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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects with Facial Acne Vulgaris

    Summary
    EudraCT number
    		 2023-000461-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Feb 2014

    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
    171-7151-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01631474
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Intrepid Therapeutics Inc.
    Sponsor organisation address
    12463 Rancho Bernardo Road, #537, San Diego, United States, CA 92128-2143
    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
    21 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the safety and efficacy of topical creams containing 0.1% (BID), 0.5% (BID) or 1% (QD and BID) CB-03-01 and the vehicle cream (QD or BID) in subjects with facial acne vulgaris.
    Protection of trial subjects
    Approval on the conduct of the trial was obtained by an IRB and by the FDA prior to study initiation. The study protocol, consent/assent form, participant recruitment materials/process, and other relevant documents were submitted for approval 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 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 studyu
    Actual start date of recruitment
    11 Jun 2012
    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: 363
    Worldwide total number of subjects
    363
    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)
    0
    Adolescents (12-17 years)
    165
    Adults (18-64 years)
    198
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 505 subjects were screened for the study; 363 subjects (72: CB-03-01 0.1% BID; 76: CB-03-01 0.5% BID; 70: CB-03-01 1% QD; 70 CB-03-01 1% BID; and 75: vehicle QD or BID) were enrolled into the study; 142 subjects were screen failures.

    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
    		 Low-dose Active, BID
    Arm description
    		 Low dose of CB-03-01, 0.1% topical cream applied twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    CB-03-01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    0.1% applied twice a day

    Arm title
    		 Medium-dose Active, BID
    Arm description
    		 Medium dose of CB-03-01, 0.5% topical cream applied twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    CB-03-01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    0.5% applied twice a day

    Arm title
    		 High-dose Active, QD
    Arm description
    		 High dose of CB-03-01, 1% topical cream applied once a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    CB-03-01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    1% applied once a day

    Arm title
    		 High-dose Active, BID
    Arm description
    		 High dose of CB-03-01, 1% topical cream applied twice a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    CB-03-01
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    1% applied twice a day

    Arm title
    		 Vehicle, QD or BID
    Arm description
    		 Vehicle topical cream, applied once or twice a day
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical
    Dosage and administration details
    Topical cream applied once or twice a day

    Number of subjects in period 1
    		Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Started
    72
    76
    70
    70
    75
    Completed
    58
    64
    61
    59
    62
    Not completed
    14
    12
    9
    11
    13
         Consent withdrawn by subject
    4
    4
    2
    6
    5
         Adverse event, non-fatal
    -
    1
    -
    -
    -
         Noncompliance with study drug
    -
    -
    -
    -
    1
         Lost to follow-up
    8
    5
    7
    5
    5
         Lack of efficacy
    2
    2
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low-dose Active, BID
    Reporting group description
    		 Low dose of CB-03-01, 0.1% topical cream applied twice a day

    Reporting group title
    Medium-dose Active, BID
    Reporting group description
    		 Medium dose of CB-03-01, 0.5% topical cream applied twice a day

    Reporting group title
    High-dose Active, QD
    Reporting group description
    		 High dose of CB-03-01, 1% topical cream applied once a day

    Reporting group title
    High-dose Active, BID
    Reporting group description
    		 High dose of CB-03-01, 1% topical cream applied twice a day

    Reporting group title
    Vehicle, QD or BID
    Reporting group description
    		 Vehicle topical cream, applied once or twice a day

    Reporting group values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID Total
    Number of subjects
    		 72 76 70 70 75 363
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.8 ± 5.77 20.4 ± 6.31 18.3 ± 6.14 21.0 ± 6.22 19.2 ± 5.25 -
    Gender categorical
    Units: Subjects
        Female
    		 36 42 38 37 43 196
        Male
    		 36 34 32 33 32 167
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 22 20 6 15 13 76
        Not Hispanic or Latino
    		 50 56 64 55 62 287
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 0 2 0 3
        Asian
    		 1 3 4 4 4 16
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 0 1 2
        Black or African American
    		 12 14 16 20 12 74
        White
    		 58 54 50 42 53 257
        More than one race
    		 1 2 0 2 4 9
        Unknown or Not Reported
    		 0 1 0 0 1 2
    Baseline IGA Measure
    Units: Subjects
        0 - Clear
    		 0 0 0 0 0 0
        1 - Almost clear
    		 0 0 0 0 0 0
        2 - Mild
    		 10 6 15 18 11 60
        3 - Moderate
    		 56 62 44 32 53 247
        4 - Severe
    		 6 8 11 20 11 56
    Baseline lesions counts
    Units: Inflammatory Lesions
        arithmetic mean (full range (min-max))
    		 29.9 (20 to 74) 29.0 (20 to 74) 31.9 (20 to 72) 28.6 (20 to 63) 30.5 (20 to 75) -
    Subject analysis sets

