    983
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.08
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Statistical data for the category=NIL
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    983
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 -0.02
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Statisticial data for the category=Total
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    983
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 -0.02

    Secondary: Percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 12

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    End point title
    		 Percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 12
    End point description
    The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    433 [16]
    449 [17]
    Units: Percent change in lesions
    least squares mean (standard error)
        IL
    -0.8 ( 0.012 )
    -0.76 ( 0.012 )
        NIL
    -0.7 ( 0.018 )
    -0.61 ( 0.017 )
        Total
    -0.74 ( 0.012 )
    -0.68 ( 0.012 )
    Notes
    [16] - PP Population
    [17] - PP Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Statistical data for the category=IL
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    882
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Statistical data for the category=Total
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    882
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 -0.03
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Statistical data for the category=NIL
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    882
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 -0.04

    Secondary: Number of participants who had an ISGA score of 0 or 1 at Week 12

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    End point title
    		 Number of participants who had an ISGA score of 0 or 1 at Week 12
    End point description
    The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    500 [18]
    516 [19]
    Units: Participants
    209
    151
    Notes
    [18] - ITT Population
    [19] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Dalin Gel v Duac Once Daily Gel
    Number of subjects included in analysis
    1016
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of participants who had an ISGA score of 0 or 1 at Week 12

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    End point title
    		 Number of participants who had an ISGA score of 0 or 1 at Week 12
    End point description
    The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Duac Once Daily Gel Dalin Gel
    Number of subjects analysed
    442 [20]
    461 [21]
    Units: Participants
    196
    144
    Notes
    [20] - PP Population
    [21] - PP Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Duac Once Daily Gel v Dalin Gel
    Number of subjects included in analysis
    903
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until the end of study treatment (up to Week 12).
    Adverse event reporting additional description
    SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Duac Once Daily Gel
    Reporting group description
    		 Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.

    Reporting group title
    Dalin Gel
    Reporting group description
    		 Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

    Serious adverse events
    		 Duac Once Daily Gel Dalin Gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 500 (0.20%)
    0 / 516 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Thermal burn
    Additional description: SAEs and non-serious AEs are reported for the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of study medication.
         subjects affected / exposed
    1 / 500 (0.20%)
    0 / 516 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Duac Once Daily Gel Dalin Gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 500 (5.20%)
    4 / 516 (0.78%)
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    26 / 500 (5.20%)
    4 / 516 (0.78%)
         occurrences all number
    35
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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