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    Clinical Trial Results:
    Double-blind, randomized, vehicle-controlled, multi-centric trial to prove the therapeutic efficacy and tolerability of a liquid acne topical containing Clindamycin phosphate and Sodiumbituminosulfonate, pale versus vehicle and versus each of the single active substances in mild to moderate acne vulgaris

    Summary
    EudraCT number
    		 2009-013273-17
    Trial protocol
    		 DE   CZ  
    Global end of trial date
    18 Oct 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2018
    First version publication date
    15 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KF03/08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ICHTHYOL-GESELLSCHAFT Cordes, Hermanni & Co. (GmbH & Co.) KG
    Sponsor organisation address
    Sportallee 85, Hamburg, Germany, 22335
    Public contact
    Wiebke Fehrs, ICHTHYOL-GESELLSCHAFT Cordes, Hermanni & Co. (GmbH & Co.) KG, +49 4050714-353, wfehrs@ichthyol.de
    Scientific contact
    Wiebke Fehrs, ICHTHYOL-GESELLSCHAFT Cordes, Hermanni & Co. (GmbH & Co.) KG, +49 4050714-353, wfehrs@ichthyol.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000532-PIP01-09
    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
    18 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Oct 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The proof of superiority of the combination solution as compared to vehicle and to each of the mono preparations with reference to the improvement of acne-appearance in accordance with GAAS (comparison of the score at study start and end) in case of mild to moderate acne vulgaris.
    Protection of trial subjects
    All patients were treated with a Acne-Solution, which contains either - Isopropanol (Vehicle) or - Isopropanol plus Clindamycin phosphate 1% plus Sodium bituminosulfonate light 6% or - Isopropanol plus Clindamycin phosphate 1% or - Isopropanol plus Sodium bituminosulfonate light 6%. All these solutions were appropriate for the treatment of patients with "mild to moderate acne vulgaris in the area of the face, level 2 – 3 referring to GAAS" for the limited treatment period of 12 weeks during this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Feb 2010
    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
    Czech Republic: 84
    Country: Number of subjects enrolled
    Germany: 68
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    3
    Adolescents (12-17 years)
    98
    Adults (18-64 years)
    51
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 date of first enrolment: 12th February 2010 date of last completed: 18th October 2010

    Pre-assignment
    Screening details
    		 Patients were included who suffered from mild to moderate acne vulgaris in the face according to classification as per GAAS, level 2 = mild and 3 = moderate.

    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
    		 Investigational Medicinal Product (combination arm)
    Arm description
    		 clindamycin 2-dihydrogen phosphate 1.19 %, sodium bituminosulfonate light 6 %; solution
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Akne solution (active comparator) combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    application twice daily

    Arm title
    		 Comparator 1 (mono arm)
    Arm description
    		 clindamycin 2-dihydrogen phosphate 1.19 %; solution
    Arm type
    		 Comparator 1 (Mono Clindamycin)

    Investigational medicinal product name
    Akne solution (comparator 1) mono
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    solution was applied twice daily

    Arm title
    		 Comparator 2 (mono arm)
    Arm description
    		 sodium bituminosulfonate light 6 %; solution
    Arm type
    		 Comparator 2 (Mono Sodium bituminosulfonate light)

    Investigational medicinal product name
    Akne solution (comparator 2) mono
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Application twice daily for 12 weeks

    Arm title
    		 Comparator 3 (vehicle arm)
    Arm description
    		 Vehicle: solution with Isopropanol
    Arm type
    		 Vehicle (solution Isopropanol)

    Investigational medicinal product name
    Akne solution (comparator 3) vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    Application twice daily for 12 weeks

    Number of subjects in period 1
    		Investigational Medicinal Product (combination arm) Comparator 1 (mono arm) Comparator 2 (mono arm) Comparator 3 (vehicle arm)
    Started
    61
    30
    30
    31
    Completed
    59
    30
    29
    30
    Not completed
    2
    0
    1
    1
         Consent withdrawn by subject
    2
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 overall trial (overall period) Total
    Number of subjects
    		 152 152
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 3 3
        Adolescents (12-17 years)
    		 98 98
        Adults (18-64 years)
    		 51 51
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 78 78
        Male
    		 74 74

    End points

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    End points reporting groups
    Reporting group title
    Investigational Medicinal Product (combination arm)
    Reporting group description
    		 clindamycin 2-dihydrogen phosphate 1.19 %, sodium bituminosulfonate light 6 %; solution

    Reporting group title
    Comparator 1 (mono arm)
    Reporting group description
    		 clindamycin 2-dihydrogen phosphate 1.19 %; solution

    Reporting group title
    Comparator 2 (mono arm)
    Reporting group description
    		 sodium bituminosulfonate light 6 %; solution

    Reporting group title
    Comparator 3 (vehicle arm)
    Reporting group description
    		 Vehicle: solution with Isopropanol

    Primary: The main objective of this trial was the proof of superiority of the combination clindamycin + bituminosulfonate as compared to vehicle and to each of the mono preparations with reference to achieving success based on the GAAS.

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    End point title
    		 The main objective of this trial was the proof of superiority of the combination clindamycin + bituminosulfonate as compared to vehicle and to each of the mono preparations with reference to achieving success based on the GAAS.
    End point description
    End point type
    Primary
    End point timeframe
    considering treatment success (none or minimal acne) after 12 weeks of treatment
    End point values
    		 Investigational Medicinal Product (combination arm) Comparator 1 (mono arm) Comparator 2 (mono arm) Comparator 3 (vehicle arm)
    Number of subjects analysed
    61
    30
    30
    31
    Units: GAAS (Global Acne Assessment Score)
    61
    30
    30
    31
    Statistical analysis title
    		 proof of superiority
    Statistical analysis description
    The main objective of this trial was the proof of superiority of the combination clindamycin + bituminosulfonate as compared to vehicle and to each of the mono preparations with reference to achieving success based on the GAAS. Success on the 5-point scale was defined as a rating of “none” (0) or “minimal” (1) after 12 weeks.
    Comparison groups
    Investigational Medicinal Product (combination arm) v Comparator 1 (mono arm) v Comparator 2 (mono arm) v Comparator 3 (vehicle arm)
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Febr 2010 - Oct 2010
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    combination arm (clindamycin+bituminosulfonate)
    Reporting group description
    		 -

    Serious adverse events
    		 combination arm (clindamycin+bituminosulfonate)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 61 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 combination arm (clindamycin+bituminosulfonate)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 61 (1.64%)
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    3

    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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