Glabellar Frown Lines
Conditions
Brief summary
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.
Interventions
BIOLOGICALBotulinum toxin type A
I.M. (in the muscle) injection on day 1 (single treatment cycle)
DRUGPlacebo
I.M. on day 1 (single treatment cycle)
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female between 30 - 60 years of age * Moderate to severe vertical glabellar lines at maximum frown at baseline
Exclusion criteria
* Silicone injections into the upper face * Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months * Any planned facial cosmetic surgery during the study period * A history of ablative skin resurfacing of the area to be treated during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | Day 29 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | Days 8, 15, 29, 57, 85 and 113 | 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. |
| Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 29 | 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. |
| Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | Days 8, 15, 57, 85 and 113 | — |
| Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | Days 8, 15, 57, 85 and 113 | — |
| Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Days 8, 15, 57, 85 and 113 | — |
| Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | Day 113 | 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. |
| 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 | Days 8, 15, 29, 57, 85 and 113 | 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. |
| 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 | Days 8, 15, 29, 57, 85 and 113 | 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. |
| Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | Days 8, 15, 29, 57, 85 and 113 | — |
| Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | Days 8, 15, 29, 57, 85 and 113 | — |
| Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | Days 8, 15, 29, 57, 85 and 113 | — |
| 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) | Day 29 | — |
| 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 | Days 8, 15, 29, 57, 85 and 113 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Up to Day 113 (±3 days) | Treatment Emergent Adverse Event (TEAE) |
Countries
France, Germany
Participant flow
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 details
A total of 178 patients were screened. 2 patient did not meet the entry criteria. 176 patients were randomized.Patients were randomized into 5 groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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) | 35 |
| Dysport NG 20 U 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) | 36 |
| Dysport NG 50 U 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) | 35 |
| Dysport NG 75 U 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) | 35 |
| Dysport 50 U 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) | 35 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Dysport NG 20 U | Dysport NG 50 U | Dysport NG 75 U | Dysport 50 U | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 6.4 | 46.7 years STANDARD_DEVIATION 8.4 | 48.1 years STANDARD_DEVIATION 6.9 | 47.9 years STANDARD_DEVIATION 6 | 47.0 years STANDARD_DEVIATION 6.6 | 47.3 years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized Hispanic or Latino | 0 participants | 2 participants | 0 participants | 2 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 35 participants | 34 participants | 35 participants | 33 participants | 34 participants | 171 participants |
| Race/Ethnicity, Customized White | 35 participants | 36 participants | 35 participants | 35 participants | 35 participants | 176 participants |
| Sex/Gender, Customized Female | 35 participants | 36 participants | 35 participants | 35 participants | 35 participants | 176 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 35 | 14 / 36 | 10 / 35 | 11 / 35 | 10 / 35 |
| serious Total, serious adverse events | 0 / 35 | 1 / 36 | 0 / 35 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
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.
Time frame: Day 29
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | ILA (N'=34,36,35,33) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | SSA (N'=34,36,35,33) | 2.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | SSA (N'=34,36,35,33) | 91.7 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | ILA (N'=34,36,35,33) | 88.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | ILA (N'=34,36,35,33) | 91.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | SSA (N'=34,36,35,33) | 85.7 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | ILA (N'=34,36,35,33) | 87.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown | SSA (N'=34,36,35,33) | 81.8 percentage of subjects |
Comparison: ILA - Dysport NG 20 U Vs Placebop-value: <0.0001Chi-squared
Comparison: ILA - Dysport NG 50 U Vs Placebop-value: <0.0001Chi-squared
Comparison: ILA - Dysport NG 75 U Vs Placebop-value: <0.0001Chi-squared
Comparison: SSA - Dysport NG 20 U Vs Placebop-value: <0.0001Chi-squared
Comparison: SSA - Dysport NG 50 U Vs Placebop-value: <0.0001Chi-squared
Comparison: SSA - Dysport NG 75 U Vs Placebop-value: <0.0001Chi-squared
Secondary
Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
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.
