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    Clinical Trial Results:
    Four Week Clinical Efficacy of an Ethyl Lauroyl Arginate HCl (LAE) Mouth Rinse: Effect on Gingivitis

    Summary
    EudraCT number
    		 2013-003548-22
    Trial protocol
    		 GB  
    Global end of trial date
    31 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    03 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LAEBBA0005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc.
    Sponsor organisation address
    199 Grandview Road, Skillman, NJ, United States, 08558-9418
    Public contact
    Lisa Fitzgerald, Johnson & Johnson Consumer & Personal Products Worldwide, +1 908 904-6235, Lfitzge6@its.jnj.com
    Scientific contact
    Michael C Lynch, Johnson & Johnson Consumer & Personal Products Worldwide, +1 908 904-3039, Mlynch23@its.jnj.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
    31 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this randomized, examiner-blind, single-centre, multi-site controlled, parallel-design clinical trial is to determine the efficacy of a 0.15 percentage (%) Ethyl Lauroyl Arginate HCL (LAE)-containing mouth rinse on whole-mouth mean gingival bleeding index (BI) scores as an adjunct to brushing through four weeks of use.
    Protection of trial subjects
    Ethical Conduct of the Study The study was performed in accordance with the protocol, with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines, including ICH E6 and in accordance with ISO 14155:2011. In addition, all local regulatory requirements will be followed. Subject Information and Consent All parties will ensure protection of subject personal data and will not include subject names on any forms, reports, publications, or in any other disclosures. In case of data transfer, Sponsor will maintain high standards of confidentiality and protection of subject personal data. The informed consent form in this study must be agreed to by the Sponsor and the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and must be in compliance with ICH GCP, local regulatory requirements, and legal requirements including International Organization for Standardization (ISO) 14155:2011. The Site will advise the Sponsor and the IRB/IEC if any administrative changes need to be made to the informed consent form during the course of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Mar 2014
    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: 240
    Worldwide total number of subjects
    240
    EEA total number of subjects
    240
    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)
    237
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 240 subjects were enrolled in to the study and randomized into groups. Of which, 226 subjects completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Negative Control
    Arm description
    		 Participants received placebo (5% Hydroalcohol Solution), rinse with 20ml for 30 seconds twice a day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Participants received placebo (5% Hydroalcohol Solution), rinse with 20ml for 30 seconds twice a day.

    Arm title
    		 0.2 Percent (%) Chlorhexidine (CHX)
    Arm description
    		 Participants received 0.2 % CHX containing mouthrinse, rinse mouth with water and then rinse with 10ml for 60 seconds twice a day.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Corsodyl®Mint Mouthwash
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Participants received 0.2 % CHX containing mouthrinse, rinse mouth with water and then rinse with 10ml for 60 seconds twice a day.

    Arm title
    		 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Arm description
    		 Participants received 0.15% LAE containing mouthrinse, rinse mouth with 20ml for 30 seconds twice a day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LISTERINE® Advanced Defence Gum Treatment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Participants received 0.15% LAE containing mouthrinse, rinse mouth with 20ml for 30 seconds twice a day.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The examiner and recorder were blinded to the treatment administered to subjects.
    Number of subjects in period 1
    		Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Started
    60
    60
    120
    Completed
    56
    56
    114
    Not completed
    4
    4
    6
         Consent withdrawn by subject
    -
    1
    3
         Antibiotic Use During Study
    1
    -
    -
         Adverse event, non-fatal
    1
    3
    1
         Lost to follow-up
    1
    -
    2
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Negative Control
    Reporting group description
    		 Participants received placebo (5% Hydroalcohol Solution), rinse with 20ml for 30 seconds twice a day.

    Reporting group title
    0.2 Percent (%) Chlorhexidine (CHX)
    Reporting group description
    		 Participants received 0.2 % CHX containing mouthrinse, rinse mouth with water and then rinse with 10ml for 60 seconds twice a day.

    Reporting group title
    0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Reporting group description
    		 Participants received 0.15% LAE containing mouthrinse, rinse mouth with 20ml for 30 seconds twice a day.

