Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines

    Summary
    EudraCT number
    		 2010-019085-82
    Trial protocol
    		 DE  
    Global end of trial date
    27 Sep 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    11 Mar 2016
    First version publication date
    12 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review and correction.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Y-52-52120-146
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Innovation
    Sponsor organisation address
    5 Avenue du Les Ulis Cedex, Canada, France, 91940
    Public contact
    Medical Director, Ipsen Innovation, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Innovation, clinical.trials@ipsen.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
    13 Dec 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.
    Protection of trial subjects
    The study and the archiving of essential documents were performed in compliance with Good Clinical Practice (GCP) and in accordance with the Declaration of Helsinki. The present study was designed to assess the efficacy and safety of different doses of the new formulation, Dysport NG (20 Units (U), 50 U and 75 U), when used for the same indication. Additionally, the study aimed to assess the relative efficacy and safety of the different doses of this new formulation compared with the optimal dose of Dysport (50 U) when used to improve the appearance of moderate to severe glabellar lines.
    Background therapy
    		 -
    Evidence for comparator
    		 The study aimed to assess the relative efficacy and safety of the different doses of new formulation [Dysport NG (20 Units (U), 50 U and 75 U)] compared with the optimal dose of Dysport (50 U) when used to improve the appearance of moderate to severe glabellar lines.
    Actual start date of recruitment
    30 Mar 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 85
    Country: Number of subjects enrolled
    France: 91
    Worldwide total number of subjects
    176
    EEA total number of subjects
    176
    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)
    176
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study was performed as a multicentre study at eight investigational sites in France and Germany. Date of first enrolment: 30-Mar-2011 and Date of last completed: 27-Sep-2011.

    Pre-assignment
    Screening details
    		 A total of 178 patients were screened. 2 patient did not meet the entry criteria. 176 patients were randomized.Patients were radomized into 5 groups.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    On Day 1 (Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) The placebo was supplied for administration as a liquid in a PFS containing only the excipients of Dysport NG, i.e. without the toxin. The placebo was to be prepared in the same way as Dysport NG

    Arm title
    		 Dysport NG 20 U
    Arm description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) Ready to Use (RU) Next Generation (NG)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DYSPORT NG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Arm title
    		 Dysport NG 50 U
    Arm description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DYSPORT NG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Arm title
    		 Dysport NG 75 U
    Arm description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DYSPORT NG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Arm title
    		 Dysport 50 U
    Arm description
    		 Botulinum type A toxin (Azzalure®), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azzalure®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum type A toxin (Azzalure®), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Number of subjects in period 1
    		Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Started
    35
    36
    35
    35
    35
    Completed
    34
    36
    35
    34
    35
    Not completed
    1
    0
    0
    1
    0
         Lost to follow-up
    1
    -
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group title
    Dysport NG 20 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) Ready to Use (RU) Next Generation (NG)

    Reporting group title
    Dysport NG 50 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group title
    Dysport NG 75 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group title
    Dysport 50 U
    Reporting group description
    		 Botulinum type A toxin (Azzalure®), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U Total
    Number of subjects
    		 35 36 35 35 35 176
    Age categorical
    Units: Subjects
        Age 30 - 60 years
    		 35 36 35 35 35 176
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.8 ± 6.4 46.7 ± 8.4 48.1 ± 6.9 47.9 ± 6 47 ± 6.6 -
    Gender categorical
    Units: Subjects
        Female
    		 35 36 35 35 35 176
        Male
    		 0 0 0 0 0 0
    Race
    Units: Subjects
        Caucasian/White
    		 35 36 35 35 35 176
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 0 2 0 2 1 5
        Not Hispanic/Latino
    		 35 34 35 33 34 171

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group title
    Dysport NG 20 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle) Ready to Use (RU) Next Generation (NG)

    Reporting group title
    Dysport NG 50 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group title
    Dysport NG 75 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Reporting group title
    Dysport 50 U
    Reporting group description
    		 Botulinum type A toxin (Azzalure®), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

    Primary: Percentage of Subjects as Responders in the ILA (Using Validated 4 point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown

