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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) 1% Cream Applied Twice-Daily for 12 Weeks in Subjects with Facial Acne Vulgaris

    Summary
    EudraCT number
    		 2015-002623-26
    Trial protocol
    		 BG   RO  
    Global end of trial date
    21 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2020
    First version publication date
    27 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CB-03-01/26
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02608476
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cassiopea SpA
    Sponsor organisation address
    Via C. Colombo 1 , Linate , Italy,
    Public contact
    Cassiopea Research & Development, Cassiopea SpA, +39 02868 91 124, R&D@cassiopea.com
    Scientific contact
    Cassiopea Research & Development, Cassiopea SpA, +39 02868 91 124, R&D@cassiopea.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
    03 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.
    Protection of trial subjects
    Approval on the conduct of the trial was obtained by the national Ethic Committee, by the central IRB or by the IEC of each participating center and by the relevant Competent Authorities (CAs). Subject selection or any other study-related procedures did not commence until approval from both involved CAs and IECs according to the local regulations of the involved countries had been obtained. The study protocol, the subject information leaflet and the informed consent/assent document were submitted to the national Independent Ethics Committee (IEC) of Bulgaria, Romania and Poland and to the IEC of each center participating in the study in Serbia and Republic of Georgia. For all US sites, the study protocol, consent/assent form, participant recruitment materials/process, and other relevant documents were submitted to a central IRB and approval obtained in compliance with the requirements set forth in Title 21 of the Code of Federal Regulations (CFR), Parts 56.107 to 56.115 The study was conducted under the provisions of the Declaration of Helsinki, (64th WMA General Assembly, Fortaleza, Brazil, October 2013 for EU and 7th revision for US), and in accordance with the International Conference on Harmonization (ICH) Consolidated Guideline on Good Clinical Practice (GCP) (EMA/CHMP/ICH/135/1995 E6(R1) of July 2002 and E6(R2) of December 2016) and with other applicable regulations Male and female subjects 9 years of age or older with moderate to severe facial acne vulgaris (Grade 3 or 4 on Investigator’s Global Assessment [IGA]) were recruited as subjects from study centers in Bulgaria, Republic of Georgia, Poland, Romania, Serbia and US. Interested individuals were given an opportunity to discuss the activities involved in study participation with the site staff and the principal investigator. An IRB- or IEC-approved informed consent/assent form and subject instruction sheet were given to the potential subject and an opportunity afforded to read the consent/assent fo
    Background therapy
    		 no background therapy was planned
    Evidence for comparator
    		 no comparator were used in the study
    Actual start date of recruitment
    16 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
    Poland: 222
    Country: Number of subjects enrolled
    Romania: 186
    Country: Number of subjects enrolled
    Bulgaria: 90
    Country: Number of subjects enrolled
    Georgia: 102
    Country: Number of subjects enrolled
    United States: 93
    Country: Number of subjects enrolled
    Serbia: 39
    Worldwide total number of subjects
    732
    EEA total number of subjects
    498
    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)
    3
    Adolescents (12-17 years)
    341
    Adults (18-64 years)
    388
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients recruited by investigators in their research sites from the database or by means of website advertisement or reference from other doctors. Patients underwent screening procedures and were required to meet all the inclusion criteria and none of the exclusion criteria.

    Pre-assignment
    Screening details
    		 A total of 756 subjects were screened and 732 of them were randomized to the assigned treatment, whereas 24 subjects were screening failures: 369 subjects were randomised to receive CB-03-01 and 363 were randomised to receive vehicle

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Subjects who were eligible for enrollment into the study were randomized to receive CB-03-01 cream or vehicle cream in a 1:1 ratio The randomization scheme was blocked by investigational site. At each site, subject kits were dispensed according to the kit number assigned by an Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS) as subjects were enrolled

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 clascoterone cream 1%
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clascoterone cream 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The twice daily application of clascoterone Cream 1% ( 1gr each application) for 12 weeks Cream was applied in the morning and in the evening 30 minutes before to go to bed .

    Arm title
    		 Vehicle
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    About 1 gram of the cream was applied to the face twice daily (in the morning and in the evening).

