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    Clinical Trial Results:
    Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea

    Summary
    EudraCT number
    		 2012-005686-12
    Trial protocol
    		 GB   SE   DE  
    Global end of trial date
    14 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2020
    First version publication date
    22 Oct 2020
    Other versions
    Summary report(s)
    		 2012-005686-12

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.29107
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01885000
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D
    Sponsor organisation address
    2400 route des colles, Biot, France, 06410
    Public contact
    CTA Coordinator, Galderma R&D, 33 (0)493 95 70 85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma R&D, 33 (0)493 95 70 85, cta.coordinator@galderma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the subject-reported outcomes following the treatment of severe facial erythema of rosacea with brimonidine tartrate 0.5 percent (%) gel compared with vehicle gel. The safety and efficacy of the two treatment regimens were also evaluated.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 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
    Sweden: 10
    Country: Number of subjects enrolled
    United Kingdom: 26
    Country: Number of subjects enrolled
    Germany: 56
    Worldwide total number of subjects
    92
    EEA total number of subjects
    92
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    71
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No screening

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Brimonidine Tartrate 0.5% gel
    Arm description
    		 Subjects applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brimonidine tartrate
    Investigational medicinal product code
    Other name
    Mirvaso
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Brimonidine tartrate was applied cutaneously once daily for 8 days.

    Arm title
    		 Vehicle
    Arm description
    		 Subjects applied brimonidine tartrate vehicle gel topically once daily for 8 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Brimonidine tartrate vehicle gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.

    Number of subjects in period 1
    		Brimonidine Tartrate 0.5% gel Vehicle
    Started
    48
    44
    Completed
    46
    42
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    -
         Protocol violation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brimonidine Tartrate 0.5% gel
    Reporting group description
    		 Subjects applied brimonidine tartrate 0.5% gel topically once daily for 8 days.

    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects applied brimonidine tartrate vehicle gel topically once daily for 8 days.

    Reporting group values
    		 Brimonidine Tartrate 0.5% gel Vehicle Total
    Number of subjects
    		 48 44 92
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 37 34 71
        From 65-84 years
    		 11 10 21
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.4 ( 12.9 ) 54.9 ( 12.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 26 56
        Male
    		 18 18 36
    Race
    Units: Subjects
        White
    		 48 44 92
    Skin phototype
    Units: Subjects
        Type I
    		 3 6 9
        Type II
    		 34 27 61
        Type III
    		 11 11 22

    End points

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    End points reporting groups
    Reporting group title
    Brimonidine Tartrate 0.5% gel
    Reporting group description
    		 Subjects applied brimonidine tartrate 0.5% gel topically once daily for 8 days.

    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects applied brimonidine tartrate vehicle gel topically once daily for 8 days.

    Primary: Percentage of Subjects who are Very satisfied/satisfied/somewhat satisfied with the Overall Study Treatment

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    End point title
    		 Percentage of Subjects who are Very satisfied/satisfied/somewhat satisfied with the Overall Study Treatment
    End point description
    Percentage of subjects who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported. Intent-to-Treat (ITT) population consisted of the entire population enrolled and randomized. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    46
    42
    Units: Percentage of subjects
        number (not applicable)
    69.6
    40.4
    Statistical analysis title
    		 Brimonidine Tartrate 0.5% gel versus Vehicle
    Comparison groups
    Brimonidine Tartrate 0.5% gel v Vehicle
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0065
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Primary: EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8

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    End point title
    		 EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
    End point description
    EQ-5D-3L questionnaire validated questionnaire addressed 5 questions on 1. mobility, 2.self-care, 3.usual activities, 4.pain/discomfort and 5. anxiety/depression. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    46
    42
    Units: Percentage of subjects
    number (not applicable)
        1. I have no problems in walking about
    95.7
    92.9
        1.I have some problems in walking about
    4.3
    7.1
        2. I have no problems with self-care
    97.8
    97.6
        2. I have some problems washing or dressing myself
    2.2
    2.4
        3.I have no problems with performing usualactivity
    91.3
    90.5
        3.I have some problems withperformingusualactivity
    8.7
    9.5
        4.I have no pain or discomfort
    58.7
    76.2
        4.I have moderate pain or discomfort
    41.3
    21.4
        4.I have extreme pain or discomfort
    0
    2.4
        5.I am not anxious or depressed
    87.0
    73.8
        5.I am moderately anxious or depressed
    10.9
    26.2
        5.I am extremely anxious or depressed
    2.2
    0
    Statistical analysis title
    		 Mobility
    Comparison groups
    Vehicle v Brimonidine Tartrate 0.5% gel
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5821
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Self-Care
    Comparison groups
    Brimonidine Tartrate 0.5% gel v Vehicle
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8864
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Usual Activities
    Comparison groups
    Brimonidine Tartrate 0.5% gel v Vehicle
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9579
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Pain/Discomfort
    Comparison groups
    Brimonidine Tartrate 0.5% gel v Vehicle
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1344
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Anxiety/Depression
    Comparison groups
    Vehicle v Brimonidine Tartrate 0.5% gel
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1881
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Primary: Percent Change from Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8

