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    Clinical Trial Results:
    A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50μg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris

    Summary
    EudraCT number
    		 2016-002860-15
    Trial protocol
    		 DE   CZ  
    Global end of trial date
    14 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2019
    First version publication date
    06 Apr 2019
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.06.SPR.18251
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02566369
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma S.A.
    Sponsor organisation address
    Avenue Gratta-Paille 2, Lausanne, Switzerland, 1018
    Public contact
    CTA Coordinator, Galderma S.A., +41 21 642 78 00, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma S.A., +41 21 642 78 00, cta.coordinator@galderma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001492-PIP01-13
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    17 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Multi-center, randomized, double blind, vehicle controlled study, to assess the efficacy and safety of CD5789 50 microgram/g cream in subjects 9 years of age and older with moderate acne vulgaris on face and trunk, when applied once daily for 12 weeks.
    Protection of trial subjects
    All subjects were required to read and sign an informed consent. The subjects could withdraw from the treatment at any time and for any reason.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    30 Nov 2015
    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: 124
    Country: Number of subjects enrolled
    Hungary: 88
    Country: Number of subjects enrolled
    United States: 802
    Country: Number of subjects enrolled
    Canada: 139
    Country: Number of subjects enrolled
    Puerto Rico: 55
    Worldwide total number of subjects
    1208
    EEA total number of subjects
    212
    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)
    19
    Adolescents (12-17 years)
    573
    Adults (18-64 years)
    616
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 1208 subjects were enrolled and exposed to CD5789 50 microgram/g cream or vehicle cream for 12 weeks. A minimum of 14 days between Screening and Baseline visit (+/- 3 days). Study visits for Weeks 1,2,4,8 (+/- 3 days) and Week 12 (+/- 5 days).

    Pre-assignment
    Screening details
    		 Male or Female subjects, 9 years of age and older, with moderate acne vulgaris, with at least 20 inflammatory lesions and 25 non-inflammatory lesions for face, and , at least 20 inflammatory and 20- 100 non-inflammatory on the trunk. No more than 1 nodule on the face and trunk. Inclusion criteria for trunk was optional for subjects ages 9 to 11.

    Period 1
    Period 1 title
    Overall (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
    		 CD5789 50 microgram/g cream
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CD5789 50 microgram/g cream
    Investigational medicinal product code
    CD5789
    Other name
    trifarotene
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    A thin layer of study product cream (one pump actuation) was applied to the face region: forehead, nose, chin, area between the nose and upper lip, and each cheek. Avoid application proximity in/close to eyes, angles of mouth, lips and mucous membranes. A thin layer of study product cream (two pump actuations) was applied to the truncal region: right and left upper back, right and left shoulders and right and left anterior chest, self-reachable by the subject. Avoid application to axillary region, anterior and posterior neck. Apply daily, in the evening, for 12 weeks, after washing the treated areas with preferred mild or soapless cleanser and allow to fully dry before applying study drug. The use of non comedogenic moisturizer was encouraged to be used as desired but respecting an interval of 1 hour (before and after) study drug application.

    Arm title
    		 Vehicle cream
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle cream
    Investigational medicinal product code
    N/A
    Other name
    placebo
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    A thin layer of study product cream (one pump actuation) was applied to the face region: forehead, nose, chin, area between the nose and upper lip, and each cheek. Avoid application proximity in/close to eyes, angles of mouth, lips and mucous membranes. A thin layer of study product cream (two pump actuations) was applied to the truncal region: right and left upper back, right and left shoulders and right and left anterior chest, self-reachable by the subject. Avoid application to axillary region, anterior and posterior neck. Apply daily, in the evening, for 12 weeks, after washing the treated areas with preferred mild or soapless cleanser and allow to fully dry before applying study drug. The use of non comedogenic moisturizer was encouraged to be used as desired but respecting an interval of 1 hour (before and after) study drug application.

    Number of subjects in period 1
    		CD5789 50 microgram/g cream Vehicle cream
    Started
    612
    596
    Completed
    540
    535
    Not completed
    72
    61
         Consent withdrawn by subject
    39
    32
         Adverse event, non-fatal
    14
    1
         Protocol violation
    3
    1
         Other
    2
    1
         Pregnancy
    -
    2
         Lost to follow-up
    13
    23
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CD5789 50 microgram/g cream
    Reporting group description
    		 -

    Reporting group title
    Vehicle cream
    Reporting group description
    		 -

    Reporting group values
    		 CD5789 50 microgram/g cream Vehicle cream Total
    Number of subjects
    		 612 596 1208
    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)
    		 10 9 19
        Adolescents (12-17 years)
    		 304 269 573
        Adults (18-64 years)
    		 298 318 616
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.6 ± 6.88 19.3 ± 5.89 -
    Gender categorical
    Units: Subjects
        Female
    		 305 324 629
        Male
    		 307 272 579

    End points

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    End points reporting groups
    Reporting group title
    CD5789 50 microgram/g cream
    Reporting group description
    		 -

    Reporting group title
    Vehicle cream
    Reporting group description
    		 -

    Primary: Absolute Change in Facial Inflammatory Lesion Count

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    End point title
    		 Absolute Change in Facial Inflammatory Lesion Count
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 CD5789 50 microgram/g cream Vehicle cream
    Number of subjects analysed
    612
    596
    Units: Absolute Change in Lesion Counts
        least squares mean (standard error)
    -19.0 ± 0.50
    -15.4 ± 0.51
    Statistical analysis title
    		 Absolute Change in Inflammtory Lesion Count (Face)
    Comparison groups
    CD5789 50 microgram/g cream v Vehicle cream
    Number of subjects included in analysis
    1208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9
         upper limit
    		 -2.2

    Primary: Absolute Change in Facial Non Inflammatory Lesions

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    End point title
    		 Absolute Change in Facial Non Inflammatory Lesions
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 CD5789 50 microgram/g cream Vehicle cream
    Number of subjects analysed
    612
    596
    Units: Absolute Change in Lesion Counts
        least squares mean (standard error)
    -25.0 ± 0.87
    -17.9 ± 0.87
    Statistical analysis title
    		 Absolute Change in Non-Inflammatory (Face)
    Comparison groups
    CD5789 50 microgram/g cream v Vehicle cream
    Number of subjects included in analysis
    1208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 -4.8

    Primary: IGA Success Rate (Face)

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    End point title
    		 IGA Success Rate (Face)
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 CD5789 50 microgram/g cream Vehicle cream
    Number of subjects analysed
    612
    596
    Units: Percentage
        number (not applicable)
    29.4
    19.5
    Statistical analysis title
    		 IGA Success Rate
    Comparison groups
    CD5789 50 microgram/g cream v Vehicle cream
    Number of subjects included in analysis
    1208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.8
         upper limit
    		 14.8
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 12
    Adverse event reporting additional description
    Overall Summary of Treatment Emergent Adverse Events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    CD5789 50 microgram/g cream
    Reporting group description
    		 -

    Reporting group title
    Vehicle cream
    Reporting group description
    		 -

    Serious adverse events
    		 CD5789 50 microgram/g cream Vehicle cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 617 (0.65%)
    2 / 591 (0.34%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    1 / 617 (0.16%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural dizziness
         subjects affected / exposed
    1 / 617 (0.16%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hereditary angioedema
         subjects affected / exposed
    0 / 617 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 617 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infectious mononucleosis
         subjects affected / exposed
    1 / 617 (0.16%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 617 (0.16%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 617 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 CD5789 50 microgram/g cream Vehicle cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    209 / 617 (33.87%)
    123 / 591 (20.81%)
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    27 / 617 (4.38%)
    5 / 591 (0.85%)
         occurrences all number
    27
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 617 (0.97%)
    12 / 591 (2.03%)
         occurrences all number
    6
    12
    General disorders and administration site conditions
    Application site irritation
         subjects affected / exposed
    66 / 617 (10.70%)
    4 / 591 (0.68%)
         occurrences all number
    66
    4
    Application site puritus
         subjects affected / exposed
    24 / 617 (3.89%)
    8 / 591 (1.35%)
         occurrences all number
    24
    8
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    8 / 617 (1.30%)
    0 / 591 (0.00%)
         occurrences all number
    8
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    24 / 617 (3.89%)
    27 / 591 (4.57%)
         occurrences all number
    24
    27
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 617 (1.62%)
    8 / 591 (1.35%)
         occurrences all number
    10
    8
    Influenza
         subjects affected / exposed
    6 / 617 (0.97%)
    9 / 591 (1.52%)
         occurrences all number
    6
    9
    Sinusitis
         subjects affected / exposed
    6 / 617 (0.97%)
    1 / 591 (0.17%)
         occurrences all number
    6
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2016
    Increase in the number of study centers to 120 centers due to slow recruitment
    06 Mar 2017
    1.Increased the number of study centers in order to meet study completion deadline: a. 40 new sites in US, Canada and Puerto Rico b. 18 new sites in Europe, Germany and Hungary 2.Extended recruitment duration to 23 months

    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
    For support, Contact us.
    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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