    		 Close Top of page
    End point title
    		 Percentage of Subjects as Responders in the ILA (Using Validated 4 point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown [1]
    End point description
    Investigator’s live assessment (ILA), subject’s self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2 Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N’=number of subjects with assessment
    End point type
    Primary
    End point timeframe
    Day 29
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The primary objectives was to assess the relative safety and efficacy of Dysport NG compared to Placebo
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U
    Number of subjects analysed
    34
    36
    35
    33
    Units: percentage of subjects
    number (not applicable)
        ILA (N’=34,36,35,33)
    0
    88.9
    91.4
    87.9
        SSA (N’=34,36,35,33)
    2.9
    91.7
    85.7
    81.8
    Statistical analysis title
    		 ILA - Dysport NG 20 U Vs Placebo
    Comparison groups
    Placebo v Dysport NG 20 U
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 SSA - Dysport NG 20 U Vs Placebo
    Comparison groups
    Placebo v Dysport NG 20 U
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 ILA - Dysport NG 50 U Vs Placebo
    Comparison groups
    Placebo v Dysport NG 50 U
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 ILA - Dysport NG 75 U Vs Placebo
    Comparison groups
    Dysport NG 75 U v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 SSA - Dysport NG 50 U Vs Placebo
    Comparison groups
    Placebo v Dysport NG 50 U
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 SSA - Dysport NG 75 U Vs Placebo
    Comparison groups
    Placebo v Dysport NG 75 U
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Percentage of subjects as assessed as responders, by both Investigator's live assessment and the subject's self-assessment at maximum frown

    		 Close Top of page
    End point title
    		 Percentage of subjects as assessed as responders, by both Investigator's live assessment and the subject's self-assessment at maximum frown
    End point description
    A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2. ITT Population; Day 29 (N'=34,36,35,33,35); N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    34
    36
    35
    33
    35
    Units: percentage of subjects
        number (not applicable)
    0
    86.1
    85.7
    81.8
    77.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment

    		 Close Top of page
    End point title
    		 Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment [2]
    End point description
    ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 57, 85 and Day 113
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport NG compared to Placebo
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U
    Number of subjects analysed
    34
    36
    35
    35
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 8 (N’=34,36,35,35)
    0
    77.8
    80
    82.9
        ILA: Day 15 (N’=33,36,35,35)
    3
    80.6
    94.3
    91.4
        ILA: Day 57 (N’=33,35,34,34)
    0
    77.1
    79.4
    82.4
        ILA: Day 85 (N’=34,33,34,32)
    0
    48.5
    58.8
    75
        ILA: Day 113 (N’=34,36,35,34)
    0
    22.2
    42.9
    55.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects as responders at maximum frown as measured by the subject’s self-assessment

    		 Close Top of page
    End point title
    		 Percentage of subjects as responders at maximum frown as measured by the subject’s self-assessment [3]
    End point description
    ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 57, 85 and 113
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport NG compared to Placebo
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U
    Number of subjects analysed
    34
    36
    35
    35
    Units: percentage of subjects
    number (not applicable)
        SSA: Day 8 (N’=34,36,35,35)
    2.9
    66.7
    65.7
    74.3
        SSA: Day 15 (N’=33,36,35,35)
    3
    80.6
    82.9
    80
        SSA: Day 57 (N’=34,35,34,34)
    0
    80
    67.6
    82.4
        SSA: Day 85 (N’=34,35,34,32)
    0
    57.1
    47.1
    62.5
        SSA: Day 113 (N’=34,36,35,34)
    0
    36.1
    34.3
    52.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects assessed as responders, by both the Investigator’s live assessment and the subject’s self-assessment at maximum frown

    		 Close Top of page
    End point title
    		 Percentage of subjects assessed as responders, by both the Investigator’s live assessment and the subject’s self-assessment at maximum frown
    End point description
    ITT Population; N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 57, 85 and 113
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    34
    36
    35
    35
    35
    Units: percentage of subjects
    number (not applicable)
        Day 8 (N’=34,36,35,35,35)
    0
    61.1
    62.9
    74.3
    51.4
        Day 15 (N’=34,36,35,35,34)
    0
    75
    82.9
    80
    67.6
        Day 57 (N’=34,35,34,34,34)
    0
    74.3
    67.6
    79.4
    64.7
        Day 85 (N’=34,33,34,32,34)
    0
    42.4
    44.1
    62.5
    38.2
        Day 113 (N’=34,36,35,34,35)
    0
    19.4
    34.3
    41.2
    25.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects as responders at rest as measured by the Investigator's live assessment

