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    Clinical Trial Results:
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL GROUP STUDY TO DEMONSTRATE THE EFFICACY AND ASSESS THE SAFETY OF CD07805/47 GEL 0.5% APPLIED TOPICALLY ONCE DAILY IN SUBJECTS WITH MODERATE TO SEVERE FACIAL ERYTHEMA OF ROSACEA

    Summary
    EudraCT number
    		 2012-001044-22
    Trial protocol
    		 SE  
    Global end of trial date
    18 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Feb 2016
    First version publication date
    04 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.40174
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01789775
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D SNC
    Sponsor organisation address
    Les Templiers, 2400 Route des Colles, Biot, France,
    Public contact
    CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85 , cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma R&D SNC, +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
    19 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate efficacy and to assess the safety of CD07805/47 gel 0.5%, applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe facial erythema of rosacea.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Sep 2012
    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: 6
    Country: Number of subjects enrolled
    Russian Federation: 92
    Country: Number of subjects enrolled
    France: 14
    Worldwide total number of subjects
    112
    EEA total number of subjects
    20
    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)
    107
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 8 investigational centers located in France, Russia, and Sweden. from 28 Dec 2012 to 18 Oct 2013.

    Pre-assignment
    Screening details
    		 A total of 130 subjects were screened and 112 subjects were randomized in a 1:1 ratio to receive either CD07805/47 Gel 0.5% or Vehicle Gel for once daily application.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CD07805/47 0.5% Gel
    Arm description
    		 Subject who received Brimonidine (CD07805/47), gel cutaneous use, once application on the face for a period of 29 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brimonidine tartrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0.5%

    Arm title
    		 Placebo Gel
    Arm description
    		 Subject who received Matching Placebo gel, gel cutaneous use, once application on the face for a period of 29 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    0%

    Number of subjects in period 1
    		CD07805/47 0.5% Gel Placebo Gel
    Started
    57
    55
    Completed
    50
    53
    Not completed
    7
    2
         Adverse event, non-fatal
    6
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CD07805/47 0.5% Gel
    Reporting group description
    		 Subject who received Brimonidine (CD07805/47), gel cutaneous use, once application on the face for a period of 29 days

    Reporting group title
    Placebo Gel
    Reporting group description
    		 Subject who received Matching Placebo gel, gel cutaneous use, once application on the face for a period of 29 days

    Reporting group values
    		 CD07805/47 0.5% Gel Placebo Gel Total
    Number of subjects
    		 57 55 112
    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)
    		 56 51 107
        From 65-84 years
    		 1 4 5
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.2 ± 10.8 44.9 ± 12.1 -
    Gender categorical
    Units: Subjects
        Female
    		 41 40 81
        Male
    		 16 15 31

    End points

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    End points reporting groups
    Reporting group title
    CD07805/47 0.5% Gel
    Reporting group description
    		 Subject who received Brimonidine (CD07805/47), gel cutaneous use, once application on the face for a period of 29 days

    Reporting group title
    Placebo Gel
    Reporting group description
    		 Subject who received Matching Placebo gel, gel cutaneous use, once application on the face for a period of 29 days

    Primary: Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

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    End point title
    		 Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
    End point description
    Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
    End point type
    Primary
    End point timeframe
    Day 29 at Hours 3, 5, 7, and 9
    End point values
    		 CD07805/47 0.5% Gel Placebo Gel
    Number of subjects analysed
    57
    55
    Units: Participants
        Hour 3
    48
    32
        Hour 5
    46
    33
        Hour 7
    43
    35
        Hour 9
    39
    33
    Statistical analysis title
    		 Statistical analysis on primary endpoint
    Comparison groups
    CD07805/47 0.5% Gel v Placebo Gel
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0483
    Method
    		 Generalized Estimating Equation (GEE)
    Confidence interval

    Secondary: Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

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    End point title
    		 Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
    End point description
    Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
    End point type
    Secondary
    End point timeframe
    Day 1 - 30 minutes after application
    End point values
    		 CD07805/47 0.5% Gel Placebo Gel
    Number of subjects analysed
    57
    55
    Units: participants
    27
    7
    Statistical analysis title
    		 Statistical analysis on secondary endpoint
    Comparison groups
    CD07805/47 0.5% Gel v Placebo Gel
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The collection of AEs is from the time that a subject signs the ICF to their final visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    CD07805/47 0.5% Gel
    Reporting group description
    		 Subject who received Brimonidine (CD7805/47), 0.5% gel cutaneous use,

    Reporting group title
    Placebo gel
    Reporting group description
    		 -

    Serious adverse events
    		 CD07805/47 0.5% Gel Placebo gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Angioedema/urticaria
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 CD07805/47 0.5% Gel Placebo gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 57 (28.07%)
    3 / 55 (5.45%)
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Erythema
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 55 (0.00%)
         occurrences all number
    3
    0
    Pruritus
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 55 (0.00%)
         occurrences all number
    0
    0
    Rosacea
         subjects affected / exposed
    7 / 57 (12.28%)
    1 / 55 (1.82%)
         occurrences all number
    7
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jul 2013
    specific protocol amendment for France : inclusion criteria n°5 (Female of childbearing potential). Updates according to local requirement: addition of an exclusion criteria (n°18) for adults protected by the law); process for reporting of SUSAR in France was further elaborate; exclusion of French sites for facial photographs

    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.
    not applicable
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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