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    Clinical Trial Results:
    Multi-centre, randomized, double-blind, active- and vehiclecontrolled trial to compare the efficacy and safety of tretinoin clindamycin phosphate gel to clindamycin phosphate gel alone, tretinoin gel alone, and vehicle in the treatment of acne vulgaris in patients from 12 to less than 18 years of age.

    Summary
    EudraCT number
    2010-022918-15
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    21 Oct 2003

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    7001-G2HP-07-02
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dow Pharmaceutical Sciences
    Sponsor organisation address
    127 Hospital Drive, #202, Vallejo, United States, CA 94589
    Public contact
    Group leader study manager, Meda Pharma GmbH & Co. KG, +49 6172 888 01, 42b@medapharma.de
    Scientific contact
    Head of Corporate Clinical Affairs, Meda Pharma GmbH & Co. KG, +49 6172 888 01, 42b@medapharma.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000892-PIP01-10
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    28 Jan 2004
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2003
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2003
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy and safety of Clin-RA Gel to Clindamycin phosphate 1.2% Gel alone, Tretinoin 0.025% Gel alone, and Clin-RA Gel vehicle in the treatment of acne vulgaris.
    Protection of trial subjects
    No specific additional measures to minimise pain and distress were required. The subjects could withdraw from treatment at any time and for any reason.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Feb 2003
    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: 1288
    Worldwide total number of subjects
    1288
    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)
    2
    Adolescents (12-17 years)
    793
    Adults (18-64 years)
    493
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Male or female subjects of any race, 12 years of age or older, with acne vulgaris, presenting with 20-50 inflammatory lesions (papules and pustules), 20-100 non-inflammatory lesions (open and closed comedones), and < 2 nodules.

    Period 1
    Period 1 title
    overall trial (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
    Clin-RA
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Clindamycin phosphate 1.2% and Tretinoin 0.025%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Clin-RA Gel (Clindamycin phosphate 1.2% and Tretinoin 0.025%) Dosing: Once-a-day application (at bedtime) Mode of Administration: Topically applied to the face

    Arm title
    Clindamycin
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Clindamycin phosphate 1.2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Clindamycin phosphate 1.2% (in same vehicle as investigational product) Dosing: Once-a-day application (at bedtime) Mode of Administration: Topically applied to the face

    Arm title
    Tretinoin
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Tretinoin 0.025%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Tretinoin 0.025% (in same vehicle as investigational product) Dosing: Once-a-day application (at bedtime) Mode of Administration: Topically applied to the face

    Arm title
    Vehicle
    Arm description
    -
    Arm type
    Vehicle

    Investigational medicinal product name
    N/A (vehicle)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Dosing: Once-a-day application (at bedtime) Mode of Administration: Topically applied to the face

    Number of subjects in period 1
    Clin-RA Clindamycin Tretinoin Vehicle
    Started
    425
    218
    429
    216
    Completed
    352
    183
    347
    173
    Not completed
    73
    35
    82
    43
         Protocol deviation
    3
    -
    6
    1
         Other
    3
    2
    5
    3
         Lack of efficacy
    5
    2
    10
    7
         Inappropriate enrollment
    1
    1
    2
    2
         Pregnancy
    -
    -
    2
    -
         Adverse event, non-fatal
    5
    1
    3
    1
         Subject request
    27
    11
    21
    14
         Lost to follow-up
    29
    18
    33
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Clin-RA
    Reporting group description
    -

    Reporting group title
    Clindamycin
    Reporting group description
    -

    Reporting group title
    Tretinoin
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -

    Reporting group values
    Clin-RA Clindamycin Tretinoin Vehicle Total
    Number of subjects
    425 218 429 216 1288
    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)
    19.22 ± 8.01 19.25 ± 8.11 19.38 ± 8.14 19.04 ± 7.82 -
    Gender categorical
    Units: Subjects
        Female
    235 111 236 110 692
        Male
    190 107 193 106 596

    End points

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    End points reporting groups
    Reporting group title
    Clin-RA
    Reporting group description
    -

    Reporting group title
    Clindamycin
    Reporting group description
    -

    Reporting group title
    Tretinoin
    Reporting group description
    -

    Reporting group title
    Vehicle
    Reporting group description
    -

    Primary: Dichotomized Evaluator's Global Severity Score / Week 12

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    End point title
    Dichotomized Evaluator's Global Severity Score / Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    Clin-RA Clindamycin Tretinoin Vehicle
    Number of subjects analysed
    425
    218
    429
    216
    Units: Success, Failure
        Success
    95
    38
    60
    16
        Failure
    330
    180
    369
    200
    Statistical analysis title
    Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    643
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.122
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Tretinoin
    Comparison groups
    Clin-RA v Tretinoin
    Number of subjects included in analysis
    854
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Vehicle
    Comparison groups
    Clin-RA v Vehicle
    Number of subjects included in analysis
    641
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Primary: Percent Change from Baseline in Inflammatory Lesion Count / Week 12

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    End point title
    Percent Change from Baseline in Inflammatory Lesion Count / Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and week 12
    End point values
    Clin-RA Clindamycin Tretinoin Vehicle
    Number of subjects analysed
    425
    218
    429
    216
    Units: percent change
        median (full range (min-max))
    61.3 (-425 to 100)
    52.1 (-250 to 100)
    50 (-164 to 100)
    38.9 (-100 to 100)
    Statistical analysis title
    Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    643
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.02
    Method
    Ranked ANOVA
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Tretinoin
    Comparison groups
    Tretinoin v Clin-RA
    Number of subjects included in analysis
    854
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Ranked ANOVA
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Vehicle
    Comparison groups
    Clin-RA v Vehicle
    Number of subjects included in analysis
    641
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Ranked ANOVA
    Confidence interval

    Primary: Percent Change from Baseline in Non-inflammatory Lesion Count / Week 12

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    End point title
    Percent Change from Baseline in Non-inflammatory Lesion Count / Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and week 12.
    End point values
    Clin-RA Clindamycin Tretinoin Vehicle
    Number of subjects analysed
    425
    218
    429
    216
    Units: percent change
        median (full range (min-max))
    42.3 (-238 to 100)
    32.2 (-195 to 100)
    40 (-326 to 100)
    24.2 (-198 to 100)
    Statistical analysis title
    Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    643
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.088
    Method
    Ranked ANOVA
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Tretinoin
    Comparison groups
    Clin-RA v Tretinoin
    Number of subjects included in analysis
    854
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.11
    Method
    Ranked ANOVA
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Vehicle
    Comparison groups
    Clin-RA v Vehicle
    Number of subjects included in analysis
    641
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Ranked ANOVA
    Confidence interval

    Primary: Percent Change from Baseline in Total Lesion Count / Week 12

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    End point title
    Percent Change from Baseline in Total Lesion Count / Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and week 12.
    End point values
    Clin-RA Clindamycin Tretinoin Vehicle
    Number of subjects analysed
    425
    218
    429
    216
    Units: percent change
        median (full range (min-max))
    48.4 (-245 to 100)
    40.9 (-117 to 98)
    39.7 (-150 to 100)
    25 (-164 to 100)
    Statistical analysis title
    Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    643
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.018
    Method
    Ranked ANOVA
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Tretinoin
    Comparison groups
    Clin-RA v Tretinoin
    Number of subjects included in analysis
    854
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Ranked ANOVA
    Confidence interval
    Statistical analysis title
    Clin-RA vs. Vehicle
    Comparison groups
    Clin-RA v Vehicle
    Number of subjects included in analysis
    641
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Ranked ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    until 30 days post-treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    6.1
    Reporting groups
    Reporting group title
    Clin RA Gel
    Reporting group description
    Clindamycin phosphate 1.2% and Tretinoin 0.025%

    Reporting group title
    Tretinoin
    Reporting group description
    Tretinoin 0.025% (in same vehicle as investigational product)

    Reporting group title
    Vehicle
    Reporting group description
    Clin-RA Gel Vehicle

    Reporting group title
    Clindamycin
    Reporting group description
    Clindamycin phosphate 1.2% (in same vehicle as investigational product)

    Serious adverse events
    Clin RA Gel Tretinoin Vehicle Clindamycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 425 (0.24%)
    2 / 429 (0.47%)
    2 / 216 (0.93%)
    0 / 218 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 425 (0.00%)
    0 / 429 (0.00%)
    1 / 216 (0.46%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 425 (0.00%)
    1 / 429 (0.23%)
    0 / 216 (0.00%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
    Additional description: Hospitalization due to increase in behavior disorder
         subjects affected / exposed
    0 / 425 (0.00%)
    1 / 429 (0.23%)
    1 / 216 (0.46%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholethiasis
         subjects affected / exposed
    1 / 425 (0.24%)
    0 / 429 (0.00%)
    0 / 216 (0.00%)
    0 / 218 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Clin RA Gel Tretinoin Vehicle Clindamycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    117 / 425 (27.53%)
    127 / 429 (29.60%)
    46 / 216 (21.30%)
    59 / 218 (27.06%)
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 425 (2.35%)
    12 / 429 (2.80%)
    3 / 216 (1.39%)
    6 / 218 (2.75%)
         occurrences all number
    10
    12
    3
    6
    Cough
         subjects affected / exposed
    2 / 425 (0.47%)
    9 / 429 (2.10%)
    0 / 216 (0.00%)
    4 / 218 (1.83%)
         occurrences all number
    2
    9
    0
    4
    Nasopharyngitis
         subjects affected / exposed
    7 / 425 (1.65%)
    10 / 429 (2.33%)
    3 / 216 (1.39%)
    3 / 218 (1.38%)
         occurrences all number
    7
    10
    3
    3
    Pharyngolaryngeal pain
         subjects affected / exposed
    6 / 425 (1.41%)
    3 / 429 (0.70%)
    5 / 216 (2.31%)
    0 / 218 (0.00%)
         occurrences all number
    6
    3
    5
    0
    Sinusitis
         subjects affected / exposed
    4 / 425 (0.94%)
    9 / 429 (2.10%)
    2 / 216 (0.93%)
    2 / 218 (0.92%)
         occurrences all number
    4
    9
    2
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 425 (1.88%)
    8 / 429 (1.86%)
    3 / 216 (1.39%)
    6 / 218 (2.75%)
         occurrences all number
    8
    8
    3
    6
    Skin and subcutaneous tissue disorders
    Sunburn
         subjects affected / exposed
    6 / 425 (1.41%)
    11 / 429 (2.56%)
    1 / 216 (0.46%)
    3 / 218 (1.38%)
         occurrences all number
    6
    11
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2003
    Implemented changes to study procedures and analyses requested by the FDA

    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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