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    Clinical Trial Results:
    Efficacy and safety of CD5024 1% in acne vulgaris

    Summary
    EudraCT number
    2016-000063-16
    Trial protocol
    DE  
    Global end of trial date
    02 Nov 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Oct 2020
    First version publication date
    21 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.109807
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03034460
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Galderma R&D SNC
    Sponsor organisation address
    Les Templiers, 2400 route des Colles, Biot, France, 06410
    Public contact
    CTA Coordinator, Galderma R&D SNC, +33 493-95-70-85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, Galderma R&D SNC, +33 493-95-70-85, cta.coordinator@galderma.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
    02 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of CD5024 1 percent (%) cream applied once daily over a 6-week treatment period compared to its vehicle in adult subjects suffering from acne vulgaris.
    Protection of trial subjects
    This clinical trial was conducted in accordance with the protocol, the Helsinki declaration (1964) and subsequent amendments, and the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and in compliance with applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Apr 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
    Canada: 15
    Country: Number of subjects enrolled
    France: 35
    Country: Number of subjects enrolled
    Germany: 20
    Worldwide total number of subjects
    70
    EEA total number of subjects
    55
    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)
    0
    Adults (18-64 years)
    70
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at six centers in three countries (Germany, France, Canada) between 25 April 2016 (first subject screened) to 02 November 2016 (last subject completed).

    Pre-assignment
    Screening details
    A total of 70 subjects were randomized in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group I: CD5024 Cream Versus its Vehicle
    Arm description
    Subjects applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
    Arm type
    Experimental

    Investigational medicinal product name
    CD5024 1% cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    CD5024 1% cream was applied once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6 of treatment period.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    CD5024 1% cream matched placebo was applied once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6 of treatment period.

    Arm title
    Group II: Epiduo Gel Versus its Vehicle
    Arm description
    Subjects applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adapalene Benzoyl Peroxyde
    Investigational medicinal product code
    Other name
    Epiduo
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Adapalene benzoyl peroxyde gel was applied once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6 of treatment period.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Epiduo Gel matched placebo was applied once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6, for a total of 29 applications.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The study was considered to be an investigator-blinded study design.
    Number of subjects in period 1
    Group I: CD5024 Cream Versus its Vehicle Group II: Epiduo Gel Versus its Vehicle
    Started
    48
    22
    Completed
    45
    19
    Not completed
    3
    3
         Subject discontinued due to “personal reasons”
    1
    -
         Adverse event, non-fatal
    -
    1
         Consent withdrawn by subject
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group I: CD5024 Cream Versus its Vehicle
    Reporting group description
    Subjects applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.

    Reporting group title
    Group II: Epiduo Gel Versus its Vehicle
    Reporting group description
    Subjects applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.

    Reporting group values
    Group I: CD5024 Cream Versus its Vehicle Group II: Epiduo Gel Versus its Vehicle Total
    Number of subjects
    48 22 70
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    23.3 ± 4.7 23.4 ± 4.4 -
    Gender categorical
    Units: Subjects
        Female
    34 14 48
        Male
    14 8 22
    Race (NIH/OMB)
    Units: Subjects
        White
    46 14 60
        Black or African American
    2 4 6
        Unknown or not reported
    0 2 2
        Asian
    0 2 2
    Number of inflammatory lesions
    Inflammatory lesion counts corresponded to the sum of papules and pustules.
    Units: Lesion Count
        arithmetic mean (standard deviation)
    34.0 ± 11.6 34.2 ± 15.1 -

    End points

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    End points reporting groups
    Reporting group title
    Group I: CD5024 Cream Versus its Vehicle
    Reporting group description
    Subjects applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.

    Reporting group title
    Group II: Epiduo Gel Versus its Vehicle
    Reporting group description
    Subjects applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.

    Subject analysis set title
    CD5024 1% Cream
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.

    Subject analysis set title
    CD5024 1% Cream Matched Placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.

    Subject analysis set title
    Adapalene Benzoyl Peroxyde
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.

    Subject analysis set title
    Adapalene Benzoyl Peroxyde Matched Placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.

    Primary: Inflammatory Lesion Count (Papules and Pustules) at Day 40

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    End point title
    Inflammatory Lesion Count (Papules and Pustules) at Day 40
    End point description
    Inflammatory lesion count corresponded to the sum of papules and pustules. This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all subjects who were randomized. Endpoint data was summarized using the LOCF at Day 40.
    End point type
    Primary
    End point timeframe
    Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: lesion count
        arithmetic mean (standard deviation)
    10.1 ± 5.8
    8.9 ± 5.0
    6.1 ± 4.9
    9.4 ± 5.7
    Statistical analysis title
    CD5024 Cream Versus its Vehicle
    Statistical analysis description
    This analysis was performed for paired difference between Active - Vehicle (CD5024 1% Cream Matched Placebo [subjects (n)=48] versus CD5024 1% Cream [n=48]).
    Comparison groups
    CD5024 1% Cream Matched Placebo v CD5024 1% Cream
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.158
    Method
    Wilcoxon rank signed test
    Confidence interval
    Statistical analysis title
    Epiduo Gel Versus its Vehicle
    Statistical analysis description
    This analysis was performed for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde [n=22] versus Adapalene Benzoyl Peroxyde Matched Placebo [22]).
    Comparison groups
    Adapalene Benzoyl Peroxyde v Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Wilcoxon rank signed test
    Confidence interval