Time frame: Day 29
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | 0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | 86.1 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | 85.7 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | 81.8 percentage of subjects |
| Dysport 50 U | Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | 77.1 percentage of subjects |
Secondary
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: ITT Population; N'=number of subjects with assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 8 (N'=36,35,35,35) | 77.8 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 15 (N'=36,35,35,34) | 80.6 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 57 (N'=35,34,34,34) | 77.1 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 113 (N'=36,35,34,35) | 22.2 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 85 (N'=33,34,32,34) | 48.5 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 29 (N'=36,35,33,35) | 88.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 85 (N'=33,34,32,34) | 58.8 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 57 (N'=35,34,34,34) | 79.4 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 8 (N'=36,35,35,35) | 80.0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 113 (N'=36,35,34,35) | 42.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 29 (N'=36,35,33,35) | 91.4 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 15 (N'=36,35,35,34) | 94.3 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 85 (N'=33,34,32,34) | 75.0 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 8 (N'=36,35,35,35) | 82.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 15 (N'=36,35,35,34) | 91.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 29 (N'=36,35,33,35) | 87.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 57 (N'=35,34,34,34) | 82.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 113 (N'=36,35,34,35) | 55.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 57 (N'=35,34,34,34) | 70.6 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 15 (N'=36,35,35,34) | 73.5 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 8 (N'=36,35,35,35) | 57.1 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 85 (N'=33,34,32,34) | 52.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 29 (N'=36,35,33,35) | 77.1 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) | ILA: Day 113 (N'=36,35,34,35) | 31.4 percentage of subjects |
Secondary
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 8 (N'=17,13,14,19) | 70.6 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 15 (N'=17,13,14,18) | 70.6 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 29 (N'=17,13,14,19) | 82.4 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 57 (N'=16,13,14,19) | 81.3 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 85 (N'=17,12,14,19) | 82.4 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 113 (N'=17,13,14,19) | 52.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 113 (N'=17,13,14,19) | 53.8 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 57 (N'=16,13,14,19) | 76.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 8 (N'=17,13,14,19) | 76.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 29 (N'=17,13,14,19) | 76.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 15 (N'=17,13,14,18) | 92.3 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 85 (N'=17,12,14,19) | 75.0 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 15 (N'=17,13,14,18) | 78.6 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 29 (N'=17,13,14,19) | 85.7 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 57 (N'=16,13,14,19) | 78.6 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 113 (N'=17,13,14,19) | 57.1 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 85 (N'=17,12,14,19) | 64.3 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 8 (N'=17,13,14,19) | 71.4 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 85 (N'=17,12,14,19) | 68.4 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 113 (N'=17,13,14,19) | 52.6 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 15 (N'=17,13,14,18) | 72.2 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 57 (N'=16,13,14,19) | 84.2 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 8 (N'=17,13,14,19) | 63.2 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) | ILA: Day 29 (N'=17,13,14,19) | 84.2 percentage of subjects |
Secondary
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: ITT Population; N'=number of subjects with assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 8 (N'=36,35,35,35) | 66.7 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 15 (N'=36,35,35,34) | 80.6 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 29 (N'=36,35,33,35) | 91.7 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 57 (N'=35,34,34,34) | 80.0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 85 (N'=35,34,32,34) | 57.1 percentage of subjects |
| Placebo | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 113 (N'=36,35,34,35) | 36.1 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 113 (N'=36,35,34,35) | 34.3 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 57 (N'=35,34,34,34) | 67.6 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 8 (N'=36,35,35,35) | 65.7 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 29 (N'=36,35,33,35) | 85.7 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 15 (N'=36,35,35,34) | 82.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 85 (N'=35,34,32,34) | 47.1 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 15 (N'=36,35,35,34) | 80.0 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 29 (N'=36,35,33,35) | 81.8 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 57 (N'=35,34,34,34) | 82.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 113 (N'=36,35,34,35) | 52.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 85 (N'=35,34,32,34) | 62.5 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 8 (N'=36,35,35,35) | 74.3 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 85 (N'=35,34,32,34) | 41.2 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 113 (N'=36,35,34,35) | 28.6 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 15 (N'=36,35,35,34) | 73.5 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 57 (N'=35,34,34,34) | 73.5 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 8 (N'=36,35,35,35) | 57.1 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) | SSA: Day 29 (N'=36,35,33,35) | 82.9 percentage of subjects |