    Number of subjects in period 1
    		clascoterone cream 1% Vehicle
    Started
    369
    363
    Completed
    302
    282
    Not completed
    67
    81
         Consent withdrawn by subject
    30
    37
         Physician decision
    1
    -
         Adverse event, non-fatal
    2
    8
         Consent withdrawn by parents/guardians
    5
    4
         Pregnancy
    -
    1
         had progressive disease
    1
    -
         poor compliance
    1
    5
         Lost to follow-up
    24
    24
         Lack of efficacy
    3
    1
         other reason
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    clascoterone cream 1%
    Reporting group description
    		 -

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Reporting group values
    		 clascoterone cream 1% Vehicle Total
    Number of subjects
    		 369 363 732
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.3 ± 5.6 19.0 ± 5.4 -
    Gender categorical
    Units: Subjects
        Female
    		 243 221 464
        Male
    		 126 142 268
    ethnicity
    Units: Subjects
        Hispanic or Latino
    		 20 9 29
        Not Hispanic or Latino
    		 349 354 703
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 2
        Asian
    		 0 4 4
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 7 6 13
        White
    		 357 348 705
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 4 2 6
    Baseline IGA
    Units: Subjects
        0-Clear
    		 0 0 0
        1-Almost clear
    		 0 0 0
        2-Mild
    		 0 0 0
        3-Moderate
    		 305 313 618
        4-Severe
    		 64 50 114
    Baseline Acne Lesion Count
    Not InFlammatory Lesion
    Units: Lesion
        arithmetic mean (standard deviation)
    		 62.8 ± 21.4 63.3 ± 20.5 -
    Baseline Acne Lesion Count
    Inflammatory Lesion
    Units: Lesion
        arithmetic mean (standard deviation)
    		 42.9 ± 12.2 41.3 ± 11.0 -
    Baseline Acne Lesion Count
    Total Lesion
    Units: Lesion
        arithmetic mean (standard deviation)
    		 105.7 ± 25.8 104.6 ± 24.2 -

    End points

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    End points reporting groups
    Reporting group title
    clascoterone cream 1%
    Reporting group description
    		 -

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Subject analysis set title
    Efficacy Analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to -treat ( ITT) set includes all randomized subjects

    Primary: Investigator’s Global Assessment (IGA) “Success” at week 12

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    End point title
    		 Investigator’s Global Assessment (IGA) “Success” at week 12
    End point description
    Proportion of subjects in each treatment group who achieved “success” at week 12, with “success” defined as an IGA score of “clear (score=0)” or “almost clear (score=1)” AND at least a two-point reduction in IGA compared to baseline.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: % IGA success
        number (not applicable)
    20.3
    6.5
    Statistical analysis title
    		 IGA “Success” at week 12
    Statistical analysis description
    A logistic regression model with treatment and analysis center as fixed effects was used to compare the proportion of subjects in each treatment group with at least a two-point reduction in IGA AND an IGA score of 0 (clear) or 1 (almost clear) at week 12. The adjusted odds ratio of the comparison between groups and its 95% confidence interval (CI) were derived from the regression model
    Comparison groups
    Vehicle v clascoterone cream 1%
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Logistic
    Confidence interval

    Primary: Absolute change from baseline in Non Inflammatory Lesion Count (NILC) at week 12

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    End point title
    		 Absolute change from baseline in Non Inflammatory Lesion Count (NILC) at week 12
    End point description
    Absolute change from baseline in NILC in each treatment group at week 12.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: change from baseline
        arithmetic mean (confidence interval 95%)
    -19.4 (-22.1 to -16.7)
    -10.8 (-13.6 to -8.0)
    Statistical analysis title
    		 Absolute change from baseline in NILC at week 12
    Statistical analysis description
    An analysis of covariance (ANCOVA) model was used to compare the absolute change from baseline in non-inflammatory lesion counts in each treatment group at week 12, with treatment and analysis center as fixed effects and the baseline non-inflammatory lesion counts as covariate. The adjusted means difference of the comparison between groups and its 95% CI were derived from the regression model.
    Comparison groups
    clascoterone cream 1% v Vehicle
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Primary: Absolute change from baseline in Inflammatory Lesion Count (ILC) at week 12

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    End point title
    		 Absolute change from baseline in Inflammatory Lesion Count (ILC) at week 12
    End point description
    Absolute change from baseline in ILC in each treatment group at week 12.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: change from baseline
        arithmetic mean (confidence interval 95%)
    -20.0 (-21.7 to -18.3)
    -12.6 (-14.3 to -10.8)
    Statistical analysis title
    		 Absolute change from baseline in ILC at week 12
    Statistical analysis description
    An ANCOVA model was used to compare the absolute change from baseline in inflammatory lesion counts in each treatment group at week 12, with treatment and analysis center as fixed effects and the baseline inflammatory lesion counts as covariate. The adjusted means difference of the comparison between groups and its 95% CI were derived from the regression model
    Comparison groups
    clascoterone cream 1% v Vehicle
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Absolute change from baseline in Total Lesion Count (TLC) at week 12.

