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    Clinical Trial Results:
    A Multi-Center Randomized Double Blind Verhicle-Controlled, Phase 2 Study of the safety and efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream when used in combination in the treatment of Acne Vulgaris

    Summary
    EudraCT number
    		 2015-004900-44
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Mar 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Mar 2017
    First version publication date
    22 Jan 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    114570
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of Duac and Tazorac when applied simultaneously to subjects with facial acne vulgaris.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 587
    Worldwide total number of subjects
    587
    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)
    301
    Adults (18-64 years)
    286
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 In this multi-center, double-blind, vehicle controlled study, participants were assigned to one of the six treatment groups in a 2:2:2:2:2:1 ratio for 12 weeks.

    Pre-assignment
    Screening details
    		 Participants with facial acne vulgaris, 12 to 45 years of age were enrolled in this study. A total of 596 participants were randomized and 587 participants received study product.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benzoyl peroxide/Clindamycin + Tazarotene
    Arm description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benzoyl peroxide/Clindamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Benzoyl peroxide/Clindamycin contained 1% clindamycin phosphate and 5% BPO in a gel vehicle. It was applied once daily in the evening.

    Investigational medicinal product name
    Tazarotene
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Tazarotene, which contained 0.1 % tazarotene in a cream vehicle. It was applied once daily in the evening.

    Arm title
    		 Benzoyl peroxide/Clindamycin + vehicle cream
    Arm description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Benzoyl peroxide/Clindamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Benzoyl peroxide/Clindamycin contained 1% clindamycin phosphate and 5% BPO in a gel vehicle. It was applied once daily in the evening.

    Investigational medicinal product name
    Vehicle cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Vehicle cream contained identical ingredients as Tazarotene but without the active ingredient. It was applied once daily in the evening.

    Arm title
    		 Benzoyl peroxide gel + Tazarotene
    Arm description
    		 Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Benzoyl Peroxide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Benzoyl Peroxide gel contained identical ingredients as Benzoyl peroxide/Clindamycin but without the clindamycin. It was applied once daily in the evening.

    Investigational medicinal product name
    Tazarotene
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Tazarotene, which contained 0.1 % tazarotene in a cream vehicle. It was applied once daily in the evening.

    Arm title
    		 Clindamycin gel + Tazarotene
    Arm description
    		 Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clindamycin gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Clindamycin gel contained identical ingredients as Benzoyl peroxide/Clindamycin but without the Benzoyl Peroxide. It was applied once daily in the evening.

    Investigational medicinal product name
    Tazarotene
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Tazarotene, which contained 0.1 % tazarotene in a cream vehicle. It was applied once daily in the evening.

    Arm title
    		 Vehicle gel + Tazarotene
    Arm description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vehicle gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Vehicle gel contained identical ingredients as Benzoyl peroxide/Clindamycin but without the active ingredients. It was applied once daily in the evening.

    Investigational medicinal product name
    Tazarotene
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Tazarotene, which contained 0.1 % tazarotene in a cream vehicle. It was applied once daily in the evening.

    Arm title
    		 Vehicle gel + vehicle cream
    Arm description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Vehicle gel contained identical ingredients as Benzoyl peroxide/Clindamycin but without the active ingredients. It was applied once daily in the evening.

    Investigational medicinal product name
    Vehicle cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Vehicle cream contained identical ingredients as Tazarotene but without the active ingredient. It was applied once daily in the evening.