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)
Time frame: Day 29
Population: ITT Population; N'=number of subjects with an assessment at Day 29
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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) | ILA: (N'=34,35) | 0 percentage of subjects |
| Placebo | 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) | SSA: (N'=34,35) | 2.9 percentage of subjects |
| Dysport NG 20 U | 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) | ILA: (N'=34,35) | 77.1 percentage of subjects |
| Dysport NG 20 U | 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) | SSA: (N'=34,35) | 82.9 percentage of subjects |
Secondary
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
Time frame: Days 8, 15, 57, 85 and 113
Population: ITT Population; N'=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=34,33,34,32) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=33,36,35,35) | 3.0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=34,36,35,34) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=33,35,34,34) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=34,36,35,35) | 0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=33,35,34,34) | 77.1 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=34,33,34,32) | 48.5 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=34,36,35,34) | 22.2 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=33,36,35,35) | 80.6 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=34,36,35,35) | 77.8 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=33,35,34,34) | 79.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=34,36,35,35) | 80.0 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=33,36,35,35) | 94.3 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=34,33,34,32) | 58.8 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=34,36,35,34) | 42.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=34,33,34,32) | 75.0 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=33,36,35,35) | 91.4 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=34,36,35,35) | 82.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=33,35,34,34) | 82.4 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=34,36,35,34) | 55.9 percentage of subjects |
Secondary
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
Time frame: Days 8, 15, 57, 85 and 113
Population: ITT Population; N'= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 85 (N'=34,35,34,32) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 15 (N'=33,36,35,35) | 3.0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 113 (N'=34,36,35,34) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 57 (N'=34,35,34,34) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 8 (N'=34,36,35,35) | 2.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 57 (N'=34,35,34,34) | 80.0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 85 (N'=34,35,34,32) | 57.1 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 113 (N'=34,36,35,34) | 36.1 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 15 (N'=33,36,35,35) | 80.6 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 8 (N'=34,36,35,35) | 66.7 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 57 (N'=34,35,34,34) | 67.6 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 8 (N'=34,36,35,35) | 65.7 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 15 (N'=33,36,35,35) | 82.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 85 (N'=34,35,34,32) | 47.1 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 113 (N'=34,36,35,34) | 34.3 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 85 (N'=34,35,34,32) | 62.5 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 15 (N'=33,36,35,35) | 80.0 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 8 (N'=34,36,35,35) | 74.3 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 57 (N'=34,35,34,34) | 82.4 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. | SSA: Day 113 (N'=34,36,35,34) | 52.9 percentage of subjects |
Secondary
Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
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.
Time frame: Day 113
Population: ITT Population; N'=number of responders at Day 29
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | ILA: Day 29 (N'=0,32,32,29,27) | 0 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | SSA: Day 29 (N'=1,33,30,27,29) | 0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | ILA: Day 29 (N'=0,32,32,29,27) | 25.0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | SSA: Day 29 (N'=1,33,30,27,29) | 36.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | ILA: Day 29 (N'=0,32,32,29,27) | 46.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | SSA: Day 29 (N'=1,33,30,27,29) | 40.0 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | SSA: Day 29 (N'=1,33,30,27,29) | 63.0 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | ILA: Day 29 (N'=0,32,32,29,27) | 65.5 percentage of subjects |
| Dysport 50 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | ILA: Day 29 (N'=0,32,32,29,27) | 40.7 percentage of subjects |
| Dysport 50 U | Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders | SSA: Day 29 (N'=1,33,30,27,29) | 34.5 percentage of subjects |
Secondary
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
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.
