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    Clinical Trial Results:
    A multicenter, randomized, parallel, double-blind, clinical trial study to assess the efficacy and safety of Fluocinolone Acetonide 0.025% Otic Solution compared to Placebo in patients with otic eczema.

    Summary
    EudraCT number
    		 2011-004172-11
    Trial protocol
    		 ES  
    Global end of trial date
    22 Mar 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    09 Jul 2015
    Other versions
    Summary report(s)
    		 FLUOTIII/11ES01 Synopsis CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    FLUOTIII/11ES01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01996748
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios SALVAT, S.A.
    Sponsor organisation address
    Gall, 30-36, Esplugues de Llobregat, Spain, 08950
    Public contact
    Medical Department, Laboratorios SALVAT, S.A., +34 933946469, clinicaltrials@salvatbiotech.com
    Scientific contact
    Medical Department, Laboratorios SALVAT, S.A., +34 933946470, ejimenezv@salvatbiotech.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
    22 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Fluocinolone Acetonide 0.025% otic solution compared to placebo for the reduction of itching after 8 days of starting treatment in patients with otic eczema.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 The availability of medical treatment is very diverse depending on the EU country; there is not a “gold standard” for this condition. In the absence of a general well established treatment and based on the NOTE FOR GUIDANCE ON CHOICE OF CONTROL GROUP IN CLINICAL TRIALS (CPMP/ICH/364/96), a placebo controlled trial was considered the best design option.
    Actual start date of recruitment
    09 Mar 2012
    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
    Spain: 135
    Worldwide total number of subjects
    135
    EEA total number of subjects
    135
    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)
    0
    Adults (18-64 years)
    109
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period was from 9th March 2012 to 22nd March 2013.

    Pre-assignment
    Screening details
    		 Male and female patients aged 12 years or older with clinical diagnosis of otic eczema suitable for local treatment according to the investigator. Patients must have moderate or severe itching in the ear canal (with or without involvement of the pinna), and otoscopic image of scaling in the ear canal skin.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Both Fluocinolone Acetonide 0.025% otic solution and the placebo had identical organoleptical characteristics. The randomization data remained strictly confidential and only authorized persons had access, until the definitive creation of the database. In case of emergency, for opening the randomization codes, there were a complete set of emergency codes at the investigator’s site. The opening of said codes had to be reported to the study monitor immediately and duly recorded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluocinolone acetonide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluocinolone acetonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution in single-dose container
    Routes of administration
    Auricular use
    Dosage and administration details
    Administer the contents of one 0.40 ml single dose vial twice a day to the affected ear(s) for seven days

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ear drops, solution in single-dose container
    Routes of administration
    Auricular use
    Dosage and administration details
    Administer the contents of one 0.40ml single-dose vial twice a day to the affected ear(s) for seven days

    Number of subjects in period 1
    		Fluocinolone acetonide Placebo
    Started
    66
    69
    Completed
    58
    63
    Not completed
    8
    6
         Physician decision
    2
    -
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    4
         peronal reasons
    1
    -
         Lost to follow-up
    4
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Fluocinolone acetonide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in itching on Days 4-8 compared to baseline

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    End point title
    		 Change in itching on Days 4-8 compared to baseline
    End point description
    End point type
    Primary
    End point timeframe
    Day 4-8
    End point values
    		 Fluocinolone acetonide Placebo
    Number of subjects analysed
    63
    68
    Units: scores
        arithmetic mean (inter-quartile range (Q1-Q3))
    -1.63 (-2 to -1.1)
    -1.25 (-1.75 to -0.84)
    Statistical analysis title
    		 ANCOVA on the itching change from baseline
    Comparison groups
    Fluocinolone acetonide v Placebo
    Number of subjects included in analysis
    131
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All study period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Fluocinolone Acetonide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Fluocinolone Acetonide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 66 (0.00%)
    0 / 69 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fluocinolone Acetonide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 66 (7.58%)
    9 / 69 (13.04%)
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    3 / 66 (4.55%)
    4 / 69 (5.80%)
         occurrences all number
    4
    4
    Ear disorder
         subjects affected / exposed
    1 / 66 (1.52%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    0 / 66 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 66 (0.00%)
    4 / 69 (5.80%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2012
    Inclusion of a new centre.

    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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