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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
    2015-002540-13
    Trial protocol
    HU   ES   CZ  
    Global end of trial date
    12 May 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Jan 2020
    First version publication date
    11 Jan 2020
    Other versions
    Summary report(s)
    Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.06.SPR.18252
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02556788
    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
    31 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 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
    23 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
    Spain: 28
    Country: Number of subjects enrolled
    Ukraine: 145
    Country: Number of subjects enrolled
    United States: 278
    Country: Number of subjects enrolled
    Czech Republic: 123
    Country: Number of subjects enrolled
    Hungary: 140
    Country: Number of subjects enrolled
    Poland: 188
    Country: Number of subjects enrolled
    Romania: 129
    Country: Number of subjects enrolled
    Russian Federation: 181
    Worldwide total number of subjects
    1212
    EEA total number of subjects
    608
    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)
    15
    Adolescents (12-17 years)
    555
    Adults (18-64 years)
    642
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 1212 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 Trial (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
    602
    610
    Completed
    558
    573
    Not completed
    44
    37
         Other
    -
    1
         Protocol violation
    4
    1
         Lack of efficacy
    -
    1
         Pregnancy
    1
    1
         Adverse event, non-fatal
    9
    1
         Other reasons
    3
    -
         Consent withdrawn by subject
    18
    21
         Lost to follow-up
    9
    11

    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
    602 610 1212
    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)
    9 6 15
        Adolescents (12-17 years)
    267 288 555
        Adults (18-64 years)
    326 316 642
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    19.6 ± 6.20 19.9 ± 6.38 -
    Gender categorical
    Units: Subjects
        Female
    357 338 695
        Male
    245 272 517

    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 Inflammatory Lesion Count (Face)

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    End point title
    Absolute Change in Inflammatory Lesion Count (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
    602
    610
    Units: Absolute Change in Lesions
        least squares mean (standard error)
    -24.2 ± 0.51
    -18.7 ± 0.51
    Statistical analysis title
    Change in Facial Inflammatory Lesion Counts
    Comparison groups
    CD5789 50 microgram/g cream v Vehicle cream
    Number of subjects included in analysis
    1212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.9
         upper limit
    -4.3
    Variability estimate
    Standard deviation

    Primary: Absolute Change in Non Inflammatory Lesions (Face)

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    End point title
    Absolute Change in Non Inflammatory Lesions (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
    602
    610
    Units: Absolute Change in Lesions
        least squares mean (standard error)
    -30.1 ± 0.71
    -21.6 ± 0.71
    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
    1212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -8.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.3
         upper limit
    -6.6
    Variability estimate
    Standard deviation

    Primary: IGA Success Rate

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    End point title
    IGA Success Rate
    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
    602
    610
    Units: Percentage
        number (not applicable)
    42.3
    25.7
    Statistical analysis title
    IGA Success Rate
    Comparison groups
    CD5789 50 microgram/g cream v Vehicle cream
    Number of subjects included in analysis
    1212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    16.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.3
         upper limit
    22
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Week 12
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Vehicle
    Reporting group description
    -

    Reporting group title
    CD5789 50 microgram/gram
    Reporting group description
    -

    Serious adverse events
    Vehicle CD5789 50 microgram/gram
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 609 (0.66%)
    2 / 602 (0.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Ligament Sprain
         subjects affected / exposed [1]
    1 / 1 (100.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed [2]
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide Attempt
         subjects affected / exposed [3]
    1 / 1 (100.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed [4]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sinusitis
         subjects affected / exposed [5]
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed [6]
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Vehicle CD5789 50 microgram/gram
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 609 (3.45%)
    45 / 602 (7.48%)
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed [7]
    0 / 1 (0.00%)
    2 / 2 (100.00%)
         occurrences all number
    0
    2
    Drug administered at inappropriate site
         subjects affected / exposed [8]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Investigations
    Blood bilirubin increased
         subjects affected / exposed [9]
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Blood creatine increased
         subjects affected / exposed [10]
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed [11]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Eye disorders
    Eyelid exfoliation
         subjects affected / exposed [12]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Eyelid oedema
         subjects affected / exposed [13]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site irritation
         subjects affected / exposed [14]
    0 / 1 (0.00%)
    15 / 15 (100.00%)
         occurrences all number
    0
    15
    Application site pruritus
         subjects affected / exposed [15]
    2 / 2 (100.00%)
    5 / 5 (100.00%)
         occurrences all number
    2
    5
    Application site pain
         subjects affected / exposed [16]
    0 / 1 (0.00%)
    4 / 4 (100.00%)
         occurrences all number
    0
    4
    Application site dryness
         subjects affected / exposed [17]
    0 / 1 (0.00%)
    3 / 3 (100.00%)
         occurrences all number
    0
    3
    Application site erosion
         subjects affected / exposed [18]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Application site erythema
         subjects affected / exposed [19]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Cheilitis
         subjects affected / exposed [20]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed [21]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed [22]
    0 / 1 (0.00%)
    2 / 2 (100.00%)
         occurrences all number
    0
    2
    Skin fissures
         subjects affected / exposed [23]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Herpes simplex
         subjects affected / exposed [24]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Tinea versicolour
         subjects affected / exposed [25]
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed [26]
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Notes
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is correct as reported.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2017
    Major changes included in the Protocol: 1. Increase in the number of investigational centers from 75 to 85 centers 2. Russian Minister of Health request to edit wording of inclusion criteria number 1 to better reflect the age groups. 3. Japan was removed from the region(s)/countries involved in the study
    24 Feb 2017
    Major changes included in the PIP: Due to the unexpected slow recruitment for subjects aged less 14 years old and 14 to 17 years old: a. Extension of study completion from October 2016 to August 2017; b. Modification of the agreed paediatric investigation plan to decrease the number of paediatric subjects enrollment. Request was accepted by the Pediatric Committee.

    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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