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    Clinical Trial Results:
    Safety Dermatological Evaluation: genital mucosa irritation - Product tested: Dermacyd PH_DETINBACK Sweet Flower

    Summary
    EudraCT number
    		 2014-004663-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Sep 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_04301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00785850
    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,
    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
    20 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To prove the safety of the gynecological liquid soap 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
    21 Aug 2008
    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)
    5
    Adolescents (12-17 years)
    18
    Adults (18-64 years)
    8
    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 21 august 2008 and 17 september 2008.

    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
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 5 5
        Adolescents (12-17 years)
    		 18 18
        Adults (18-64 years)
    		 8 8
        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
    Subject exposed to Lactic Acid
    Reporting group description
    		 -

    Serious adverse events
    		 Subject 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
    		 Subject 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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    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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