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    Clinical Trial Results:
    Effect of Patient Education on Treatment Adherence and Satisfaction among Acne Patients Receiving Once-Daily EpiduoTM Gel Treatment in Primary Care Clinics

    Summary
    EudraCT number
    		 2014-002509-39
    Trial protocol
    		 GB  
    Global end of trial date
    08 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2017
    First version publication date
    01 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RD.03.SPR.102710
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02307266
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galderma R&D
    Sponsor organisation address
    2400 route des colles, Biot, France, 06110
    Public contact
    Clinical Projet Manager, GALDERMA R&D, 33 493957068, gaelle.charier@galderma.com
    Scientific contact
    Clinical Projet Manager, GALDERMA R&D, 33 493957068, gaelle.charier@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
    01 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient eduction) on treatment adherence and satisfaction among acne patients receiving once daily Epiduo Gel treatment in primary carec clinics.
    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 Nov 2014
    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 Kingdom: 97
    Worldwide total number of subjects
    97
    EEA total number of subjects
    97
    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)
    39
    Adults (18-64 years)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    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
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of care + supplementary education
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adapalene 0.1% / Benzoyl peroxide 2.5%
    Investigational medicinal product code
    Other name
    Epiduo
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    application on the face, once daily

    Arm title
    		 Standard of care
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adapalene 0.1% / Benzoyl peroxide 2.5%
    Investigational medicinal product code
    Other name
    Epiduo
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    application on the face, once daily

    Arm title
    		 Standard of care + additional visits
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adapalene 0.1% / Benzoyl peroxide 2.5%
    Investigational medicinal product code
    Other name
    Epiduo
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    application on the face, once daily

    Number of subjects in period 1
    		Standard of care + supplementary education Standard of care Standard of care + additional visits
    Started
    33
    33
    31
    Completed
    25
    32
    25
    Not completed
    8
    1
    6
         Consent withdrawn by subject
    2
    -
    1
         Adverse event, non-fatal
    3
    1
    5
         Lost to follow-up
    3
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of care + supplementary education
    Reporting group description
    		 -

    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Reporting group title
    Standard of care + additional visits
    Reporting group description
    		 -

    Reporting group values
    		 Standard of care + supplementary education Standard of care Standard of care + additional visits Total
    Number of subjects
    		 33 33 31 97
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 8 14 17 39
        Adults (18-64 years)
    		 25 19 14 58
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.1 ( 9.6 ) 21 ( 7.9 ) 22.5 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 26 19 67
        Male
    		 11 7 12 30
    Race
    Units: Subjects
        White
    		 29 26 27 82
        Asian
    		 3 6 4 13
        Other
    		 1 1 0 2
    Skin phototype
    Units: Subjects
        Phototype I
    		 2 3 2 7
        Phototype II
    		 11 9 11 31
        Phototype III
    		 14 13 12 39
        Phototype IV
    		 5 6 4 15
        Phototype V
    		 1 2 2 5
    Investigator Global Assessment
    Investigator Global Assessment of acne
    Units: Subjects
        1: Almost clear
    		 8 1 3 12
        2: Mild
    		 17 22 20 59
        3: Moderate
    		 8 10 8 26
    Acne history
    Units: years
        arithmetic mean (standard deviation)
    		 5.7 ( 9.3 ) 4.4 ( 4.6 ) 4.7 ( 5.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Standard of care + supplementary education
    Reporting group description
    		 -

    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Reporting group title
    Standard of care + additional visits
    Reporting group description
    		 -

    Primary: Mean rate of adherence, as assessed by Medical Event Monitoring System (MEMS)

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    End point title
    		 Mean rate of adherence, as assessed by Medical Event Monitoring System (MEMS)
    End point description
    To prevent bias, treatment adhrence was assessed without subject's knowledge using a Medication Event Monitoring System( MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adhrence in % corresponds to the number of days the subject was adherent divided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: missing data were considered as non-adherence.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Standard of care + supplementary education Standard of care Standard of care + additional visits
    Number of subjects analysed
    20 [1]
    28 [2]
    23 [3]
    Units: Percentage of adherence
        arithmetic mean (standard deviation)
    63.1 ( 30.2 )
    56.5 ( 24.8 )
    48.2 ( 33.9 )
    Notes
    [1] - Worst-case population
    [2] - Worst-case population
    [3] - Worst-case population
    Statistical analysis title
    		 Comparison SoC + education vs SoC
    Comparison groups
    Standard of care + supplementary education v Standard of care
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3165
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Comparison SoC + education vs SoC + visits
    Comparison groups
    Standard of care + supplementary education v Standard of care + additional visits
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0206
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Standard of care + supplementary education
    Reporting group description
    		 -

    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Reporting group title
    Standard of care + additional visits
    Reporting group description
    		 -

    Serious adverse events
    		 Standard of care + supplementary education Standard of care Standard of care + additional visits
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Standard of care + supplementary education Standard of care Standard of care + additional visits
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 33 (21.21%)
    6 / 33 (18.18%)
    15 / 31 (48.39%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    3 / 31 (9.68%)
         occurrences all number
    1
    1
    3
    Dry skin
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 33 (6.06%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    2
    Erythema
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    1
    0
    2
    Pain of skin
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Rash
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 33 (3.03%)
    1 / 31 (3.23%)
         occurrences all number
    1
    1
    1
    Skin burning sensation
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    3
    Skin irritation
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
         occurrences all number
    2
    1
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 33 (3.03%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    1

    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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