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT Population. The ITT population included all subjects enrolled in the study who were randomized and dispensed test article.

    Subject analysis sets values
    		 ITT Population
    Number of subjects
    363
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    19.7 ± 5.99
    Gender categorical
    Units: Subjects
        Female
    196
        Male
    197
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    76
        Not Hispanic or Latino
    287
        Unknown or Not Reported
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    3
        Asian
    16
        Native Hawaiian or Other Pacific Islander
    2
        Black or African American
    74
        White
    257
        More than one race
    9
        Unknown or Not Reported
    2
    Baseline IGA Measure
    Units: Subjects
        0 - Clear
    0
        1 - Almost clear
    0
        2 - Mild
    60
        3 - Moderate
    247
        4 - Severe
    56
    Baseline lesions counts
    Units: Inflammatory Lesions
        arithmetic mean (full range (min-max))
    30.0 (20 to 75)

    End points

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    End points reporting groups
    Reporting group title
    Low-dose Active, BID
    Reporting group description
    		 Low dose of CB-03-01, 0.1% topical cream applied twice a day

    Reporting group title
    Medium-dose Active, BID
    Reporting group description
    		 Medium dose of CB-03-01, 0.5% topical cream applied twice a day

    Reporting group title
    High-dose Active, QD
    Reporting group description
    		 High dose of CB-03-01, 1% topical cream applied once a day

    Reporting group title
    High-dose Active, BID
    Reporting group description
    		 High dose of CB-03-01, 1% topical cream applied twice a day

    Reporting group title
    Vehicle, QD or BID
    Reporting group description
    		 Vehicle topical cream, applied once or twice a day

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT Population. The ITT population included all subjects enrolled in the study who were randomized and dispensed test article.

    Primary: Investigator's Global Assessment (IGA) "Success" - Week 12

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    End point title
    		 Investigator's Global Assessment (IGA) "Success" - Week 12
    End point description
    Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    72
    76
    70
    70
    75
    Units: Participants
    6
    3
    2
    6
    2
    Statistical analysis title
    		 Treatment Success Based on IGA at Week 12
    Statistical analysis description
    The treatment groups were compared with respect to the proportion of subjects with “treatment success” at Week 12/EOS using Fisher’s exact test. Treatment success was defined as a score of “clear” or “almost clear” (IGA score of 0 or 1) AND a two or more grade improvement from Baseline.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Fisher exact
    Confidence interval

    Primary: Inflammatory and Non-Inflammatory Lesion Counts - Week 12

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    End point title
    		 Inflammatory and Non-Inflammatory Lesion Counts - Week 12
    End point description
    Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    72
    76
    70
    70
    75
    Units: Lesions
    arithmetic mean (standard deviation)
        Inflammatory Lesions
    -7.3 ± 14.20
    -5.6 ± 11.26
    -7.9 ± 12.31
    -11.1 ± 14.07
    -8.3 ± 12.86
        Non-inflammatory Lesions
    -8.8 ± 17.38
    -6.3 ± 26.68
    -8.1 ± 20.47
    -15.8 ± 20.11
    -5.9 ± 18.47
    Statistical analysis title
    		 Absolute Change from Baseline in ILC at Week 12
    Statistical analysis description
    The absolute change from Baseline to Week 12/EOS in total inflammatory lesion counts was analyzed by rank analysis of covariance (ANCOVA) with the model including terms for treatment and study site with the Baseline total inflammatory lesion count serving as the covariate. Pairwise comparisons of the treatments were performed by rank ANCOVA.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Inflammatory and Non-Inflammatory Lesion Counts - Week 8

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    End point title
    		 Inflammatory and Non-Inflammatory Lesion Counts - Week 8
    End point description
    Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    59
    66
    66
    59
    63
    Units: Lesions
    arithmetic mean (standard deviation)
        Inflammatory Lesions
    -11.0 ± 10.49
    -7.1 ± 11.74
    -6.0 ± 16.50
    -11.9 ± 10.83
    -9.8 ± 13.09
        Non-inflammatory Lesions
    -7.5 ± 14.05
    -6.8 ± 15.85
    -4.3 ± 33.75
    -14.1 ± 18.21
    -8.0 ± 16.61
    Statistical analysis title
    		 Absolute Change in ILC/NILC at Week 8
    Statistical analysis description
    The absolute change from Baseline to Week 8 in total inflammatory/non-inflammatory lesion counts was analyzed by rank ANCOVA with the model including terms for treatment and study site with the Baseline total inflammatory/non-inflammatory lesion counts serving as the covariate. Pairwise comparisons of the treatments were performed by rank ANCOVA.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent Change in Lesion Counts - Week 8

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    End point title
    		 Percent Change in Lesion Counts - Week 8
    End point description
    Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Week 8
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    59
    66
    66
    59
    63
    Units: Percentage of Change
    arithmetic mean (standard deviation)
        Inflammatory Lesions
    -37.1 ± 34.40
    -26.5 ± 36.54
    -23.4 ± 44.47
    -43.1 ± 36.19
    -31.9 ± 36.42
        Non-Inflammatory Lesions
    -18.6 ± 34.35
    -20.3 ± 35.72
    -12.5 ± 53.54
    -33.3 ± 38.09
    -23.8 ± 42.11
    Statistical analysis title
    		 Percent Change in ILC/NILC at Week 8
    Statistical analysis description
    The treatment groups were compared with respect to the percent change in total inflammatory and non-inflammatory lesion counts at Week 8 using the Kruskal-Wallis test considering all treatments and pairwise comparisons of treatments.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Investigator's Global Assessment (IGA) "Success" - Week 8

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    End point title
    		 Investigator's Global Assessment (IGA) "Success" - Week 8
    End point description
    Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 8
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    59
    66
    66
    59
    63
    Units: Participants
    1
    3
    2
    4
    2
    Statistical analysis title
    		 Treatment Success Based on IGA at Week 8
    Statistical analysis description
    The treatment groups were compared with respect to the proportion of subjects with “treatment success”, as defined for the primary efficacy endpoint, at Week 8 using Fisher’s exact test.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Investigator's Global Assessment (IGA) "Clear" or "Almost Clear" - Week 4

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    End point title
    		 Investigator's Global Assessment (IGA) "Clear" or "Almost Clear" - Week 4
    End point description
    Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Week 4.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    62
    73
    66
    64
    70
    Units: Participants
        Week 4
    4
    2
    5
    7
    2
    Statistical analysis title
    		 “Clear” or “Almost Clear” Based on IGA - Week 4
    Statistical analysis description
    The treatment groups were compared with respect to the proportion of subjects scored as “clear” (IGA=0) or “almost clear” (IGA=1) at Week 4 using Fisher’s exact test. The Cochran-Armitage test for trend was used to assess if an increase in dose corresponded to an increase in “clear”/“almost clear” rates.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    335
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Investigator's Global Assessment (IGA) "Clear" or "Almost Clear" - Week 8

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    End point title
    		 Investigator's Global Assessment (IGA) "Clear" or "Almost Clear" - Week 8
    End point description
    Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Week 8.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    59
    66
    66
    59
    63
    Units: Participants
        Week 8
    3
    4
    4
    6
    4
    Statistical analysis title
    		 “Clear” or “Almost Clear” Based on IGA - Week 8
    Statistical analysis description
    The treatment groups were compared with respect to the proportion of subjects scored as “clear” (IGA=0) or “almost clear” (IGA=1) at Week 8 using Fisher’s exact test. The Cochran-Armitage test for trend was used to assess if an increase in dose corresponded to an increase in “clear”/“almost clear” rates.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Investigator's Global Assessment (IGA) "Clear" or "Almost Clear" - Week 12