    Number of subjects in period 1
    		Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Started
    106
    105
    107
    108
    106
    55
    Completed
    85
    90
    92
    99
    87
    47
    Not completed
    21
    15
    15
    9
    19
    8
         Consent withdrawn by subject
    6
    1
    5
    1
    5
    7
         Adverse event, non-fatal
    2
    -
    2
    2
    3
    1
         Non-compliance with Study Treatment
    1
    1
    2
    -
    1
    -
         Lost to follow-up
    5
    7
    5
    5
    7
    -
         Lack of efficacy
    1
    3
    -
    -
    1
    -
         Protocol deviation
    6
    3
    1
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benzoyl peroxide/Clindamycin + Tazarotene
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Benzoyl peroxide/Clindamycin + vehicle cream
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Benzoyl peroxide gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Clindamycin gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Vehicle gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Vehicle gel + vehicle cream
    Reporting group description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group values
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream Total
    Number of subjects
    		 106 105 107 108 106 55
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 19.7 ( 6.2 ) 19.7 ( 6.9 ) 20.2 ( 7.3 ) 19.2 ( 6.2 ) 21.7 ( 8.4 ) 19.8 ( 6.6 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 58 56 60 60 65 35 334
        Male
    		 48 49 47 48 41 20 253
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 0 0 1
        Asian
    		 8 14 5 6 9 5 47
        Black
    		 23 16 24 15 14 8 100
        Multiracial
    		 10 11 9 8 8 5 51
        Native Hawaiian or Other Pacific Islander
    		 1 1 1 0 1 0 4
        White
    		 63 63 68 79 74 37 384

    End points

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    End points reporting groups
    Reporting group title
    Benzoyl peroxide/Clindamycin + Tazarotene
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Benzoyl peroxide/Clindamycin + vehicle cream
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Benzoyl peroxide gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Clindamycin gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Vehicle gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Vehicle gel + vehicle cream
    Reporting group description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Subject analysis set title
    Benzoyl peroxide/Clindamycin + Tazarotene
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Subject analysis set title
    Benzoyl peroxide/Clindamycin + vehicle cream
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Subject analysis set title
    Benzoyl peroxide gel + Tazarotene.
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Subject analysis set title
    Clindamycin gel + Tazarotene.
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Subject analysis set title
    Vehicle gel + Tazarotene.
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Subject analysis set title
    Vehicle gel + vehicle cream.
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Primary: Absolute change in lesion counts (total, inflammatory, and non-inflammatory) from Baseline to Week 12

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    End point title
    		 Absolute change in lesion counts (total, inflammatory, and non-inflammatory) from Baseline to Week 12
    End point description
    The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline and up to Week 12
    End point values
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Number of subjects analysed
    106 [1]
    105 [2]
    107 [3]
    107 [4]
    106 [5]
    55 [6]
    Units: Lesion count
    arithmetic mean (standard deviation)
        ILC, n=101, 103, 105, 105, 104, 52
    -16.8 ( 14.35 )
    -18.1 ( 14.45 )
    -18.9 ( 12.84 )
    -18.8 ( 11.49 )
    -14.5 ( 12.76 )
    -8.96 ( 12.63 )
        NILC, n=101, 103, 105, 105, 104, 52
    -33 ( 23.94 )
    -24.9 ( 33.41 )
    -37.1 ( 29.7 )
    -37.5 ( 29.51 )
    -33 ( 25.89 )
    -18.9 ( 28.41 )
        TLC, n=101, 103, 105, 105, 104, 52
    -49.8 ( 31.78 )
    -43 ( 42.24 )
    -56 ( 34.99 )
    -56.3 ( 35.42 )
    -47.6 ( 33.32 )
    -27.8 ( 35.06 )
    Notes
    [1] - Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reach
    [2] - Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reach
    [3] - Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reach
    [4] - Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reach
    [5] - Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reach
    [6] - Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reach
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.692 [7]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [7] - For ILC
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.467 [8]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [8] - For ILC
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281 [9]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [9] - For ILC
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.075 [10]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [10] - For ILC
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [11]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [11] - For ILC
    Statistical analysis title
    		 Statistical analysis 6
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [12]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [12] - For NILC
    Statistical analysis title
    		 Statistical analysis 7
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.803 [13]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [13] - For NILC
    Statistical analysis title
    		 Statistical analysis 8
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.175 [14]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [14] - For NILC
    Statistical analysis title
    		 Statistical analysis 9
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.552 [15]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [15] - For NILC
    Statistical analysis title
    		 Statistical analysis 10
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [16]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [16] - For NILC
    Statistical analysis title
    		 Statistical analysis 11
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [17]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [17] - For TC
    Statistical analysis title
    		 Statistical analysis 12
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.618 [18]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [18] - For TC
    Statistical analysis title
    		 Statistical analysis 13
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.149 [19]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [19] - For TC
    Statistical analysis title
    		 Statistical analysis 14
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.255 [20]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [20] - For TC
    Statistical analysis title
    		 Statistical analysis 15
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [21]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [21] - For TC

    Primary: Proportion of participants with a minimum 2-grade improvement in the Investigator’s Static Global Assessment (ISGA) score from Baseline to Week 12

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    End point title
    		 Proportion of participants with a minimum 2-grade improvement in the Investigator’s Static Global Assessment (ISGA) score from Baseline to Week 12
    End point description
    An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline and up to Week 12
    End point values
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Number of subjects analysed
    106 [22]
    105 [23]
    107 [24]
    108 [25]
    106 [26]
    55 [27]
    Units: Percentage of participants
    22
    22
    31
    36
    20
    5
    Notes
    [22] - ITT Analysis Set
    [23] - ITT Analysis Set
    [24] - ITT Analysis Set
    [25] - ITT Analysis Set
    [26] - ITT Analysis Set
    [27] - ITT Analysis Set
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.922
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.132
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.706
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percent change from Baseline to Week 12 in each of 3 lesion counts (total, inflammatory, and non-inflammatory)

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    End point title
    		 Percent change from Baseline to Week 12 in each of 3 lesion counts (total, inflammatory, and non-inflammatory)
    End point description
    The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to Week 12
    End point values
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Number of subjects analysed
    106 [28]
    105 [29]
    107 [30]
    108 [31]
    106 [32]
    55 [33]
    Units: Percent change
    arithmetic mean (standard deviation)
        ILC, n=101, 103, 105, 105, 104, 52
    -58.3 ( 45.57 )
    -62.4 ( 39.33 )
    -62.4 ( 34.83 )
    -65.7 ( 33.38 )
    -49 ( 40.9 )
    -33.5 ( 41.1 )
        NILC, n=101, 103, 105, 105, 104, 52
    -58 ( 29.97 )
    -39.2 ( 51.29 )
    -60.6 ( 35 )
    -61.2 ( 31.6 )
    -53.1 ( 30.56 )
    -29.5 ( 44.05 )
        TLC, n=101, 103, 105, 105, 104, 52
    -59.1 ( 29.96 )
    -47.9 ( 38.89 )
    -62 ( 29.42 )
    -63.4 ( 28.75 )
    -51.8 ( 29.18 )
    -31.5 ( 37.59 )
    Notes
    [28] - ITT Analysis Set
    [29] - ITT Analysis Set
    [30] - ITT Analysis Set
    [31] - ITT Analysis Set
    [32] - ITT Analysis Set
    [33] - ITT Analysis Set
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.504 [34]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [34] - For ILC
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.504 [35]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [35] - For ILC
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177 [36]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [36] - For ILC
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084 [37]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [37] - For ILC
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [38]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [38] - For ILC
    Statistical analysis title
    		 Statistical analysis 6
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [39]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [39] - For NILC
    Statistical analysis title
    		 Statistical analysis 7
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.776 [40]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [40] - For NILC
    Statistical analysis title
    		 Statistical analysis 8
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.465 [41]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [41] - For NILC
    Statistical analysis title
    		 Statistical analysis 9
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.288 [42]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [42] - For NILC
    Statistical analysis title
    		 Statistical analysis 10
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [43]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [43] - For NILC
    Statistical analysis title
    		 Statistical analysis 11
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [44]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [44] - For TC
    Statistical analysis title
    		 Statistical analysis 12
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62 [45]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [45] - For TC
    Statistical analysis title
    		 Statistical analysis 13
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291 [46]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [46] - For TC
    Statistical analysis title
    		 Statistical analysis 14
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.085 [47]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [47] - For TC
    Statistical analysis title
    		 Statistical analysis 15
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [48]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [48] - For TC

