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    Clinical Trial Results:
    A single center, randomized, controlled study to determine the irritant potential of topical acne formulations on intact healthy skin on the back following repeated application during a 21-day treatment period

    Summary
    EudraCT number
    		 2009-014550-14
    Trial protocol
    		 DE  
    Global end of trial date
    01 Feb 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DPSI-Acanya-P4-02 / 290622BS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dow Pharmaceutical Sciences, Inc.
    Sponsor organisation address
    1330 Redwood Way, Petaluma, United States, 94954-7121
    Public contact
    Project Manager, Dow Pharmaceuticals, +1 707-796-7226,
    Scientific contact
    Project Manager, Dow Pharmaceuticals, +1 707-796-7226,
    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
    01 Feb 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the irritant potential of Acanya® compared to Duac® and BenzaClin®.
    Protection of trial subjects
    The study was performed in accordance with the currently valid Declaration of Helsinki as well as German regulations. The ICH guideline for GCP (January 1997) was observed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 2009
    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
    Germany: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Men and women aged 18 years or older with healthy skin in the area of the test fields.

    Period 1
    Period 1 title
    Treatment (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
    No

    Arm title
    		 Acanya® Gel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    clindamycin 1 % / benzoyl peroxide 2.5 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of approximately 200 μl formulation per test field (approximately 2.5 cm2) once daily

    Arm title
    		 Duac® Topical Gel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    clindamycin 1 % / benzoyl peroxide 5 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of approximately 200 μl formulation per test field (approximately 2.5 cm2) once daily

    Arm title
    		 BenzaClin® Topical Gel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    clindamycin 1 % / benzoyl peroxide 5 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of approximately 200 μl formulation per test field (approximately 2.5 cm2) once daily

    Arm title
    		 Acanya® Gel + topical retinoid
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    clindamycin 1 % / benzoyl peroxide 2.5 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of approximately 200 μl formulation per test field (approximately 2.5 cm2) once daily

    Arm title
    		 Petrolatum
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Petrolatum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of approximately 200 μl formulation per test field (approximately 2.5 cm2) once daily

    Arm title
    		 Sodium lauryl sulfate
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    0.25 % sodium lauryl sulfate in water
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Topical application of approximately 200 μl formulation per test field (approximately 2.5 cm2) once daily

    Number of subjects in period 1
    		Acanya® Gel Duac® Topical Gel BenzaClin® Topical Gel Acanya® Gel + topical retinoid Petrolatum Sodium lauryl sulfate
    Started
    33
    33
    33
    33
    33
    33
    Completed
    32
    32
    32
    32
    32
    32
    Not completed
    1
    1
    1
    1
    1
    1
         Protocol deviation
    1
    1
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 There were 33 subjects in the study. Each subject was treated with each treatment group in designated areas on the skin.

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 33 33
    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)
    		 43.3 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Acanya® Gel
    Reporting group description
    		 -

    Reporting group title
    Duac® Topical Gel
    Reporting group description
    		 -

    Reporting group title
    BenzaClin® Topical Gel
    Reporting group description
    		 -

    Reporting group title
    Acanya® Gel + topical retinoid
    Reporting group description
    		 -

    Reporting group title
    Petrolatum
    Reporting group description
    		 -

    Reporting group title
    Sodium lauryl sulfate
    Reporting group description
    		 -

    Primary: Cumulative Irritation Score at Day 22

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    End point title
    		 Cumulative Irritation Score at Day 22 [1]
    End point description
    End point type
    Primary
    End point timeframe
    22 days
    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: No confirmatory hypotheses were formulated for this study.
    End point values
    		 Acanya® Gel Duac® Topical Gel BenzaClin® Topical Gel Acanya® Gel + topical retinoid Petrolatum Sodium lauryl sulfate
    Number of subjects analysed
    33
    33
    33
    33
    33
    33
    Units: Score
        arithmetic mean (standard deviation)
    34.97 ± 7.35
    32.42 ± 7.55
    35.97 ± 7.70
    42.26 ± 4.29
    0.82 ± 1.51
    50.67 ± 1.11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    22 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Not corresponding to a treatment
    Reporting group description
    		 -

    Reporting group title
    SLS treated area
    Reporting group description
    		 Each subject had designed areas treated with each treatment group.

    Serious adverse events
    		 Not corresponding to a treatment SLS treated area
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (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
    		 Not corresponding to a treatment SLS treated area
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    General disorders and administration site conditions
    Application site pruritis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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