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    Clinical Trial Results:
    A Multi-Center, Phase 3, Randomized, Double-Blind, 4-Arm Clinical Trial to Compare the Safety and Efficacy of Clin-RA Gel vs. Clindamycin Phosphate 1.2% Gel vs. Tretinoin 0.025% Gel vs. Clin-RA Gel Vehicle in the Treatment of Acne Vulgaris

    Summary
    EudraCT number
    		 2010-022911-20
    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-06-02
    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
    22 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: 1252
    Worldwide total number of subjects
    1252
    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)
    4
    Adolescents (12-17 years)
    796
    Adults (18-64 years)
    452
    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Clin-RA
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clindamycin phosphate and Tretinoin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Clindamycin phosphate 1.2% and Tretinoin 0.025% Dosing: Once daily (at bedtime) x 12 weeks, Mode of Administration: Topically applied to the face

    Arm title
    		 Clindamycin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clindamycin phosphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Dosing: Once daily (at bedtime) x 12 weeks, Concentration: Clindamycin phosphate 1.2%, Mode of Administration: Topically applied to the face

    Arm title
    		 Tretinoin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tretinoin
    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) x 12 weeks, Concentration: Tretinoin 0.025%, 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) x 12 weeks; Mode of Administration: Topically applied to the face

    Number of subjects in period 1
    		Clin-RA Clindamycin Tretinoin Vehicle
    Started
    420
    208
    417
    207
    Completed
    366
    176
    363
    182
    Not completed
    54
    32
    54
    25
         Adverse event, non-fatal
    6
    1
    4
    1
         Other
    7
    1
    1
    2
         Subject request
    5
    9
    19
    6
         Lost to follow-up
    26
    13
    18
    11
         Inappropriate Enrollment
    1
    4
    6
    1
         Pregnancy
    1
    -
    1
    -
         Protocol deviation
    2
    2
    3
    1
         Lack of efficacy
    6
    2
    2
    3

    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
    		 420 208 417 207 1252
    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)
    		 18.36 ± 6.68 18.99 ± 7.16 18.98 ± 7.31 18.6 ± 7.52 -
    Gender categorical
    Units: Subjects
        Female
    		 198 91 202 110 601
        Male
    		 222 117 215 97 651

    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
    420
    208
    417
    207
    Units: Success, Failure
        Success
    85
    32
    62
    18
        Failure
    335
    176
    355
    189
    Statistical analysis title
    		 Clin-RA vs. Clindamycin
    Comparison groups
    Clindamycin v Clin-RA
    Number of subjects included in analysis
    628
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.147
    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
    837
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    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
    627
    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
    420
    208
    417
    207
    Units: percent change
        median (full range (min-max))
    52.6 (-233 to 100)
    46.4 (-190 to 100)
    42.9 (-167 to 100)
    25 (-188 to 100)
    Statistical analysis title
    		 Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    628
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 Ranked ANOVA
    Confidence interval
    Statistical analysis title
    		 Clin-RA vs. Tretinoin
    Comparison groups
    Clin-RA v Tretinoin
    Number of subjects included in analysis
    837
    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
    627
    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
    420
    208
    417
    207
    Units: percent change
        median (full range (min-max))
    43.8 (-197 to 100)
    27.5 (-265 to 100)
    36.2 (-226 to 100)
    23 (-212 to 100)
    Statistical analysis title
    		 Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    628
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Ranked ANOVA
    Confidence interval
    Statistical analysis title
    		 Clin-RA vs. Tretinoin
    Comparison groups
    Clin-RA v Tretinoin
    Number of subjects included in analysis
    837
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018
    Method
    		 Ranked ANOVA
    Confidence interval
    Statistical analysis title
    		 Clin-RA vs. Vehicle
    Comparison groups
    Clin-RA v Vehicle
    Number of subjects included in analysis
    627
    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
    420
    208
    417
    207
    Units: percent change
        median (full range (min-max))
    46.3 (-122 to 100)
    33.9 (-138 to 96)
    39.6 (-124 to 100)
    22.2 (-153 to 97)
    Statistical analysis title
    		 Clin-RA vs. Clindamycin
    Comparison groups
    Clin-RA v Clindamycin
    Number of subjects included in analysis
    628
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Ranked ANOVA
    Confidence interval
    Statistical analysis title
    		 Clin-RA vs. Tretinoin
    Comparison groups
    Clin-RA v Tretinoin
    Number of subjects included in analysis
    837
    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
    627
    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
    Up to 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
    Reporting group description
    		 Intent-to-Treat Subjects.

    Reporting group title
    Tretinoin
    Reporting group description
    		 Intent-to-Treat Subjects.

    Reporting group title
    Vehicle
    Reporting group description
    		 Intent-to-Treat Subjects.

    Reporting group title
    Clindamycin
    Reporting group description
    		 Intent-to-Treat Subjects.

    Serious adverse events
    		 Clin-RA Tretinoin Vehicle Clindamycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 420 (0.95%)
    1 / 417 (0.24%)
    0 / 207 (0.00%)
    2 / 208 (0.96%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Ligament injury
         subjects affected / exposed
    0 / 420 (0.00%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    1 / 208 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: 3 SAEs of same patient (abdominal pain, cholelithiasis, cholecystitis)
         subjects affected / exposed
    1 / 420 (0.24%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    0 / 208 (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
    Oesophageal pain
         subjects affected / exposed
    0 / 420 (0.00%)
    1 / 417 (0.24%)
    0 / 207 (0.00%)
    0 / 208 (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
    Hepatobiliary disorders
    Cholelithiasis
    Additional description: 3 SAEs of same patient (abdominal pain, cholelithiasis, cholecystitis)
         subjects affected / exposed
    1 / 420 (0.24%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    0 / 208 (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
    Cholecystitis
         subjects affected / exposed
    1 / 420 (0.24%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    0 / 208 (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
    Psychiatric disorders
    Drug dependence
         subjects affected / exposed
    1 / 420 (0.24%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    0 / 208 (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
    Musculoskeletal and connective tissue disorders
    Fracture
         subjects affected / exposed
    2 / 420 (0.48%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    1 / 208 (0.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint sprain
         subjects affected / exposed
    0 / 420 (0.00%)
    0 / 417 (0.00%)
    0 / 207 (0.00%)
    1 / 208 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2.5%
    Non-serious adverse events
    		 Clin-RA Tretinoin Vehicle Clindamycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 420 (25.48%)
    96 / 417 (23.02%)
    43 / 207 (20.77%)
    43 / 208 (20.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 420 (2.62%)
    4 / 417 (0.96%)
    7 / 207 (3.38%)
    6 / 208 (2.88%)
         occurrences all number
    11
    4
    7
    6
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 420 (2.62%)
    12 / 417 (2.88%)
    8 / 207 (3.86%)
    2 / 208 (0.96%)
         occurrences all number
    11
    12
    8
    2
    Nasopharyngitis
         subjects affected / exposed
    6 / 420 (1.43%)
    6 / 417 (1.44%)
    2 / 207 (0.97%)
    7 / 208 (3.37%)
         occurrences all number
    6
    6
    2
    7
    Skin and subcutaneous tissue disorders
    Application site dryness
         subjects affected / exposed
    11 / 420 (2.62%)
    11 / 417 (2.64%)
    5 / 207 (2.42%)
    1 / 208 (0.48%)
         occurrences all number
    11
    11
    5
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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