    Secondary: Proportion of Participants with an ISGA score of 0 or 1 at Week 12

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    End point title
    		 Proportion of Participants with an ISGA score of 0 or 1 at Week 12
    End point description
    An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Number of subjects analysed
    106 [49]
    105 [50]
    107 [51]
    108 [52]
    106 [53]
    55 [54]
    Units: Percentage of participants
    33
    31
    27
    39
    22
    13
    Notes
    [49] - ITT Analysis Set
    [50] - ITT Analysis Set
    [51] - ITT Analysis Set
    [52] - ITT Analysis Set
    [53] - ITT Analysis Set
    [54] - ITT Analysis Set
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide/Clindamycin + vehicle cream
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.652
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Benzoyl peroxide gel + Tazarotene
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.279
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Clindamycin gel + Tazarotene
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.312
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + Tazarotene
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Benzoyl peroxide/Clindamycin + Tazarotene v Vehicle gel + vehicle cream
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    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 adverse events (AEs) were collected from Day 1 up to Day 89.
    Adverse event reporting additional description
    SAEs and non-serious AEs were assessed in the ITT Analysis Set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Benzoyl peroxide/Clindamycin + Tazarotene
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Benzoyl peroxide/Clindamycin + vehicle cream
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Benzoyl peroxide gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Clindamycin gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Vehicle gel + Tazarotene
    Reporting group description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Reporting group title
    Vehicle gel + vehicle cream
    Reporting group description
    		 Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.

    Serious adverse events
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Benzoyl peroxide/Clindamycin + Tazarotene Benzoyl peroxide/Clindamycin + vehicle cream Benzoyl peroxide gel + Tazarotene Clindamycin gel + Tazarotene Vehicle gel + Tazarotene Vehicle gel + vehicle cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 106 (23.58%)
    22 / 105 (20.95%)
    24 / 107 (22.43%)
    18 / 108 (16.67%)
    29 / 106 (27.36%)
    12 / 55 (21.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibromatosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Application site burn
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Application site dermatitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Application site discolouration
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Application site dryness
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    1 / 108 (0.93%)
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    1
    1
    1
    1
    Application site erythema
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    2 / 107 (1.87%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    0
    2
    1
    0
    1
    Application site exfoliation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Application site irritation
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    3 / 107 (2.80%)
    4 / 108 (3.70%)
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    3
    4
    2
    0
    Application site pain
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    2 / 107 (1.87%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Application site pruritus
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    2 / 106 (1.89%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    Condition aggravated
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Cyst
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Local swelling
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pain
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    Allergy to metals
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Food allergy
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Multiple allergies
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    3 / 107 (2.80%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Investigations
    Smear cervix abnormal
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 107 (0.93%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    Facial bones fracture
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Joint sprain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    Insomnia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Lip blister
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Tooth impacted
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Skin irritation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Furuncle
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    Localised infection
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lyme disease
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 106 (2.83%)
    3 / 105 (2.86%)
    3 / 107 (2.80%)
    5 / 108 (4.63%)
    4 / 106 (3.77%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    3
    5
    4
    3
    Oral herpes
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 105 (0.95%)
    2 / 107 (1.87%)
    0 / 108 (0.00%)
    1 / 106 (0.94%)
    2 / 55 (3.64%)
         occurrences all number
    1
    1
    2
    0
    1
    2
    Tinea pedis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 105 (0.95%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 106 (4.72%)
    4 / 105 (3.81%)
    5 / 107 (4.67%)
    2 / 108 (1.85%)
    4 / 106 (3.77%)
    1 / 55 (1.82%)
         occurrences all number
    5
    4
    5
    2
    4
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    1 / 107 (0.93%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Vaginitis bacterial
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    1 / 108 (0.93%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 105 (0.00%)
    0 / 107 (0.00%)
    0 / 108 (0.00%)
    0 / 106 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2008
    21 Aug 2008 In Section 7.2, Inclusion criterion #3, was updated “ To Allow up to 80 inflammatory lesions (increased from 60), and up to 3 nodules of no more than 5 millimeter (mm) each (increased from none).” In Section 7.2, Inclusion criterion #7 was removed. In Section 7.3, Exclusion criterion #3, was updated “To Allow subjects with seborrheic dermatitis if it has been inactive for at least a year and/or does not affect the face.” In Section 12.1.3, “Additional endpoints were revised to include a 2-grade drop in ISGA from Baseline to weeks 2, 4, and 8.” In Section 12.4.5.3, “Definition of statistical analysis to be used for the additional endpoint of the proportion of subjects with an ISGA score of 0 or 1 at weeks 2, 4, and 8 was added.”

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

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