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    Clinical Trial Results:
    AN OPEN-LABEL STUDY ASSESSING LONG-TERM SAFETY OF DRM04 IN SUBJECTS WITH PRIMARY AXILLARY HYPERHIDROSIS

    Summary
    EudraCT number
    		 2015-002163-42
    Trial protocol
    		 DE  
    Global end of trial date
    12 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jan 2018
    First version publication date
    29 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRM04-HH06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02553798
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dermira, Inc.
    Sponsor organisation address
    275 Middlefield Road, Ste 150, Menlo Park, United States, 94025
    Public contact
    Chief Medical Officer, Dermira, Inc., 001 6504217202, eugene.bauer@dermira.com
    Scientific contact
    Chief Medical Officer, Dermira, Inc., 001 6504217202, eugene.bauer@dermira.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
    12 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to assess the long-term safety of DRM04 Topical Wipes, 3.75% in subjects with primary axillary hyperhidrosis in a minimum of 100 subjects for at least 12 months.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards and applicable country and/or local statues and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 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: 44
    Country: Number of subjects enrolled
    United States: 520
    Worldwide total number of subjects
    564
    EEA total number of subjects
    44
    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)
    1
    Adolescents (12-17 years)
    46
    Adults (18-64 years)
    512
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subject participated in DRM04-HH04 or DRM04-HH05 study

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

    Arms
    Arm title
    		 DRM04, 3.75%
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    DRM04, 3.75%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    DRM04 3.75% solution applied once daily to the axillae for up to 44 weeks

    Number of subjects in period 1
    		DRM04, 3.75%
    Started
    564
    Completed
    226
    Not completed
    338
         Consent withdrawn by subject
    82
         Physician decision
    1
         Study terminated by Sponsor
    106
         Adverse event, non-fatal
    44
         Pregnancy
    3
         Lost to follow-up
    92
         Protocol deviation
    2
         Noncompliance
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 564 564
    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)
    		 1 1
        Adolescents (12-17 years)
    		 46 46
        Adults (18-64 years)
    		 512 512
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 309 309
        Male
    		 255 255

    End points

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    End points reporting groups
    Reporting group title
    DRM04, 3.75%
    Reporting group description
    		 -

    Primary: Long term Safety

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    End point title
    		 Long term Safety [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline - Week 44/ET
    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: Uncontrolled trial - no inferential statistics were planned for this study.
    End point values
    		 DRM04, 3.75%
    Number of subjects analysed
    550
    Units: Adverse Events and LSRs
        Mild AEs
    148
        Moderate AEs
    153
        Severe AEs
    28
        Mild LSRs
    120
        Moderate LSRs
    44
        Severe LSRs
    15
    No statistical analyses for this end point

    Secondary: Gravimetrically-Measured Sweat Production

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    End point title
    		 Gravimetrically-Measured Sweat Production
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline - Week 44/ET
    End point values
    		 DRM04, 3.75%
    Number of subjects analysed
    430
    Units: mg/5 min
        arithmetic mean (standard deviation)
    -95.68 ( 140.806 )
    No statistical analyses for this end point

    Secondary: Hyperhidrosis Disease Severity Score

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    End point title
    		 Hyperhidrosis Disease Severity Score
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline - Week 44/ET
    End point values
    		 DRM04, 3.75%
    Number of subjects analysed
    437
    Units: Changes from Baseline at Week 44/ET
        3 - point improvement
    72
        2 - point improvement
    204
        1 - point improvement
    135
        no improvement
    26
    No statistical analyses for this end point

    Secondary: Quality of Life - DLQI

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    End point title
    		 Quality of Life - DLQI
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline - Week 44/ET
    End point values
    		 DRM04, 3.75%
    Number of subjects analysed
    406
    Units: change from Baseline at Week 44/ET
        arithmetic mean (standard deviation)
    -8.7 ( 6.24 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    DRM04, 3.75%
    Reporting group description
    		 -

    Serious adverse events
    		 DRM04, 3.75%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 550 (1.27%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Mydriasis
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Affective disorder
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 550 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DRM04, 3.75%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    226 / 550 (41.09%)
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    35 / 550 (6.36%)
         occurrences all number
    58
    Eye disorders
    Vision blurred
         subjects affected / exposed
    37 / 550 (6.73%)
         occurrences all number
    45
    Mydriasis
         subjects affected / exposed
    29 / 550 (5.27%)
         occurrences all number
    38
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    93 / 550 (16.91%)
         occurrences all number
    136
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    32 / 550 (5.82%)
         occurrences all number
    36

    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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