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    Clinical Trial Results:
    Hibiscrub EN12791 Testing using current application and 2 new application methods

    Summary
    EudraCT number
    		 2006-005470-41
    Trial protocol
    		 GB  
    Global end of trial date
    12 Jan 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2019
    First version publication date
    29 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CTR0028
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regent Medical
    Sponsor organisation address
    Two Omega Drive, Irlam, United Kingdom, M44 5BJ
    Public contact
    Caroline Scott, Molnlycke Health Care, caroline.scott@molnlycke.com
    Scientific contact
    Suchismita Roy, Molnlycke Health Care, suchismita.roy@molnlycke.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 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the study is to assess the suitability of a hand disinfectant product for surgical hand disinfection. The study will evaluate the hand disinfectant against a reference standard. Primary Endpoints- 1. Immediate effect - Reduction of the release of skin flora from the hands as assessed immediately after surgical hand disinfection. 2. 3-hour effect – Reduction of the release of skin flora from the hands as assessed after wearing a surgical glove for 3 h following surgical hand disinfection
    Protection of trial subjects
    The product used was a marketed product for use a topical hand wash
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2006
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Aged 18-65, male or female Able to communicate well with the investigator and to comply with the requirements of the entire study Healthy skin on hands without cuts or abrasions

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Method 1
    Arm description
    		 Application as per Manufacturers label instructions
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Hibiscrub
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    5ml applied rubbed for 1 min, rinse, 5ml application rubbed for 2 min, rinse, shake and dry

    Arm title
    		 Method 2
    Arm description
    		 New Application Method
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Hibiscrub
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    5ml application rubbed for 1 min, rinse 5ml application rubbed for 1 min, rinse 5ml application rubbed for 1 min, rinse, shake and dry

    Arm title
    		 Method 3
    Arm description
    		 New application method
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Hibiscrub
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Apply 5 mls of product and scrub for 1 minute, wash and rinse Apply 5 mls of product and scrub for 2 minute, wash and rinse Apply 5 mls of product and scrub for 2 minute, wash and rinse

    Arm title
    		 Reference
    Arm description
    		 As specified by the EN12791:2005 N-propanol with set instructions as the ideal efficacy results
    Arm type
    		 Reference

    Investigational medicinal product name
    PR2
    Investigational medicinal product code
    Other name
    N-Propanol
    Pharmaceutical forms
    Cutaneous liquid
    Routes of administration
    Cutaneous use
    Dosage and administration details
    3 min rub

    Number of subjects in period 1
    		Method 1 Method 2 Method 3 Reference
    Started
    20
    20
    20
    20
    Completed
    20
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Method 1
    Reporting group description
    		 Application as per Manufacturers label instructions

    Reporting group title
    Method 2
    Reporting group description
    		 New Application Method

    Reporting group title
    Method 3
    Reporting group description
    		 New application method

    Reporting group title
    Reference
    Reporting group description
    		 As specified by the EN12791:2005 N-propanol with set instructions as the ideal efficacy results

    Reporting group values
    		 Method 1 Method 2 Method 3 Reference Total
    Number of subjects
    		 20 20 20 20 20
    Age categorical
    The actual ages of the participates was not recorded so using the inclusion criteria that they will be be between 18-65
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
        Adult (18-65)
    		 20 20 20 20 20
    Gender categorical
    The data available for the gender of the trial participates is unavailable therefore data is token
    Units: Subjects
        Female
    		 10 10 10 10 10
        Male
    		 10 10 10 10 10

    End points

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    End points reporting groups
    Reporting group title
    Method 1
    Reporting group description
    		 Application as per Manufacturers label instructions

    Reporting group title
    Method 2
    Reporting group description
    		 New Application Method

    Reporting group title
    Method 3
    Reporting group description
    		 New application method

    Reporting group title
    Reference
    Reporting group description
    		 As specified by the EN12791:2005 N-propanol with set instructions as the ideal efficacy results

    Primary: Comparison of bacterial efficacy of each arm to reference product - immediate

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    End point title
    		 Comparison of bacterial efficacy of each arm to reference product - immediate
    End point description
    End point type
    Primary
    End point timeframe
    Bacterial counts taken immediately after use and 3 hours after use and compared to counts down immediately after use
    End point values
    		 Method 1 Method 2 Method 3 Reference
    Number of subjects analysed
    20
    20
    20
    20
    Units: Log reduction factor
        arithmetic mean (standard deviation)
    1.18 ( 0.727 )
    1.25 ( 0.695 )
    1.58 ( 0.934 )
    3.01 ( 1.057 )
    Statistical analysis title
    		 Reference V each method (Immediate)
    Comparison groups
    Method 2 v Method 1 v Method 3 v Reference
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 14
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Comparison of bacterial reduction factor for each application method and reference - 3 hour

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    End point title
    		 Comparison of bacterial reduction factor for each application method and reference - 3 hour
    End point description
    End point type
    Primary
    End point timeframe
    3 hours after application
    End point values
    		 Method 1 Method 2 Method 3 Reference
    Number of subjects analysed
    20
    20
    20
    20
    Units: Bacterial counts (log)
        log mean (standard deviation)
    0.94 ( 1.065 )
    0.88 ( 0.906 )
    1.10 ( 0.799 )
    2.56 ( 1.470 )
    Statistical analysis title
    		 Reference V each method (3 hour)
    Comparison groups
    Method 1 v Method 2 v Method 3 v Reference
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 24
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Subjects were monitored for the length of the trial - 4 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 20 subjects enrolled and randomized to complete all 4 arms of the study over a 4 week period

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (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
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (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: There was no non-serious AE reported due to the nature of the testing to a set standard and healthy volunteers taking part

    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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