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    End point title
    		 Investigator's Global Assessment (IGA) "Clear" or "Almost Clear" - Week 12
    End point description
    Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    72
    76
    70
    70
    75
    Units: Participants
        Week 12
    8
    4
    3
    9
    4
    Statistical analysis title
    		 “Clear” or “Almost Clear” Based on IGA - Week 12
    Statistical analysis description
    The treatment groups were compared with respect to the proportion of subjects scored as “clear” (IGA=0) or “almost clear” (IGA=1) at Week 12/EOS using Fisher’s exact test. The Cochran-Armitage test for trend was used to assess if an increase in dose corresponded to an increase in “clear”/“almost clear” rates.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percent Change in Lesion Counts - Week 12

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    End point title
    		 Percent Change in Lesion Counts - Week 12
    End point description
    Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Week 12
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Number of subjects analysed
    72
    76
    70
    70
    75
    Units: Percentage of Change
    arithmetic mean (standard deviation)
        Inflammatory Lesions
    -24.8 ± 49.72
    -21.0 ± 42.59
    -25.9 ± 36.68
    -37.2 ± 51.15
    -27.0 ± 39.97
        Non-Inflammatory Lesions
    -23.5 ± 36.46
    -17.3 ± 51.32
    -18.3 ± 39.36
    -32.9 ± 43.5
    -16.1 ± 45.61
    Statistical analysis title
    		 Percent Change in ILC/NILC at Week 12
    Statistical analysis description
    The treatment groups were compared with respect to the percent change in total inflammatory and non-inflammatory lesion counts at Week 12/EOS using the Kruskal-Wallis test considering all treatments and pairwise comparisons of treatments.
    Comparison groups
    Low-dose Active, BID v Medium-dose Active, BID v High-dose Active, QD v High-dose Active, BID v Vehicle, QD or BID
    Number of subjects included in analysis
    363
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Low-dose Active, BID
    Reporting group description
    		 Low dose of CB-03-01, 0.1% topical cream applied twice a day

    Reporting group title
    Medium-dose Active, BID
    Reporting group description
    		 Medium dose of CB-03-01, 0.5% topical cream applied twice a day

    Reporting group title
    High-dose Active, QD
    Reporting group description
    		 High dose of CB-03-01, 1% topical cream applied once a day

    Reporting group title
    High-dose Active, BID
    Reporting group description
    		 High dose of CB-03-01, 1% topical cream applied twice a day

    Reporting group title
    Vehicle, QD or BID
    Reporting group description
    		 Vehicle topical cream, applied once or twice a day

    Serious adverse events
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 76 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 75 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Low-dose Active, BID Medium-dose Active, BID High-dose Active, QD High-dose Active, BID Vehicle, QD or BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 72 (16.67%)
    18 / 76 (23.68%)
    9 / 70 (12.86%)
    5 / 70 (7.14%)
    5 / 75 (6.67%)
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    2 / 72 (2.78%)
    1 / 76 (1.32%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 75 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 72 (2.78%)
    1 / 76 (1.32%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    2
    1
    0
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 76 (2.63%)
    2 / 70 (2.86%)
    0 / 70 (0.00%)
    0 / 75 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 72 (1.39%)
    4 / 76 (5.26%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 75 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 76 (2.63%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    1 / 75 (1.33%)
         occurrences all number
    0
    2
    0
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 72 (8.33%)
    8 / 76 (10.53%)
    2 / 70 (2.86%)
    3 / 70 (4.29%)
    2 / 75 (2.67%)
         occurrences all number
    6
    8
    2
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 76 (0.00%)
    4 / 70 (5.71%)
    1 / 70 (1.43%)
    0 / 75 (0.00%)
         occurrences all number
    1
    0
    4
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Apr 2012
    Protocol Amendment #1
    09 May 2012
    Protocol Amendment #2
    12 Jun 2012
    Protocol Amendment #3
    26 Dec 2012
    Protocol Amendment #4

    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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