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    Clinical Trial Results:
    An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects with Acne Vulgaris

    Summary
    EudraCT number
    2023-000462-33
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Nov 2013

    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
    171-7151-202
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01831960
    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
    08 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to determine a) the adrenal suppression potential and b) the pharmacokinetic (PK) properties of CB-03-01 Cream, 1% in subjects with 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 study
    Actual start date of recruitment
    07 May 2013
    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: 42
    Worldwide total number of subjects
    42
    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)
    22
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    57 subjects were screened for the study; 42 subjects (20 adults in Cohort 1 and 22 adolescents in Cohort 2) were enrolled into the study; 15 subjects were screen failures.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cortexolone 17α-Propionate (Cohort 1)
    Arm description
    Cohort 1 enrolled adult subjects.
    Arm type
    Experimental

    Investigational medicinal product name
    Cortexolone 17α-Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Topical cream, 1.0% concentration, applied every twelve hours.

    Arm title
    Cortexolone 17α-Propionate (Cohort 2)
    Arm description
    Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Cortexolone 17α-Propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Topical cream, 1.0% concentration, applied every twelve hours.

    Number of subjects in period 1
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Started
    20
    22
    Completed
    20
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cortexolone 17α-Propionate (Cohort 1)
    Reporting group description
    Cohort 1 enrolled adult subjects.

    Reporting group title
    Cortexolone 17α-Propionate (Cohort 2)
    Reporting group description
    Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age.

    Reporting group values
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2) Total
    Number of subjects
    20 22 42
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    24.4 ± 5.84 15.6 ± 1.33 -
    Gender categorical
    Units: Subjects
        Female
    15 12 27
        Male
    5 10 15
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 1 1
        Not Hispanic or Latino
    20 21 41
        Unknown or Not Reported
    0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    1 0 1
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    1 0 1
        White
    17 21 38
        More than one race
    1 1 2
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cortexolone 17α-Propionate (Cohort 1)
    Reporting group description
    Cohort 1 enrolled adult subjects.

    Reporting group title
    Cortexolone 17α-Propionate (Cohort 2)
    Reporting group description
    Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age.

    Primary: Change in HPA Axis Response to Cosyntropin

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    End point title
    Change in HPA Axis Response to Cosyntropin [1]
    End point description
    Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
    End point type
    Primary
    End point timeframe
    Baseline and Day 14
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All analyses were descriptive. Serum cortisol results were summarized for evaluable subjects. HPA axis responses to CST were dichotomized to normal and abnormal.
    End point values
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Number of subjects analysed
    20
    22
    Units: mcg/dL
    arithmetic mean (standard deviation)
        Baseline (pre-CST)
    17.0 ± 5.98
    16.8 ± 4.71
        Baseline (post-CST)
    27.7 ± 3.43
    24.6 ± 3.12
        Day 14 (pre-CST)
    18.1 ± 7.02
    15.4 ± 3.98
        Day 14 (post-CST)
    26.7 ± 5.56
    22.8 ± 2.99
    No statistical analyses for this end point

    Primary: PK Profiles (Cmax) of Cortexolone 17α-propionate

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    End point title
    PK Profiles (Cmax) of Cortexolone 17α-propionate [2]
    End point description
    Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).
    End point type
    Primary
    End point timeframe
    Baseline and Day 14
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All analyses were descriptive and of exploratory nature. If p-values or confidence intervals (CI) were presented, they were to be interpreted descriptively. Non-compartmental analysis was used for estimation of PK parameters.
    End point values
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Number of subjects analysed
    20
    22
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax - Day 1 (ng/mL)
    3.23 ± 2.01
    3.58 ± 4.30
        Cmax - Day 14 (ng/mL)
    4.46 ± 3.00
    4.61 ± 4.74
    No statistical analyses for this end point

    Primary: PK Profiles (AUC) of Cortexolone 17α-propionate

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    End point title
    PK Profiles (AUC) of Cortexolone 17α-propionate [3]
    End point description
    Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application [0-12 hours]) and at Day 14 (i.e., Day 14, after last application [0-12 hours]).
    End point type
    Primary
    End point timeframe
    Baseline and Day 14
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All analyses were descriptive and of exploratory nature. If p-values or confidence intervals (CI) were presented, they were to be interpreted descriptively. Non-compartmental analysis was used for estimation of PK parameters.
    End point values
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Number of subjects analysed
    20
    22
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        AUCτ - Day 1
    22.02 ± 13.67
    22.55 ± 22.57
        AUCτ - Day 14
    37.14 ± 22.92
    30.97 ± 24.65
    No statistical analyses for this end point

    Primary: PK Profiles (Cavg) of Cortexolone 17α-propionate

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    End point title
    PK Profiles (Cavg) of Cortexolone 17α-propionate [4]
    End point description
    Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).
    End point type
    Primary
    End point timeframe
    Baseline and Day 14
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All analyses were descriptive and of exploratory nature. If p-values or confidence intervals (CI) were presented, they were to be interpreted descriptively. Non-compartmental analysis was used for estimation of PK parameters.
    End point values
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Number of subjects analysed
    20
    22
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cavg - Day 1
    1.84 ± 1.14
    1.88 ± 1.88
        Cavg - Day 14
    3.10 ± 1.91
    2.58 ± 2.05
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 days
    Adverse event reporting additional description
    Any treatment emergent AEs ongoing at the end of the treatment period (Day 14) were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Cortexolone 17α-Propionate (Cohort 1)
    Reporting group description
    -

    Reporting group title
    Cortexolone 17α-Propionate (Cohort 2)
    Reporting group description
    -

    Serious adverse events
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cortexolone 17α-Propionate (Cohort 1) Cortexolone 17α-Propionate (Cohort 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 20 (25.00%)
    3 / 22 (13.64%)
    Investigations
    ACTH stimulation test abnormal
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Application site folliculitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2013
    Protocol Amendment #1
    11 Jun 2013
    Protocol Amendment #2

    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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