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    End point title
    		 Absolute change from baseline in Total Lesion Count (TLC) at week 12.
    End point description
    Absolute change from baseline in TLC in each treatment group at week 12.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: change from baseline
        arithmetic mean (confidence interval 95%)
    -40.0 (-43.8 to -36.2)
    -23.6 (-27.8 to -19.5)
    Statistical analysis title
    		 Absolute change from baseline in TLC at week 12
    Statistical analysis description
    An ANCOVA model was used to compare the absolute change from baseline in total lesion counts in each treatment group at week 12, with treatment and analysis center as fixed effects and the baseline total lesion counts as covariate. The adjusted means difference of the comparison between groups and its 95% CI were derived from the regression model
    Comparison groups
    clascoterone cream 1% v Vehicle
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent change from baseline in Total Lesion Count (TLC) at week 12.

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    End point title
    		 Percent change from baseline in Total Lesion Count (TLC) at week 12.
    End point description
    Percent change from baseline in TLC in each treatment group at week 12.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: % change from baseline
        arithmetic mean (confidence interval 95%)
    -37.3 (-41.1 to -33.6)
    -22.1 (-26.1 to -18.1)
    Statistical analysis title
    		 Percent change in TLC at week12
    Statistical analysis description
    An ANCOVA model was used to compare the percent change from baseline in total lesion counts in each treatment group at week 12, with treatment and analysis center as fixed effects and the baseline total lesion counts as covariate. The adjusted means difference of the comparison between groups and its 95% CI were derived from the regression model
    Comparison groups
    clascoterone cream 1% v Vehicle
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent change from baseline in Non Inflammatory Lesion Count (NILC) at week 12.

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    End point title
    		 Percent change from baseline in Non Inflammatory Lesion Count (NILC) at week 12.
    End point description
    Percent change from baseline in NILC in each treatment group at week 12.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: % of Change from Baseline
        arithmetic mean (confidence interval 95%)
    -29.3 (-33.7 to -24.9)
    -15.6 (-20.3 to -10.9)
    Statistical analysis title
    		 Percent change from baseline in NILC at week12
    Statistical analysis description
    An ANCOVA model was used to compare the percentage change from baseline in noninflammatory lesion counts in each treatment group at week 12, with treatment and analysis center as fixed effects and the baseline non-inflammatory lesion counts as covariate. The adjusted means difference of the comparison between groups and its 95% CI were derived from the regression model
    Comparison groups
    clascoterone cream 1% v Vehicle
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent change from baseline in Inflammatory Lesion Count (ILC) at week 12.

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    End point title
    		 Percent change from baseline in Inflammatory Lesion Count (ILC) at week 12.
    End point description
    Percent change from baseline in ILC in each treatment group at week 12.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 clascoterone cream 1% Vehicle
    Number of subjects analysed
    369
    363
    Units: % of Change from Baseline
        arithmetic mean (confidence interval 95%)
    -46.9 (-50.9 to -42.8)
    -29.6 (-33.9 to -25.3)
    Statistical analysis title
    		 Percent change from baseline in ILC at week 12
    Statistical analysis description
    An ANCOVA model was used to compare the percentage change from baseline in inflammatory lesion counts in each treatment group at week 12, with treatment and analysis center as fixed effects and the baseline inflammatory lesion counts as covariate. The adjusted means difference of the comparison between groups and its 95% CI were derived from the regression model.
    Comparison groups
    clascoterone cream 1% v Vehicle
    Number of subjects included in analysis
    732
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination
    Adverse event reporting additional description
    Treatment-emergent AEs (TEAEs) are AEs collected from the date of the first dose of IMP until the date of the final study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    clascoterone 1% cream
    Reporting group description
    		 -

    Reporting group title
    vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 clascoterone 1% cream vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 363 (0.28%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    severe hematoma of the right thigh
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 363 (0.28%)
         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: 0.8%
    Non-serious adverse events
    		 clascoterone 1% cream vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 369 (5.69%)
    34 / 363 (9.37%)
    Nervous system disorders
    headache
         subjects affected / exposed
    4 / 369 (1.08%)
    3 / 363 (0.83%)
         occurrences all number
    4
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 369 (0.00%)
    3 / 363 (0.83%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 369 (0.54%)
    3 / 363 (0.83%)
         occurrences all number
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 369 (0.00%)
    3 / 363 (0.83%)
         occurrences all number
    0
    3
    Oropharingeal pain
         subjects affected / exposed
    4 / 369 (1.08%)
    4 / 363 (1.10%)
         occurrences all number
    4
    6
    Rhinorrhoea
         subjects affected / exposed
    3 / 369 (0.81%)
    5 / 363 (1.38%)
         occurrences all number
    3
    5
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 369 (0.27%)
    3 / 363 (0.83%)
         occurrences all number
    1
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 369 (0.81%)
    0 / 363 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 369 (0.81%)
    7 / 363 (1.93%)
         occurrences all number
    3
    10
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 369 (0.27%)
    4 / 363 (1.10%)
         occurrences all number
    1
    4

    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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