    Reporting group values
    		 Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE) Total
    Number of subjects
    		 60 60 120 240
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 58 60 119 237
        From 65 to 84 years
    		 2 0 1 3
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.6 ( 11.6 ) 38.5 ( 10.83 ) 38.6 ( 10.37 ) -
    Title for Gender
    Units: subjects
        Female
    		 44 50 91 185
        Male
    		 16 10 29 55

    End points

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    End points reporting groups
    Reporting group title
    Negative Control
    Reporting group description
    		 Participants received placebo (5% Hydroalcohol Solution), rinse with 20ml for 30 seconds twice a day.

    Reporting group title
    0.2 Percent (%) Chlorhexidine (CHX)
    Reporting group description
    		 Participants received 0.2 % CHX containing mouthrinse, rinse mouth with water and then rinse with 10ml for 60 seconds twice a day.

    Reporting group title
    0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Reporting group description
    		 Participants received 0.15% LAE containing mouthrinse, rinse mouth with 20ml for 30 seconds twice a day.

    Primary: Whole-Mouth Mean Bleeding Index (BI) at Week 4

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    End point title
    		 Whole-Mouth Mean Bleeding Index (BI) at Week 4
    End point description
    Each of four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded on scale 0 to 2. Where, 0 =Absence of bleeding after 30 seconds, 1 = Bleeding after 30 seconds and 2 = Immediate bleeding.
    End point type
    Primary
    End point timeframe
    At Week 4
    End point values
    		 Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Number of subjects analysed
    56
    56
    114
    Units: units on scale
        arithmetic mean (standard deviation)
    0.161 ( 0.1464 )
    0.076 ( 0.0977 )
    0.127 ( 0.1851 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Negative Control v 0.2 Percent (%) Chlorhexidine (CHX)
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1364
         upper limit
    		 -0.0359
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Negative Control v 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.108
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0789
         upper limit
    		 0.0079
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE) v 0.2 Percent (%) Chlorhexidine (CHX)
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.663
    Method
    		 ANCOVA
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.0429
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.018225

    Secondary: Whole-Mouth Mean Modified Gingival Index (MGI)

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    End point title
    		 Whole-Mouth Mean Modified Gingival Index (MGI)
    End point description
    The MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth on scale of 0 to 4. Where, 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit, 2 = Mild inflammation of the entire gingival unit, 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit. Here "N" and 'n' signifies those who were evaluable for this outcome measure and at given time point respectively.
    End point type
    Secondary
    End point timeframe
    At Week 1, 2 and 4
    End point values
    		 Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Number of subjects analysed
    58
    58
    117
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 1 (n=56, 58, 117)
    2.012 ( 0.115 )
    1.962 ( 0.1328 )
    2.014 ( 0.1177 )
        Week 2 (n= 58, 55, 113)
    1.796 ( 0.3663 )
    1.605 ( 0.4642 )
    1.751 ( 0.3573 )
        Week 4 (n= 56, 56, 114)
    1.344 ( 0.662 )
    1.106 ( 0.7245 )
    1.188 ( 0.7477 )
    No statistical analyses for this end point

    Secondary: Whole-Mouth Mean Bleeding Index (BI) at Weeks 1 and 2

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    End point title
    		 Whole-Mouth Mean Bleeding Index (BI) at Weeks 1 and 2
    End point description
    Each of four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded on scale 0 to 2. Where, 0 =Absence of bleeding after 30 seconds, 1 = Bleeding after 30 seconds and 2 = Immediate bleeding. Here "N" and 'n' signifies those who were evaluable for this outcome measure and at given time point respectively.
    End point type
    Secondary
    End point timeframe
    At Week 1 and 2
    End point values
    		 Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Number of subjects analysed
    58
    58
    117
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 1 (n= 56, 58, 117)
    0.21 ( 0.1534 )
    0.136 ( 0.0966 )
    0.201 ( 0.1616 )
        Week 2 (n= 58, 55, 113)
    0.197 ( 0.1542 )
    0.096 ( 0.1335 )
    0.171 ( 0.1951 )
    No statistical analyses for this end point

