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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) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects with Facial Acne Vulgaris

    Summary
    EudraCT number
    		 2023-000463-32
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2023
    First version publication date
    27 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CB-03-01/25
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02608450
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cassiopea SpA
    Sponsor organisation address
    Via C. Colombo 1, Linate, Italy, 20045
    Public contact
    Cassiopea SpA, Cosmo SpA, +39 02868 91124, dermatology@cosmopharma.com
    Scientific contact
    Cassiopea SpA, Cosmo SpA, +39 02868 91124, dermatology@cosmopharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003330-PIP01-22
    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
    17 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 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
    The study protocol, consent/assent form, participant recruitment materials/process, and other relevant documents were submitted for review and approval prior to study initiation to a central or local Institutional Review Board (IRB) for all US sites, and to an Independent Ethics Committee (IEC) for Republic of Georgia sites and to a Local Ethics Committee (LEC) for Ukraine sites. The IRB approval complied with the requirements set forth in Title 21 of the Code of Federal Regulations (CFR), Parts 56.107 to 56.115. The approval of the consent/assent in Republic of Georgia and Ukraine complied with local legislation and international standards. The study was conducted in accordance with principles of the Declaration of Helsinki, with the current Good Clinical Practice (GCP) Guideline and with other applicable regulations.
    Background therapy
    		 No background therapy was planned
    Evidence for comparator
    		 No comparators were used in the study
    Actual start date of recruitment
    21 Jan 2016
    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
    United States: 502
    Country: Number of subjects enrolled
    Georgia: 74
    Country: Number of subjects enrolled
    Ukraine: 132
    Worldwide total number of subjects
    708
    EEA total number of subjects
    0
    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)
    16
    Adolescents (12-17 years)
    300
    Adults (18-64 years)
    392
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There were 825 subjects screened for this study; 708 subjects were enrolled, and 117 subjects were screen failures. Of the 708 enrolled subjects, 353 subjects were randomized to treatment with CB-03-01 and 355 subjects were randomized to treatment with Vehicle.

    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, Monitor
    Blinding implementation details
    Subjects who are eligible for enrollment into the study will be randomized to receive CB-03-01 cream or vehicle cream in a 1:1 ratio. The system automatically assigned the lowest available study drug kit number available at the site containing the treatment to which the subject was randomized. Treatment group designation remained blinded until the final database was locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CB-03-01 Cream
    Arm description
    		 CB-03-01 cream, 1% applied twice daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    CB-03-01 Cream, 1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Twice daily application of CB-03-01 Cream, 1% (about 1 gram) for 12 weeks.

    Arm title
    		 Vehicle Cream
    Arm description
    		 Vehicle cream applied twice daily for 12 weeks
    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
    Twice daily application of Vehicle Cream (about 1 gram) for 12 weeks

    Number of subjects in period 1
    		CB-03-01 Cream Vehicle Cream
    Started
    353
    355
    Completed
    287
    290
    Not completed
    66
    65
         Withdrawal by parent
    2
    3
         Consent withdrawn by subject
    21
    15
         Physician decision
    -
    1
         Adverse event, non-fatal
    3
    6
         Pregnancy
    -
    1
         Noncompliance with study drug
    -
    2
         Lost to follow-up
    39
    32
         Progressive disease
    1
    -
         Multiple reasons
    -
    2
         Lack of efficacy
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CB-03-01 Cream
    Reporting group description
    		 CB-03-01 cream, 1% applied twice daily for 12 weeks

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Vehicle cream applied twice daily for 12 weeks

    Reporting group values
    		 CB-03-01 Cream Vehicle Cream Total
    Number of subjects
    		 353 355 708
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 20.0 ( 6.7 ) 19.9 ( 6.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 221 215 436
        Male
    		 132 140 272
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 94 80 174
        Not Hispanic or Latino
    		 259 275 534
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 9 10 19
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        Black or African American
    		 31 38 69
        White
    		 298 297 595
        More than one race
    		 9 7 16
        Not recorded
    		 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
    		 292 291 583
        4 - Severe
    		 61 64 125
    Baseline Acne Lesions Counts
    Non-inflammatory Lesions
    Units: Lesions
        arithmetic mean (standard deviation)
    		 59.1 ( 22.2 ) 60.7 ( 22.1 ) -
    Baseline Acne Lesion Counts
    Inflammatory Lesions
    Units: Lesions
        arithmetic mean (standard deviation)
    		 42.4 ( 11.8 ) 42.9 ( 12.3 ) -
    Baseline Acne Lesion Counts
    Total Lesions
    Units: Lesions
        arithmetic mean (standard deviation)
    		 101.5 ( 25.1 ) 103.6 ( 26.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    CB-03-01 Cream
    Reporting group description
    		 CB-03-01 cream, 1% applied twice daily for 12 weeks

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 Vehicle cream applied twice daily for 12 weeks

    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
    Percentage of subjects in each treatment group achieving "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
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: % of participants
        number (not applicable)
    18.4
    9.0
    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 achieving success in each treatment group at Week 12, where "success" was defined as an IGA score of "clear (score=O)" or "almost clear (score=1)" AND at least a two-point improvement in IGA compared to Baseline.
    Comparison groups
    CB-03-01 Cream v Vehicle Cream
    Number of subjects included in analysis
    708
    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)

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    End point title
    		 Absolute Change From Baseline in Non-inflammatory Lesion Count (NILC)
    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
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: Change from Baseline
        arithmetic mean (confidence interval 95%)
    -19.4 (-22.6 to -16.7)
    -13.0 (-15.7 to -10.3)
    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.
    Comparison groups
    Vehicle Cream v CB-03-01 Cream
    Number of subjects included in analysis
    708
    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)

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    End point title
    		 Absolute Change From Baseline in Inflammatory Lesion Count (ILC)
    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
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: Change from Baseline
        arithmetic mean (confidence interval 95%)
    -19.3 (-21.1 to -17.5)
    -15.5 (-17.3 to -13.6)
    Statistical analysis title
    		 Absolute change from baseline in ILC at week 12
    Statistical analysis description
    An ANCOVA 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.
    Comparison groups
    CB-03-01 Cream v Vehicle Cream
    Number of subjects included in analysis
    708
    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)

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    End point title
    		 Absolute Change From Baseline in Total Lesion Count (TLC)
    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
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: Total Lesions
        arithmetic mean (confidence interval 95%)
    -39.1 (-43.0 to -35.1)
    -28.8 (-32.6 to -24.9)
    Statistical analysis title
    		 Absolute Change from Baseline in TLC at week 12
    Statistical analysis description
    An ANCOVA 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.
    Comparison groups
    CB-03-01 Cream v Vehicle Cream
    Number of subjects included in analysis
    708
    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)

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    End point title
    		 Percent Change From Baseline in Total Lesion Count (TLC)
    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
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: Change from Baseline
        arithmetic mean (confidence interval 95%)
    -37.0 (-40.9 to -33.2)
    -28.4 (-32.3 to -24.6)
    Statistical analysis title
    		 Percent Change from Baseline in TLC at week 12
    Statistical analysis description
    An ANCOVA was used to compare the percent change from Baseline in TLC in each treatment group at Week 12, with treatment and analysis center as fixed effects and the Baseline TLC as the covariate.
    Comparison groups
    CB-03-01 Cream v Vehicle Cream
    Number of subjects included in analysis
    708
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent Change From Baseline in Non-inflammatory Lesion (NIL) Count

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    End point title
    		 Percent Change From Baseline in Non-inflammatory Lesion (NIL) Count
    End point description
    Percent change from Baseline in NIL count in each treatment group at Week 12.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: % Change from Baseline
        arithmetic mean (confidence interval 95%)
    -30.6 (-35.6 to -25.7)
    -21.6 (-26.4 to -16.8)
    Statistical analysis title
    		 Percent change from Baseline in NILC at week12
    Statistical analysis description
    An ANCOVA 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.
    Comparison groups
    CB-03-01 Cream v Vehicle Cream
    Number of subjects included in analysis
    708
    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
    		 CB-03-01 Cream Vehicle Cream
    Number of subjects analysed
    353
    355
    Units: % Change from Baseline
        arithmetic mean (confidence interval 95%)
    -44.8 (-49.0 to -40.5)
    -36.5 (-40.8 to -32.2)
    Statistical analysis title
    		 Percent change from Baseline in ILC at week 12
    Statistical analysis description
    An ANCOVA 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.
    Comparison groups
    CB-03-01 Cream v Vehicle Cream
    Number of subjects included in analysis
    708
    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
    The Safety population was used for all analyses which comprised of all participants enrolled in the study and applied at least one dose of the test article.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    CB-03-01 Cream
    Reporting group description
    		 -

    Reporting group title
    Vehicle Cream
    Reporting group description
    		 -

    Serious adverse events
    		 CB-03-01 Cream Vehicle Cream
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (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: 0.6%
    Non-serious adverse events
    		 CB-03-01 Cream Vehicle Cream
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 353 (2.55%)
    18 / 355 (5.07%)
    Injury, poisoning and procedural complications
    Application site pruritus
         subjects affected / exposed
    2 / 353 (0.57%)
    3 / 355 (0.85%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 353 (0.28%)
    3 / 355 (0.85%)
         occurrences all number
    1
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 353 (1.70%)
    12 / 355 (3.38%)
         occurrences all number
    7
    12

    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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    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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