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    End point title
    		 Percent Change from Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
    End point description
    DLQI is a compact health-related quality of life index that has 10 questions and depends on the patients’ self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. [Grade 0-1]: No effect at all on subject's life, [Grade 2-5]: Small effect at all on subject's life, [Grade 6-10]: Moderate effect at all on subject's life, [Grade 11-20]: Very large effect at all on subject's life, [Grade 21-30]: Extremely large effect at all on subject's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Baseline and Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    45
    41
    Units: Score on scale
        arithmetic mean (standard deviation)
    -15.4 ( 61.7 )
    -32.6 ( 43.7 )
    Statistical analysis title
    		 % change from Baseline in Total Score
    Comparison groups
    Brimonidine Tartrate 0.5% gel v Vehicle
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3935
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Primary: EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along with a Visual Analogue Score for the Overall Health State) at Day 8

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    End point title
    		 EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along with a Visual Analogue Score for the Overall Health State) at Day 8
    End point description
    EQ-5D-3L questionnaire validated questionnaire (along with a visual analogue score for the overall health state) was reported. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    45
    42
    Units: Score on scale
        arithmetic mean (standard deviation)
    76.0 ( 19.3 )
    80.2 ( 13.1 )
    Statistical analysis title
    		 EQ-5D-3L: Health State Today
    Comparison groups
    Brimonidine Tartrate 0.5% gel v Vehicle
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4162
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects With at Least two Grade Improvement in the Clinician's Erythema Assessment (CEA)

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    End point title
    		 Percentage of Subjects With at Least two Grade Improvement in the Clinician's Erythema Assessment (CEA)
    End point description
    Percentage of subjects with at least one grade improvement in the CEA was reported. Evaluation of erythema by using CEA was assessed by 0 to 4 grades, where 0-Clear skin with no signs of erythema, 1-Almost clear; slight redness, 2-Mild erythema; definite redness, 3-Moderate erythema; marked redness, 4-Severe erythema; fiery redness. ITT population consisted of the entire population enrolled and randomized. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    46
    42
    Units: Percentage of subjects
        number (not applicable)
    47.8
    7.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least two Grade Improvement in the Patient Self-assessment

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    End point title
    		 Percentage of Subjects With at Least two Grade Improvement in the Patient Self-assessment
    End point description
    Percentage of subjects with at least two grade improvement in the PSA was reported. Evaluation of erythema severity by using the PSA grades (0-4): 0- No redness, 1- very mild redness, 2-mild redness, 3-moderate redness, 4-severe redness. ITT population consisted of the entire population enrolled and randomized. Here 'N' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    46
    42
    Units: percentage of subjects
        number (not applicable)
    41.3
    23.8
    No statistical analyses for this end point

    Secondary: Change from Baseline in Facial inflammatory lesion counts at Day 8

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    End point title
    		 Change from Baseline in Facial inflammatory lesion counts at Day 8
    End point description
    Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator. Here 'n' number of subjects anlaysed signifies number of subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    46
    42
    Units: number of lesions
        arithmetic mean (standard deviation)
    0.3 ( 2.5 )
    0.4 ( 1.4 )
    No statistical analyses for this end point

    Secondary: Number of Subjects Reported Adverse Events

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    End point title
    		 Number of Subjects Reported Adverse Events
    End point description
    Number of subjects with AE’s were reported. All Patient Treated (APT) population included all subjects enrolled in the study who had received the study treatment at least once.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to Day 8
    End point values
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Number of subjects analysed
    48
    44
    Units: count of subjects
    15
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to Day 8
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Brimonidine Tartrate 0.5% gel
    Reporting group description
    		 -

    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects applied brimonidine tartrate vehicle gel topically once daily for 8 days.

    Serious adverse events
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Brimonidine Tartrate 0.5% gel Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 48 (31.25%)
    9 / 44 (20.45%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 44 (4.55%)
         occurrences all number
    1
    2
    Hypoesthesia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    6 / 48 (12.50%)
    2 / 44 (4.55%)
         occurrences all number
    6
    2
    Pain of skin
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Skin burning sensation
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 44 (4.55%)
         occurrences all number
    0
    2
    Rosacea
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 44 (2.27%)
         occurrences all number
    2
    1
    Skin irritation
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Skin tightness
         subjects affected / exposed
    4 / 48 (8.33%)
    2 / 44 (4.55%)
         occurrences all number
    5
    3
    Skin warm
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 44 (2.27%)
         occurrences all number
    9
    2
    Swelling face
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Rash pustular
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26416154
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