    		 Close Top of page
    End point title
    		 Percentage of subjects as responders at rest as measured by the Investigator's live assessment [4]
    End point description
    A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2. ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit;
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport NG compared to Placebo
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U
    Number of subjects analysed
    18
    17
    13
    14
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 8 (N’=18,17,13,14)
    11.1
    70.6
    76.9
    71.4
        ILA: Day 15 (N’=18,17,13,14)
    11.1
    70.6
    92.3
    78.6
        ILA: Day 29 (N’=18,17,13,14)
    5.6
    82.4
    76.9
    85.7
        ILA: Day 57 (N’=17,16,13,14)
    11.8
    81.3
    76.9
    78.6
        ILA: Day 85 (N’=18,17,12,14)
    5.6
    82.4
    75
    64.3
        ILA: Day 113 (N’=18,17,13,14)
    11.1
    52.9
    53.8
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects as responders at maximum frown on Day 29 who remain responders

    		 Close Top of page
    End point title
    		 Percentage of subjects as responders at maximum frown on Day 29 who remain responders
    End point description
    A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2. ITT Population; N’=number of responders at Day 29
    End point type
    Secondary
    End point timeframe
    Day 113
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    1
    33
    32
    29
    29
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 29 (N’=0,32,32,29,27)
    0
    25
    46.9
    65.5
    40.7
        SSA: Day 29 (N’=1,33,30,27,29)
    0
    36.4
    40
    63
    34.5
    No statistical analyses for this end point

    Secondary: Percentage of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown as measured by the Investigator's live assessment

    		 Close Top of page
    End point title
    		 Percentage of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown as measured by the Investigator's live assessment
    End point description
    A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    34
    36
    35
    35
    35
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 8 (N’=34,36,35,35,35)
    0
    30.6
    45.7
    45.7
    31.4
        ILA: Day 15 (N’=33,36,35,35,34)
    0
    50
    62.9
    57.1
    50
        ILA: Day 29 (N’=34,36,35,33,35)
    0
    55.6
    68.6
    63.6
    57.1
        ILA: Day 57 (N’=33,35,34,34,34)
    0
    34.3
    47.1
    44.1
    41.2
        ILA: Day 85 (N’=34,33,34,32,34)
    0
    24.2
    29.4
    31.3
    26.5
        ILA: Day 113 (N’=34,36,35,34,35)
    0
    13.9
    14.3
    20.6
    8.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects with a reduction of two or more grades in the severity of glabellar lines at rest as measured by the Investigator's live assessment

    		 Close Top of page
    End point title
    		 Percentage of subjects with a reduction of two or more grades in the severity of glabellar lines at rest as measured by the Investigator's live assessment
    End point description
    A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment. ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    18
    17
    13
    14
    19
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 8 (N’=18,17,13,14,19)
    5.6
    5.9
    23.1
    21.4
    10.5
        ILA: Day 15 (N’=18,17,13,14,18)
    5.6
    17.6
    23.1
    21.4
    16.7
        ILA: Day 29 (N’=18,17,13,14,19)
    0
    11.8
    23.1
    28.6
    21.1
        ILA: Day 57 (N’=17,16,13,14,19)
    5.9
    18.8
    15.4
    21.4
    15.8
        ILA: Day 85 (N’=18,17,12,14,19)
    0
    17.6
    16.7
    7.1
    15.8
        ILA: Day 113 (N’=18,17,13,14,19)
    0
    5.9
    23.1
    14.3
    5.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown as measured by the subject's self-assessment

    		 Close Top of page
    End point title
    		 Percentage of subjects with a reduction of two or more grades in the severity of glabellar lines at maximum frown as measured by the subject's self-assessment
    End point description
    A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment. ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    34
    36
    35
    35
    35
    Units: percentage of subjects
    number (not applicable)
        SSA: Day 8 (N’=34,36,35,35,35)
    0
    25
    42.9
    40
    34.3
        SSA: Day 15 (N’=33,36,35,35,34)
    0
    52.8
    57.1
    54.3
    47.1
        SSA: Day 29 (N’=34,36,35,33,35)
    0
    52.8
    60
    57.6
    57.1
        SSA: Day 57 (N’=34,35,34,34,34)
    0
    40
    52.9
    44.1
    47.1
        SSA: Day 85 (N’=34,35,34,32,34)
    0
    28.6
    29.4
    31.3
    29.4
        SSA: Day 113 (N’=34,36,35,34,35)
    0
    8.3
    22.9
    11.8
    17.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects as Responders, as Measured by the Investigator’s Live Assessment at Maximum Frown (Comparison with Dysport 50 U)

    		 Close Top of page
    End point title
    		 Percentage of subjects as Responders, as Measured by the Investigator’s Live Assessment at Maximum Frown (Comparison with Dysport 50 U) [5]
    End point description
    ITT Population; N’=number of subjects with assessment
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport NG compared to Dysport U
    End point values
    		 Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    36
    35
    35
    35
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 8 (N’=36,35,35,35)
    77.8
    80
    82.9
    57.1
        ILA: Day 15 (N’=36,35,35,34)
    80.6
    94.3
    91.4
    73.5
        ILA: Day 29 (N’=36,35,33,35)
    88.9
    91.4
    87.9
    77.1
        ILA: Day 57 (N’=35,34,34,34)
    77.1
    79.4
    82.4
    70.6
        ILA: Day 85 (N’=33,34,32,34)
    48.5
    58.8
    75
    52.9
        ILA: Day 113 (N’=36,35,34,35)
    22.2
    42.9
    55.9
    31.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects as Responders, as Measured by the Subject’s Self assessment at Maximum Frown (Comparison with Dysport 50 U)

    		 Close Top of page
    End point title
    		 Percentage of subjects as Responders, as Measured by the Subject’s Self assessment at Maximum Frown (Comparison with Dysport 50 U) [6]
    End point description
    ITT Population; N’=number of subjects with assessment
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport NG compared to Dysport U
    End point values
    		 Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    36
    35
    35
    35
    Units: percentage of subjects
    number (not applicable)
        SSA: Day 8 (N’=36,35,35,35)
    66.7
    65.7
    74.3
    57.1
        SSA: Day 15 (N’=36,35,35,34)
    80.6
    82.9
    80
    73.5
        SSA: Day 29 (N’=36,35,33,35)
    91.7
    85.7
    81.8
    82.9
        SSA: Day 57 (N’=35,34,34,34)
    80
    67.6
    82.4
    73.5
        SSA: Day 85 (N’=35,34,32,34)
    57.1
    47.1
    62.5
    41.2
        SSA: Day 113 (N’=36,35,34,35)
    36.1
    34.3
    52.9
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects as Responders, as Measured by the Investigator’s Live Assessment at Rest (Comparison with Dysport 50 U)

    		 Close Top of page
    End point title
    		 Percentage of subjects as Responders, as Measured by the Investigator’s Live Assessment at Rest (Comparison with Dysport 50 U) [7]
    End point description
    ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit
    End point type
    Secondary
    End point timeframe
    Days 8, 15, 29, 57, 85 and 113
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport NG compared to Dysport U
    End point values
    		 Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    17
    13
    14
    19
    Units: percentage of subjects
    number (not applicable)
        ILA: Day 8 (N’=17,13,14,19)
    70.6
    76.9
    71.4
    63.2
        ILA: Day 15 (N’=17,13,14,18)
    70.6
    92.3
    78.6
    72.2
        ILA: Day 29 (N’=17,13,14,19)
    82.4
    76.9
    85.7
    84.2
        ILA: Day 57 (N’=16,13,14,19)
    81.3
    76.9
    78.6
    84.2
        ILA: Day 85 (N’=17,12,14,19)
    82.4
    75
    64.3
    68.4
        ILA: Day 113 (N’=17,13,14,19)
    52.9
    53.8
    57.1
    52.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects as Responders at Day 29 by the Investigator’s Live Assessment and by Subject’s Self assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)