    Secondary: Whole-Mouth Mean Extrinsic Stain Index Composite Score

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    End point title
    		 Whole-Mouth Mean Extrinsic Stain Index Composite Score
    End point description
    The mean stain score per subject is determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. Here "N" and 'n' signifies those who were evaluable for this outcome measure and at given time point respectively.
    End point type
    Secondary
    End point timeframe
    At Week 2 and 4
    End point values
    		 Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Number of subjects analysed
    58
    58
    117
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 2 (n= 58, 55, 113)
    0.29 ( 0.442 )
    0.836 ( 0.9736 )
    0.568 ( 0.8089 )
        Week 4 (n= 56, 56, 114)
    0.454 ( 0.6245 )
    1.707 ( 1.2294 )
    1.036 ( 1.1107 )
    No statistical analyses for this end point

    Secondary: Whole-Mouth Mean Plaque Index (PI)

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    End point title
    		 Whole-Mouth Mean Plaque Index (PI)
    End point description
    The PI on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing on scale of 0 to 5. Where, 0 = No Plaque; 1 = Separate flecks or discontinuous band of plaque around the gingival (cervical) margin; 2 = Thin (up to 1mm), continuous band of plaque at the gingival margin; 3 = Band of plaque wider than 1mm but less than 1/3 of the surface; 4 = Plaque covering 1/3 or more, but less than 2/3 of the surface; 5 = Plaque covering 2/3 or more of the surface. Here "N" and 'n' signifies those who were evaluable for this outcome measure and at given time point respectively.
    End point type
    Secondary
    End point timeframe
    At Week 1, 2 and 4
    End point values
    		 Negative Control 0.2 Percent (%) Chlorhexidine (CHX) 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Number of subjects analysed
    58
    58
    117
    Units: units on scale
    arithmetic mean (standard deviation)
        Week 1 (n= 56, 58, 117)
    2.237 ( 0.3796 )
    1.292 ( 0.519 )
    1.639 ( 0.5589 )
        Week 2 (n= 57, 55, 113)
    2.309 ( 0.3422 )
    1.209 ( 0.6316 )
    1.61 ( 0.5825 )
        Week 4 (n= 56, 56, 114)
    2.311 ( 0.4004 )
    1.25 ( 0.7809 )
    1.704 ( 0.5857 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to week 4
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Negative Control
    Reporting group description
    		 Participants received placebo (5% Hydroalcohol Solution), rinse with 20ml for 30 seconds twice a day.

    Reporting group title
    0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE)
    Reporting group description
    		 Participants received 0.15% LAE containing mouthrinse, rinse mouth with 20ml for 30 seconds twice a day.

    Reporting group title
    0.2 Percent (%) Chlorhexidine (CHX)
    Reporting group description
    		 Participants received 0.2 % CHX containing mouthrinse, rinse mouth with water and then rinse with 10ml for 60 seconds twice a day.

    Serious adverse events
    		 Negative Control 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE) 0.2 Percent (%) Chlorhexidine (CHX)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 120 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Negative Control 0.15 Percent (%) Ethyl Lauroyl Arginate HCL (LAE) 0.2 Percent (%) Chlorhexidine (CHX)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 60 (20.00%)
    14 / 120 (11.67%)
    15 / 60 (25.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 60 (6.67%)
    6 / 120 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    4
    6
    2
    Gastrointestinal disorders
    Tongue Discolouration
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 120 (3.33%)
    10 / 60 (16.67%)
         occurrences all number
    1
    4
    10
    Infections and infestations
    Oral Herpes
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 120 (2.50%)
    2 / 60 (3.33%)
         occurrences all number
    3
    3
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 120 (1.67%)
    3 / 60 (5.00%)
         occurrences all number
    4
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2013
    The overall reason for the amendment was to make necessary changes to eliminate apparent immediate hazards to the subjects.

    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
    For support, Contact us.
    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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