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    Clinical Trial Results:
    Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

    Summary
    EudraCT number
    2014-004660-37
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Jan 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    16 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LACAC_L_03732
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00663273
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi-aventis Farmacêutica Ltda
    Sponsor organisation address
    Avenida Major Sylvio de Magalhães Padilha, Sao Paulo, Brazil, 5.200
    Public contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jan 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To prove the safety of the gynecological formulation in normal and usual use conditions
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. A consent form was signed by the parent(s)/guardian(s).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Dec 2007
    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
    Brazil: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    0
    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)
    9
    Adolescents (12-17 years)
    18
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was performed in one center in Brazil. A total of 31 subjects were enrolled between 17 December 2007 and 21 december 2007.

    Pre-assignment
    Screening details
    NA

    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
    Lactic Acid
    Arm description
    Lactic Acid on the external genital area for 21 days
    Arm type
    Experimental

    Investigational medicinal product name
    Lactic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal liquid
    Routes of administration
    Topical use
    Dosage and administration details
    Liquid soap applied in the external genital area, in small quantity, with abundantly rinse after use.

    Number of subjects in period 1
    Lactic Acid
    Started
    31
    Completed
    30
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lactic Acid
    Reporting group description
    Lactic Acid on the external genital area for 21 days

    Reporting group values
    Lactic Acid Total
    Number of subjects
    31 31
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Children (2-11 years)
    9 9
        Adolescents (12-17 years)
    18 18
        Infants and toddlers (28 days-23 months)
    0 0
        Adults (18-64 years)
    4 4
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    31 31
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Lactic Acid
    Reporting group description
    Lactic Acid on the external genital area for 21 days

    Primary: Number of subjects with skin reaction in the tested region

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    End point title
    Number of subjects with skin reaction in the tested region [1]
    End point description
    level of skin reaction was evaluated by presence of erythema, edema, desquamation, vesiculation, ardor and itching and their intensity (mild, moderate, severe) and their causality
    End point type
    Primary
    End point timeframe
    21 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: Statistical analysis plan included only descriptive statistics.
    End point values
    Lactic Acid
    Number of subjects analysed
    30 [2]
    Units: Subject
        Edema
    0
        Desquamation
    0
        Vesiculation
    0
        Ardor
    0
        Itching
    0
    Notes
    [2] - One subject did not return for final evaluation.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    21 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Subjects exposed to Lactic Acid
    Reporting group description
    -

    Serious adverse events
    Subjects exposed to Lactic Acid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Subjects exposed to Lactic Acid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse event was reported during the trial.

    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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