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    Clinical Trial Results:
    Evaluation of Acne-Induced Hyperpigmentation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 µg/g Cream Versus Vehicle Cream Over 24 Weeks

    Summary
    EudraCT number
    		 2021-003608-41
    Trial protocol
    		 ES  
    Global end of trial date
    15 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2023
    First version publication date
    24 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.06.SPR.204245
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05089708
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma S.A.
    Sponsor organisation address
    Avenue Gratta-Paille 2, Lausanne, Switzerland, 1018
    Public contact
    Clinical Trial Information Desk, Galderma S.A., ctacoordinator@galderma.com
    Scientific contact
    Clinical Trial Information Desk, Galderma S.A., ctacoordinator@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?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Dec 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective is to evaluate the efficacy and safety of trifarotene 50 microgram per gram (µg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with acne-induced postinflammatory hyperpigmentation (PIH) in subjects with Fitzpatrick Skin Types (FST) I-VI.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice (GCP) as required by the International Conference for Harmonisation (ICH) guidelines. Compliance with these requirements also constitutes conformity with the ethical principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United States: 114
    Worldwide total number of subjects
    123
    EEA total number of subjects
    9
    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)
    33
    Adults (18-64 years)
    90
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 18 investigational centers in United States and Spain from 22 Dec 2021 to 15 Dec 2022.

    Pre-assignment
    Screening details
    		 A total of 123 subjects were randomized and enrolled in two treatment groups. 60 subjects in Trifarotene (CD5789) Cream treatment group and 63 subjects in Trifarotene Vehicle Cream treatment group.

    Period 1
    Period 1 title
    Overall Study (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
    		 Trifarotene Cream
    Arm description
    		 Subjects applied Trifarotene 50 (mcg/g) cream on face once daily in the evening for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trifarotene
    Investigational medicinal product code
    CD5789
    Other name
    Aklief
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Subjects applied a thin layer of trifarotene 50 mcg/g cream on the face once daily, in the evening for 24 weeks

    Arm title
    		 Trifarotene Vehicle Cream
    Arm description
    		 Subjects applied Trifarotene vehicle cream on face once daily in the evening for 24 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vehicle cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Subjects applied Trifarotene Vehicle cream on face once daily in the evening for 24 weeks.

    Number of subjects in period 1
    		Trifarotene Cream Trifarotene Vehicle Cream
    Started
    60
    63
    Completed
    45
    53
    Not completed
    15
    10
         Non-Compliance with Investigational Product
    1
    1
         Consent withdrawn by subject
    3
    1
         Consent withdrawn by parent or guardian
    2
    1
         Lost to follow-up
    9
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trifarotene Cream
    Reporting group description
    		 Subjects applied Trifarotene 50 (mcg/g) cream on face once daily in the evening for 24 weeks.

    Reporting group title
    Trifarotene Vehicle Cream
    Reporting group description
    		 Subjects applied Trifarotene vehicle cream on face once daily in the evening for 24 weeks.

    Reporting group values
    		 Trifarotene Cream Trifarotene Vehicle Cream Total
    Number of subjects
    		 60 63 123
    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)
    		 15 18 33
        Adults (18-64 years)
    		 45 45 90
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.7 ± 6.30 21.9 ± 5.95 -
    Gender categorical
    Units: Subjects
        Female
    		 45 48 93
        Male
    		 15 15 30
    Ethnicity categorical
    Units: Subjects
        Hispanic or Latino
    		 21 27 48
        Not Hispanic or Latino
    		 39 36 75
        Unknown or Not Reported
    		 0 0 0
    Race categorical
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 11 6 17
        Native Hawaiian or Other Pacific Islander
    		 0 2 2
        Black or African American
    		 22 23 45
        White
    		 25 31 56
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Trifarotene Cream
    Reporting group description
    		 Subjects applied Trifarotene 50 (mcg/g) cream on face once daily in the evening for 24 weeks.

    Reporting group title
    Trifarotene Vehicle Cream
    Reporting group description
    		 Subjects applied Trifarotene vehicle cream on face once daily in the evening for 24 weeks.

    Primary: Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24

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    End point title
    		 Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
    End point description
    The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1- present, but less than (<) mild; Grade 2- mild (slightly noticeable); Grade 3- between mild and moderate; Grade 4- moderate; Grade 5- between moderate and marked; Grade 6- marked (distinctive); Grade 7- between marked and severe; Grade 8- severe (very distinctive) with higher grade indicating severe pigmentation. . A negative change indicates a reduction in PIH disease severity score from baseline. The intent-to-Treat (ITT) population included all subjects who were randomized.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Trifarotene Cream Trifarotene Vehicle Cream
    Number of subjects analysed
    60
    63
    Units: score on a scale
        least squares mean (standard error)
    -2.1 ± 0.27
    -2.1 ± 0.24
    Statistical analysis title
    		 Absolute Change in PIH ODS Scores at Week 24
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8879
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent Change From Baseline in PIH ODS Scores at Week 24

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    End point title
    		 Percent Change From Baseline in PIH ODS Scores at Week 24
    End point description
    The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1- present, but less than (<) mild; Grade 2- mild (slightly noticeable); Grade 3- between mild and moderate; Grade 4- moderate; Grade 5- between moderate and marked; Grade 6- marked (distinctive); Grade 7- between marked and severe; Grade 8- severe (very distinctive) with higher grade indicating severe pigmentation. . A negative change indicates a reduction in PIH disease severity score from baseline. The intent-to-Treat (ITT) population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 Trifarotene Cream Trifarotene Vehicle Cream
    Number of subjects analysed
    60
    63
    Units: percent change
        least squares mean (standard error)
    -45.4 ± 5.73
    -44.9 ± 5.18
    Statistical analysis title
    		 % Change in PIH ODS Scores at Week 24
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9395
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20

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    End point title
    		 Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20
    End point description
    The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1- present, but less than (<) mild; Grade 2- mild (slightly noticeable); Grade 3- between mild and moderate; Grade 4- moderate; Grade 5- between moderate and marked; Grade 6- marked (distinctive); Grade 7- between marked and severe; Grade 8- severe (very distinctive) with higher grade indicating severe pigmentation. . A negative change indicates a reduction in PIH disease severity score from baseline. The intent-to-Treat (ITT) population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 16 and Week 20
    End point values
    		 Trifarotene Cream Trifarotene Vehicle Cream
    Number of subjects analysed
    60
    63
    Units: score on a scale
    least squares mean (standard error)
        Absolute Change at Week 12
    -1.6 ± 0.18
    -1.1 ± 0.17
        Absolute Change at Week 16
    -1.9 ± 0.2
    -1.7 ± 0.19
        Absolute Change at Week 20
    -2.0 ± 0.22
    -1.9 ± 0.21
    Statistical analysis title
    		 Absolute Change in PIH ODS Scores at Week 12
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.01
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Absolute Change in PIH ODS Scores at Week 16
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3332
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Absolute Change in PIH ODS Scores at Week 20
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6385
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20

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    End point title
    		 Percent Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20
    End point description
    The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1- present, but less than (<) mild; Grade 2- mild (slightly noticeable); Grade 3- between mild and moderate; Grade 4- moderate; Grade 5- between moderate and marked; Grade 6- marked (distinctive); Grade 7- between marked and severe; Grade 8- severe (very distinctive) with higher grade indicating severe pigmentation. . A negative change indicates a reduction in PIH disease severity score from baseline. The intent-to-Treat (ITT) population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, Week 16 and Week 20
    End point values
    		 Trifarotene Cream Trifarotene Vehicle Cream
    Number of subjects analysed
    60
    63
    Units: percent change
    least squares mean (standard error)
        Percent Change at Week 12
    -34.4 ± 3.78
    -23.6 ± 3.60
        Percent Change at Week 16
    -41.2 ± 4.35
    -36.1 ± 4.17
        Percent Change at Week 20
    -43.9 ± 4.83
    -41.0 ± 4.75
    Statistical analysis title
    		 % Change in PIH ODS Scores at Week 12
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.01
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 % Change in PIH ODS Scores at Week 16
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4039
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 % Change in PIH ODS Scores at Week 20
    Comparison groups
    Trifarotene Cream v Trifarotene Vehicle Cream
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4039
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening up to Week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Trifarotene Cream
    Reporting group description
    		 Subjects applied Trifarotene 50 (mcg/g) cream on face once daily in the evening for 24 weeks.

    Reporting group title
    Trifarotene Vehicle Cream
    Reporting group description
    		 Subjects applied Trifarotene vehicle cream on face once daily in the evening for 24 weeks.

    Serious adverse events
    		 Trifarotene Cream Trifarotene Vehicle Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Bipolar Disorder
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Trifarotene Cream Trifarotene Vehicle Cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 60 (16.67%)
    19 / 63 (30.16%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hair follicle tumour benign
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Application site burn
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Bipolar I disorder
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bacterial vaginosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    3 / 60 (5.00%)
    6 / 63 (9.52%)
         occurrences all number
    3
    6
    Ear infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Vaginal infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1

    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
    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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