    		 Close Top of page
    End point title
    		 Percentage of subjects as Responders at Day 29 by the Investigator’s Live Assessment and by Subject’s Self assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity) [8]
    End point description
    ITT Population; N’=number of subjects with an assessment at Day 29
    End point type
    Secondary
    End point timeframe
    Day 29
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The secondary objectives were to assess the relative safety and efficacy of Dysport 50 U compared to Placebo
    End point values
    		 Placebo Dysport 50 U
    Number of subjects analysed
    34
    35
    Units: percentage of subjects
    number (not applicable)
        ILA: (N’=34,35)
    0
    77.1
        SSA: (N’=34,35)
    2.9
    82.9
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects Reporting at least one Treatment Emergent Adverse Event during the study

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting at least one Treatment Emergent Adverse Event during the study
    End point description
    Treatment Emergent Adverse Event (TEAE) Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected
    End point type
    Other pre-specified
    End point timeframe
    Up to Day 113 (±3 days)
    End point values
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Number of subjects analysed
    35
    36
    35
    35
    35
    Units: participants
    number (not applicable)
        TEAE
    12
    15
    10
    11
    10
        Severe TEAE
    0
    1
    0
    0
    0
        Related TEAE
    5
    6
    4
    4
    2
        Related and severe TEAE
    0
    0
    0
    0
    0
        TEAE leading to withdrawal
    0
    0
    0
    0
    0
        TEAE leading to death
    0
    0
    0
    0
    0
        Serious Adverse Event (SAE)
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 113 (±3 days)
    Adverse event reporting additional description
    Serious Adverse Event (SAE) Treatment Emergent Adverse Event (TEAE)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Intramuscular injections on Day 1 (0.05 mL per injection) (single treatment cycle)

    Reporting group title
    Dysport NG 20 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (0.05 mL per injection) (single treatment cycle)

    Reporting group title
    Dysport NG 50 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (0.05 mL per injection) (single treatment cycle)

    Reporting group title
    Dysport NG 75 U
    Reporting group description
    		 Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (0.05 mL per injection) (single treatment cycle)

    Reporting group title
    Dysport 50 U
    Reporting group description
    		 Botulinum type A toxin ((Azzalure®), Intramuscular injections on Day 1 (0.05 mL per injection) (single treatment cycle)

    Serious adverse events
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Dysport NG 20 U Dysport NG 50 U Dysport NG 75 U Dysport 50 U
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 35 (34.29%)
    14 / 36 (38.89%)
    10 / 35 (28.57%)
    11 / 35 (31.43%)
    10 / 35 (28.57%)
    Vascular disorders
    Venous thrombosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    1
    2
    1
    2
    1
    Injection site discomfort
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injection site anaesthesia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    Laparoscopy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    1
    Road traffic accident
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    Animal bite
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Heat stroke
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Laceration
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Periorbital haematoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Face injury
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 35 (11.43%)
    2 / 36 (5.56%)
    3 / 35 (8.57%)
    2 / 35 (5.71%)
    3 / 35 (8.57%)
         occurrences all number
    4
    2
    3
    3
    3
    Migraine
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    0
    1
    Syncope
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    1
    Eyelid ptosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Keratitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    0
    0
    2
    Periarthritis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
         occurrences all number
    4
    0
    1
    1
    3
    Influenza
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Eczema infected
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2010
    Addition of contact information for the Coordinating Investigator on the cover page. Reference to Azzalure Summary of Product Characteristics (SmPC) rather than the Dysport NG Investigator’s Brochure (IB) for the assessment of expectedness. Additional photographs to be used for each grade in the photographic scale. Minor consistency changes.
    01 Feb 2011
    The changes to the protocol were the result of feedback from Investigator training meetings. The following changes were agreed to by the Investigators and study team members: Maximum age for inclusion in the study was increased to 60 years. Exclusion criteria were modified to reflect specific time points wherein subjects having received dermatological procedures would be excluded from the study.

    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.

    European Medicines Agency © 1995-Fri Apr 19 07:21:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA