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

    Summary
    EudraCT number
    		 2010-022919-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Mar 2006

    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
    MP-1501-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dow Pharmaceutical Sciences, Inc.
    Sponsor organisation address
    1330A Redwood Way, Petaluma, United States, CA 94954-1169
    Public contact
    Group leader study manager, MEDA Pharma GmbH & Co. KG, +49 617288801, 42b@medapharma.de
    Scientific contact
    Head of Corporate Clinical Affairs, MEDA Pharma GmbH & Co. KG, +49 617288801, 42b@medapharma.de
    Sponsor organisation name
    Medicis Pharmaceutical Corp.
    Sponsor organisation address
    8125 North Hayden Road, Scottsdate, United States, AZ 85258
    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
    21 Apr 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2006
    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 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
    09 Sep 2005
    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: 2010
    Worldwide total number of subjects
    2010
    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)
    1320
    Adults (18-64 years)
    689
    From 65 to 84 years
    1
    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, with 20 to 50 inflammatory lesions (papules and pustules), 20 to 100 noninflammatory lesions (open and closed comedones), no more than 2 nodules, and an Evaluator’s Global Severity Score (EGSS) of moderate (=3) or severe (=4).

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Clin RA Gel
    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
    once-a-day application (at bedtime); 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
    once-a-day application (at bedtime); topically applied to the face

    Number of subjects in period 1
    		Clin RA Gel Clindamycin
    Started
    1008
    1002
    Completed
    859
    838
    Not completed
    149
    164
         Consent withdrawn by subject
    27
    20
         Adverse event, non-fatal
    6
    2
         Other
    5
    3
         Subject request
    17
    28
         Lost to follow-up
    92
    108
         Protocol deviation
    1
    -
         Noncompliance
    1
    3

    Baseline characteristics

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

    Reporting group title
    Clindamycin
    Reporting group description
    		 -

    Reporting group values
    		 Clin RA Gel Clindamycin Total
    Number of subjects
    		 1008 1002 2010
    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)
    		 19.1 ( 7.5 ) 19 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 493 547 1040
        Male
    		 515 455 970

    End points

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

    Reporting group title
    Clindamycin
    Reporting group description
    		 -

    Primary: Dichotomized Evaluator's Global Severity Score

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    End point title
    		 Dichotomized Evaluator's Global Severity Score
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and week 12.
    End point values
    		 Clin RA Gel Clindamycin
    Number of subjects analysed
    1008
    1002
    Units: Success, Failure
        Success
    381
    318
        Failure
    627
    684
    Statistical analysis title
    		 Clin-RA vs Clindamycin
    Comparison groups
    Clin RA Gel v Clindamycin
    Number of subjects included in analysis
    2010
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    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 Gel Clindamycin
    Number of subjects analysed
    1008
    1002
    Units: percent change
        median (full range (min-max))
    70 (-215.6 to 100)
    64.5 (-146.4 to 100)
    Statistical analysis title
    		 Clin-RA vs Clindamycin
    Comparison groups
    Clin RA Gel v Clindamycin
    Number of subjects included in analysis
    2010
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    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 Gel Clindamycin
    Number of subjects analysed
    1008
    1002
    Units: percent change
        median (full range (min-max))
    57.6 (-157.8 to 100)
    48.2 (-184.6 to 100)
    Statistical analysis title
    		 Clin-RA vs Clindamycin
    Comparison groups
    Clin RA Gel v Clindamycin
    Number of subjects included in analysis
    2010
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    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 Gel Clindamycin
    Number of subjects analysed
    1008
    1002
    Units: percent change
        median (full range (min-max))
    62 (-97.4 to 100)
    53.1 (-107.4 to 100)
    Statistical analysis title
    		 Clin-RA vs Clindamycin
    Comparison groups
    Clin RA Gel v Clindamycin
    Number of subjects included in analysis
    2010
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    during 12 weeks of treatment, until 30 days post-treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    Clindamycin
    Reporting group description
    		 Clindamycin phosphate 1.2% gel (in the same vehicle as the investigational product); once-a-day application (at bedtime); topically applied to the face

    Reporting group title
    Clin RA Gel
    Reporting group description
    		 Clindamycin phosphate 1.2% and tretinoin 0.025% once-a-day application (at bedtime); topically applied to the face

    Serious adverse events
    		 Clindamycin Clin RA Gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 1002 (0.30%)
    2 / 1008 (0.20%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 1008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominoplasty
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 1008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 1008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional selfinjury
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 1008 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 1008 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Clindamycin Clin RA Gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    235 / 1002 (23.45%)
    269 / 1008 (26.69%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 1002 (1.20%)
    20 / 1008 (1.98%)
         occurrences all number
    12
    20
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 1002 (0.70%)
    11 / 1008 (1.09%)
         occurrences all number
    7
    11
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    16 / 1002 (1.60%)
    19 / 1008 (1.88%)
         occurrences all number
    16
    19
    Cough
         subjects affected / exposed
    15 / 1002 (1.50%)
    12 / 1008 (1.19%)
         occurrences all number
    15
    12
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    7 / 1002 (0.70%)
    20 / 1008 (1.98%)
         occurrences all number
    7
    20
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    54 / 1002 (5.39%)
    51 / 1008 (5.06%)
         occurrences all number
    54
    51
    Upper respiratory tract infection
         subjects affected / exposed
    17 / 1002 (1.70%)
    12 / 1008 (1.19%)
         occurrences all number
    17
    12
    Pharyngitis streptococcal
         subjects affected / exposed
    12 / 1002 (1.20%)
    9 / 1008 (0.89%)
         occurrences all number
    12
    9
    Sinusitis
         subjects affected / exposed
    14 / 1002 (1.40%)
    12 / 1008 (1.19%)
         occurrences all number
    14
    12
    Influenza
         subjects affected / exposed
    7 / 1002 (0.70%)
    11 / 1008 (1.09%)
         occurrences all number
    7
    11
    Gastroenteritis viral
         subjects affected / exposed
    11 / 1002 (1.10%)
    9 / 1008 (0.89%)
         occurrences all number
    11
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2005
    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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