Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Benzaknen® 5% Gel in combination with Dermotivin® Soft Liquid cleanser and non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the treatment of mild-to-moderate acne vulgaris

    Summary
    EudraCT number
    		 2015-001448-13
    Trial protocol
    		 DE  
    Global end of trial date
    15 Jan 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Sep 2017
    First version publication date
    13 May 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    correction needed on end point value

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RD.03.SPR.105041
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02589405
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D
    Sponsor organisation address
    240 routes des colles, BIOT, France, 06410
    Public contact
    Stéphanie Leclerc, Galderma R&D, +33 492386706, Stephanie.Leclerc@galderma.com
    Scientific contact
    Stéphanie Leclerc, Galderma R&D, +33 492386706, Stephanie.Leclerc@galderma.com
    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
    04 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 after 12 weeks of treatment.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Aug 2015
    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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    21
    Adults (18-64 years)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No screening

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment regimen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benzaknen® 5% Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Application on the face once daily

    Investigational medicinal product name
    Dermotivin® Soft Liquid soap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Topical use
    Dosage and administration details
    Application on the face twice daily (morning/evening)

    Investigational medicinal product name
    Cetaphil® Dermacontrol Moisturizer SPF30
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Application on the face once daily (evening)

    Number of subjects in period 1
    		Treatment regimen
    Started
    50
    Completed
    46
    Not completed
    4
         Adverse event, non-fatal
    3
         Subject's request
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment regimen
    Reporting group description
    		 -

    Reporting group values
    		 Treatment regimen Total
    Number of subjects
    		 50 50
    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)
    		 0 0
        Adolescents (12-17 years)
    		 21 21
        Adults (18-64 years)
    		 29 29
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 21.8 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 17 17
    Skin phototype
    Units: Subjects
        Phototype I
    		 1 1
        Phototype II
    		 25 25
        Phototype III
    		 21 21
        Phototype IV
    		 3 3
    Investigator Global Assessment
    Units: Subjects
        Mild
    		 37 37
        Moderate
    		 13 13
        Severe
    		 0 0
    Acne duration
    Units: Years
        arithmetic mean (standard deviation)
    		 9.8 ( 7.4 ) -
    Total lesions count
    Units: Lesion
        arithmetic mean (standard deviation)
    		 97 ( 45.6 ) -
    Non-Inflammatory lesions
    Units: Lesions
        arithmetic mean (standard deviation)
    		 68.1 ( 37.2 ) -
    Inflammatory Lesions
    Units: Lesions
        arithmetic mean (standard deviation)
    		 28.9 ( 21.7 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment regimen
    Reporting group description
    		 -

    Subject analysis set title
    Treatment regimen
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    This population consists of the Intent-to-Treat population, after exclusion of subjects who never took the treatment with certainty based on the monitoring report

    Primary: Subject Overall satisfaction with the three-part treatment regimen

    		 Close Top of page
    End point title
    		 Subject Overall satisfaction with the three-part treatment regimen [1]
    End point description
    Percentage of subjects satisfied and very satisfied with the three-part treatment regimen
    End point type
    Primary
    End point timeframe
    Week 12
    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 inferential statistics will be performed. All variables have been descriptively summarized on ITT population and on safety population .
    End point values
    		 Treatment regimen
    Number of subjects analysed
    48
    Units: Percent subjects
        number (not applicable)
    87.5
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Week 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Overall population
    Reporting group description
    		 -

    Serious adverse events
    		 Overall population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 50 (2.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Overall population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 50 (26.00%)
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Radius fracture
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Tenosynovitis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Impetigo
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Mucosal infection
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 50 (8.00%)
         occurrences all number
    4
    Pharyngitis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    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.

    European Medicines Agency © 1995-Fri Apr 26 22:47:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA