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    Clinical Trial Results:
    Effect of CD07805/47 gel in subjects presenting with flushing related to erythematotelangiectatic or papulopustular rosacea

    Summary
    EudraCT number
    		 2013-005083-26
    Trial protocol
    		 DE  
    Global end of trial date
    30 Jun 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.40225E
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02300129
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D SNC
    Sponsor organisation address
    Les Templiers, 2400 Route des Colles , Biot, France, 06410
    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
    12 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    − to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in controlled condition; − to demonstrate that CD07805/47 0.5% gel is able to prevent a flush whatever the trigger in everyday life condition; − to investigate if reduction in redness is associated with a decrease in skin sensations such as heat, burning/stinging, skin tension and sweating; − to demonstrate that such efficacy on transient redness and sensations takes place in both populations (rosacea type I and rosacea type II).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    14 Apr 2014
    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
    Germany: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    32
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 1 investigative site in Germany from 14 April 2014 to 30 June 2014

    Pre-assignment
    Screening details
    		 A total of 46 subjects were screened, 34 were randomised for Period 1, and 32 participated in Period 2.

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

    Arms
    Arm title
    		 flush model
    Arm description
    		 The period 1 (1 week) includes cross-over (first and third sessions) and split face design (second session). During this period, the study drugs are applied as follows: placebo gel on both sides on face; one side of the face treated with CD07805/47 0.5% gel and the other side with CD07805/47 placebo gel (allocation of treatment on each half-face is randomized) CD07805/47 0.5% gel on both sides on face
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brimonidine tartrate
    Investigational medicinal product code
    CD07805/47
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    CD07805/47 0.5% gel

    Investigational medicinal product name
    CD07805/47 placebo Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    placebo gel

    Number of subjects in period 1 [1]
    		flush model
    Started
    33
    Completed
    32
    Not completed
    1
         Consent withdrawn by subject
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was excluded from ITT (intent to treat) population because he didn't perform any efficacy assessment during the study so N=33 instead fo 34 subjects
    Period 2
    Period 2 title
    Cross over
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 CD07805/47 0.5% gel cross over
    Arm description
    		 The period 2 (4 weeks) corresponds to a cross-over design. The CD07805/47 0.5% gel is applied once a day on the whole face and then the CD07805/47 placebo gel for the 2 following weeks or inversely according to randomisation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brimonidine tartrate
    Investigational medicinal product code
    CD07805/47
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    CD07805 0.5% gel once a day during 2 weeks

    Arm title
    		 CD07805/47 Placebo gel cross-over
    Arm description
    		 The period 2 (4 weeks) corresponds to a cross-over design. The CD07805/47 0.5% gel is applied once a day on the whole face and then the CD07805/47 placebo gel for the 2 following weeks or inversely according to randomization
    Arm type
    		 Placebo

    Investigational medicinal product name
    CD07805/47 Placebo gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    placebo once a day during 2 weeks

    Number of subjects in period 2
    		CD07805/47 0.5% gel cross over CD07805/47 Placebo gel cross-over
    Started
    32
    32
    Completed
    31
    31
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Flush model
    Reporting group description
    		 -

    Reporting group values
    		 Flush model Total
    Number of subjects
    		 33 33
    Age categorical
    All subjects included in Period 1 (flush model)
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 31 31
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.2 ( 10.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    flush model
    Reporting group description
    		 The period 1 (1 week) includes cross-over (first and third sessions) and split face design (second session). During this period, the study drugs are applied as follows: placebo gel on both sides on face; one side of the face treated with CD07805/47 0.5% gel and the other side with CD07805/47 placebo gel (allocation of treatment on each half-face is randomized) CD07805/47 0.5% gel on both sides on face
    Reporting group title
    CD07805/47 0.5% gel cross over
    Reporting group description
    		 The period 2 (4 weeks) corresponds to a cross-over design. The CD07805/47 0.5% gel is applied once a day on the whole face and then the CD07805/47 placebo gel for the 2 following weeks or inversely according to randomisation

    Reporting group title
    CD07805/47 Placebo gel cross-over
    Reporting group description
    		 The period 2 (4 weeks) corresponds to a cross-over design. The CD07805/47 0.5% gel is applied once a day on the whole face and then the CD07805/47 placebo gel for the 2 following weeks or inversely according to randomization

    Primary: total number of flushes for each 2-week period in Period 2

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    End point title
    		 total number of flushes for each 2-week period in Period 2
    End point description
    The primary efficacy endpoint of this study was the total number of flushes reported in the subject diary for each 2-week period in Period 2.
    End point type
    Primary
    End point timeframe
    Day 22 Day 36/Early termination
    End point values
    		 CD07805/47 0.5% gel cross over CD07805/47 Placebo gel cross-over
    Number of subjects analysed
    31 [1]
    31 [2]
    Units: flushes count
        arithmetic mean (standard deviation)
    15.3 ( 12.1 )
    16.3 ( 14 )
    Notes
    [1] - One subject was excluded from ITT (Intent to treat) population (no efficacy assessment performed)
    [2] - One subject was excluded from ITT (Intent to treat) population (no efficacy assessment performed)
    Statistical analysis title
    		 CD07805/47 0.5% gel vs CD07805/47 Placebo gel
    Statistical analysis description
    31 subjects were in this analysis based on 62 values
    Comparison groups
    CD07805/47 0.5% gel cross over v CD07805/47 Placebo gel cross-over
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.742 [3]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [3] - P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5 % (two-sided) Analysis of variance including sequence, subject (sequence), period and treatment as factor in the model.

    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. Adverse event reporting additional description:
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Split Face design Period 1
    Reporting group description
    		 -

    Reporting group title
    Cross over design period 1
    Reporting group description
    		 -

    Reporting group title
    Cross-over design Period 2
    Reporting group description
    		 -

    Serious adverse events
    		 Split Face design Period 1 Cross over design period 1 Cross-over design Period 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Split Face design Period 1 Cross over design period 1 Cross-over design Period 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 34 (2.94%)
    5 / 32 (15.63%)
    Nervous system disorders
    Headache
    Additional description: non cutaneous adverse event
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Eye disorders
    erythema of eyelid
    Additional description: Adverse event not related to CD07805/47 0,5% gel
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Cheilitis
    Additional description: Adverse event not related to CD07805 0.5% gel
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Oral herpes
    Additional description: Adverse event not related to CD07805/47 0.5% gel
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
    Additional description: Non cutaneous adverse event
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    erythema and skin tightness
    Additional description: cutaneous adverse event related to CD07805/47 0.5% gel
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 32 (0.00%)
         occurrences all number
    0
    2
    0
    erythema, papules and pruritus
    Additional description: During the split face design period 1, cutaneous adverse events were related to CD07805 placebo gel During the cross over design period 2, adverse events of special interest were related to CD07805/47 0.5% gel leading to subject discontinuation
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    6
    0
    3

    More information

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

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

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