    Secondary: Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)

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    End point title
    Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
    End point description
    Inflammatory lesion count corresponded to the sum of papules and pustules. This analysis was performed on ITT population. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: lesion count
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    16.5 ± 4.9
    17.5 ± 7.4
    17.6 ± 8.6
    16.6 ± 7.2
    No statistical analyses for this end point

    Secondary: Percent Reduction from Baseline (Day 1) in Inflammatory Lesion Count at Day 40

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    End point title
    Percent Reduction from Baseline (Day 1) in Inflammatory Lesion Count at Day 40
    End point description
    Inflammatory lesion count corresponded to the sum of papules and pustules. This analysis was performed on ITT population. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: percent reduction of lesion count
        arithmetic mean (standard deviation)
    35.7 ± 43.4
    44.4 ± 32.3
    65.5 ± 24.0
    42.5 ± 30.1
    No statistical analyses for this end point

    Secondary: Total Lesion Count at Baseline (Day 1) and Day 40

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    End point title
    Total Lesion Count at Baseline (Day 1) and Day 40
    End point description
    Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT population included all subjects who were randomized. Endpoint data was summarized using the LOCF at Day 40.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: lesion count
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    37.7 ± 11.2
    39.4 ± 13.7
    37.3 ± 20.2
    36.4 ± 18.0
        Day 40
    26.4 ± 16.8
    25.9 ± 14.3
    19.3 ± 15.0
    25.5 ± 17.2
    No statistical analyses for this end point

    Secondary: Percent Reduction from Baseline (Day 1) in Total Lesions at Day 40

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    End point title
    Percent Reduction from Baseline (Day 1) in Total Lesions at Day 40
    End point description
    Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. This analysis was performed on ITT population. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: percent reduction in total lesion count
    arithmetic mean (standard deviation)
        Day 40
    32.5 ± 32.2
    34.0 ± 27.1
    50.2 ± 27.2
    27.8 ± 31.8
    No statistical analyses for this end point

    Secondary: Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40

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    End point title
    Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
    End point description
    Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. This analysis was performed on ITT population. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: lesion count
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    21.1 ± 9.5
    21.8 ± 10.7
    19.6 ± 14.1
    19.6 ± 13.6
        Day 40
    16.2 ± 13.1
    16.9 ± 12.7
    13.0 ± 12.0
    16.0 ± 14.1
    No statistical analyses for this end point

    Secondary: Percent Reduction from Baseline in Non-Inflammatory Lesion at Day 40

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    End point title
    Percent Reduction from Baseline in Non-Inflammatory Lesion at Day 40
    End point description
    Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. This analysis was performed on ITT population. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Day 40
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: percent reduction of lesion count
    arithmetic mean (standard deviation)
        Day 40
    27.8 ± 39.4
    21.3 ± 42.0
    36.9 ± 36.1
    11.7 ± 48.6
    No statistical analyses for this end point

    Secondary: Number of Subjects Reported for Investigator’s Preference on a 5-Point Scale at Day 40

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    End point title
    Number of Subjects Reported for Investigator’s Preference on a 5-Point Scale at Day 40
    End point description
    The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side. This analysis was performed on ITT population. ITT population included all subjects who were randomized. Here ‘N’ (number of subjects analyzed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 40
    End point values
    Group I: CD5024 Cream Versus its Vehicle Group II: Epiduo Gel Versus its Vehicle
    Number of subjects analysed
    47
    21
    Units: number of subjects
        Day 40 (Active much better than Vehicle)
    0
    4
        Day 40 (Active better than Vehicle)
    16
    7
        Day 40 (No clinical difference between A and V)
    16
    6
        Day 40 (Vehicle better than Active)
    14
    4
        Day 40 (Vehicle much better than Active)
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reported for Subject's Preference on 5-Point Scale at Day 40

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    End point title
    Number of Subjects Reported for Subject's Preference on 5-Point Scale at Day 40
    End point description
    The subjects gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side. This analysis was performed on ITT population. ITT population included all subjects who were randomized. Here ‘N’ (number of subjects analyzed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 40
    End point values
    Group I: CD5024 Cream Versus its Vehicle Group II: Epiduo Gel Versus its Vehicle
    Number of subjects analysed
    47
    21
    Units: number of subjects
        Day 40 (Active much better than Vehicle)
    2
    2
        Day 40 (Active better than Vehicle)
    11
    11
        Day 40 (No clinical difference between A and V)
    15
    4
        Day 40 (Vehicle better than Active)
    16
    3
        Day 40 (Vehicle much better than Active)
    3
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs)

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    End point title
    Number of Subjects With Adverse Events (AEs)
    End point description
    AE was any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. This analysis was performed on safety population. Safety population included subjects in the ITT population who received at least 1 application of the investigational product. Number of subjects with AE's were reported.
    End point type
    Secondary
    End point timeframe
    From start of study up to follow up (Week 7)
    End point values
    Group I: CD5024 Cream Versus its Vehicle Group II: Epiduo Gel Versus its Vehicle
    Number of subjects analysed
    48
    22
    Units: number of subjects
    32
    14
    No statistical analyses for this end point

    Secondary: Number of Subjects Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)

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    End point title
    Number of Subjects Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
    End point description
    Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Safety population included subjects in the ITT population who received at least 1 application of the investigational product. Number of subjects reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported. Here 'n' (number analyzed) signifies number of subjects who were evaluable for each specified category.
    End point type
    Secondary
    End point timeframe
    From Day 1 up Follow up (Week 7)
    End point values
    CD5024 1% Cream CD5024 1% Cream Matched Placebo Adapalene Benzoyl Peroxyde Adapalene Benzoyl Peroxyde Matched Placebo
    Number of subjects analysed
    48
    48
    22
    22
    Units: number of subjects
        Face: Erythema: 0-None (n=48,48,22,22)
    37
    38
    8
    15
        Face: Erythema: 1-Mild (n=48,48,22,22)
    9
    9
    11
    6
        Face: Erythema: 2-Moderate (n=48,48,22,22)
    2
    1
    3
    1
        Face: Scaling/Desquamation: 0-None (n=48,48,22,22)
    38
    38
    5
    16
        Face: Scaling/Desquamation: 1-Mild (n=48,48,22,22)
    10
    10
    13
    5
        Face: Scaling/Desquamation: 2-Moderate (n=48,48,22
    0
    0
    4
    1
        Face: Dryness: 0-None (n=48,48,22,22)
    38
    37
    4
    10
        Face: Dryness: 1-Mild (n=48,48,22,22)
    10
    11
    13
    12
        Face: Dryness: 2-Moderate (n=48,48,22,22)
    0
    0
    5
    0
        Face: Stinging/Burning: 0-None (n=48,48,22,22)
    44
    43
    8
    17
        Face: Stinging/Burning: 1-Mild (n=48,48,22,22)
    3
    4
    8
    5
        Face: Stinging/Burning: 2-Moderate (n=48,48,22,22)
    1
    1
    6
    0
        Ear: Erythema: 0-None (n=22,22,11,11)
    20
    20
    8
    11
        Ear: Erythema: 1-Mild (n=22,22,11,11)
    2
    2
    2
    0
        Ear: Erythema: 2-Moderate (n=22,22,11,11)
    0
    0
    1
    0
        Ear: Scaling/Desquamation: 0-None (n=22,22,11,11)
    22
    22
    7
    11
        Ear: Scaling/Desquamation: 1-Mild (n=22,22,11,11)
    0
    0
    3
    0
        Ear: Scaling/Desquamation: 2-Moderate (n=22,22,11,
    0
    0
    1
    0
        Ear: Dryness: 0-None (n=22,22,11,11)
    22
    22
    7
    10
        Ear: Dryness: 1-Mild (n=22,22,11,11)
    0
    0
    3
    1
        Ear: Dryness: 2-Moderate (n=22,22,11,11)
    0
    0
    1
    0
        Ear: Stinging/Burning: 0-None (n=22,22,11,11)
    22
    22
    8
    11
        Ear: Stinging/Burning: 1-Mild (n=22,22,11,11)
    0
    0
    2
    0
        Ear: Stinging/Burning: 2-Moderate (n=22,22,11,11)
    0
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study up to follow up (Week 7)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Group I
    Reporting group description
    Subjects applied 500 mcL of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.

    Reporting group title
    Group II
    Reporting group description
    Subjects applied 500 mcL of Adapalene Benzoyl Peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.

    Serious adverse events
    Group I Group II
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (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: 5%
    Non-serious adverse events
    Group I Group II
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 48 (66.67%)
    11 / 22 (50.00%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 48 (27.08%)
    5 / 22 (22.73%)
         occurrences all number
    13
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 48 (29.17%)
    4 / 22 (18.18%)
         occurrences all number
    14
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Sep 2016
    Amendment 1: - Modified the primary efficacy endpoint to evaluate only inflammatory acne lesion count at Day 40 per half face and not percent reduction - Changed “inflammatory lesion count and percent reduction per half face (at each evaluation visit)” from primary to secondary efficacy criteria - Created a last visit for treatment period (Endpoint), which contained the last observation carried forward (LOCF). The ITT population was to be analyzed for efficacy only at Baseline and at Day 40 (Endpoint/LOCF) - Added that all safety data would be summarized based on the Safety population - Revised the description of inferential statistical analyses to: This is an exploratory Phase 2a study used to inform sponsor for an internal go/no decision. Primary endpoint is inflammatory acne lesion count at Day 40 per half face on ITT-LOCF population. Significance would be declared for 2-sided tests when the p-value did not exceed 0.05 - The others endpoints were exploratory. P-values were to be given for indicative purpose so no adjustment was to be made -Changed confidence interval from 90% to 95% - Corrected country code for study numbers of studies used for historical data with respect to sample size determination

    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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