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: 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;
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=18,17,13,14) | 11.1 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=18,17,13,14) | 11.1 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 29 (N'=18,17,13,14) | 5.6 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=17,16,13,14) | 11.8 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=18,17,12,14) | 5.6 percentage of subjects |
| Placebo | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=18,17,13,14) | 11.1 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=18,17,13,14) | 52.9 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=17,16,13,14) | 81.3 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=18,17,13,14) | 70.6 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 29 (N'=18,17,13,14) | 82.4 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=18,17,13,14) | 70.6 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=18,17,12,14) | 82.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=18,17,13,14) | 92.3 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 29 (N'=18,17,13,14) | 76.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=17,16,13,14) | 76.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=18,17,13,14) | 53.8 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=18,17,12,14) | 75.0 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=18,17,13,14) | 76.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 85 (N'=18,17,12,14) | 64.3 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 113 (N'=18,17,13,14) | 57.1 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 15 (N'=18,17,13,14) | 78.6 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 57 (N'=17,16,13,14) | 78.6 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 8 (N'=18,17,13,14) | 71.4 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. | ILA: Day 29 (N'=18,17,13,14) | 85.7 percentage of subjects |
Secondary
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Time frame: Days 8, 15, 57, 85 and 113
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 57 (N'=34,35,34,34,34) | 0 percentage of subjects |
| Placebo | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 15 (N'=34,36,35,35,34) | 0 percentage of subjects |
| Placebo | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 8 (N'=34,36,35,35,35) | 0 percentage of subjects |
| Placebo | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 113 (N'=34,36,35,34,35) | 0 percentage of subjects |
| Placebo | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 85 (N'=34,33,34,32,34) | 0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 113 (N'=34,36,35,34,35) | 19.4 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 8 (N'=34,36,35,35,35) | 61.1 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 15 (N'=34,36,35,35,34) | 75.0 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 57 (N'=34,35,34,34,34) | 74.3 percentage of subjects |
| Dysport NG 20 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 85 (N'=34,33,34,32,34) | 42.4 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 113 (N'=34,36,35,34,35) | 34.3 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 15 (N'=34,36,35,35,34) | 82.9 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 57 (N'=34,35,34,34,34) | 67.6 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 85 (N'=34,33,34,32,34) | 44.1 percentage of subjects |
| Dysport NG 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 8 (N'=34,36,35,35,35) | 62.9 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 85 (N'=34,33,34,32,34) | 62.5 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 15 (N'=34,36,35,35,34) | 80.0 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 113 (N'=34,36,35,34,35) | 41.2 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 8 (N'=34,36,35,35,35) | 74.3 percentage of subjects |
| Dysport NG 75 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 57 (N'=34,35,34,34,34) | 79.4 percentage of subjects |
| Dysport 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 113 (N'=34,36,35,34,35) | 25.7 percentage of subjects |
| Dysport 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 8 (N'=34,36,35,35,35) | 51.4 percentage of subjects |
| Dysport 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 57 (N'=34,35,34,34,34) | 64.7 percentage of subjects |
| Dysport 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 15 (N'=34,36,35,35,34) | 67.6 percentage of subjects |
| Dysport 50 U | Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. | Day 85 (N'=34,33,34,32,34) | 38.2 percentage of subjects |
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
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
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: ITT Population; N'= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | ILA: Day 8 (N'=34,36,35,35,35) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 15 (N'=33,36,35,35,34) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 29 (N'=34,36,35,33,35) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 57 (N'=33,35,34,34,34) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 85 (N'=34,33,34,32,34) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 113 (N'=34,36,35,34,35) | 0 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 85 (N'=34,33,34,32,34) | 24.2 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 113 (N'=34,36,35,34,35) | 13.9 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 8 (N'=34,36,35,35,35) | 30.6 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 29 (N'=34,36,35,33,35) | 55.6 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 57 (N'=33,35,34,34,34) | 34.3 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 15 (N'=33,36,35,35,34) | 50.0 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 57 (N'=33,35,34,34,34) | 47.1 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 85 (N'=34,33,34,32,34) | 29.4 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 8 (N'=34,36,35,35,35) | 45.7 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 29 (N'=34,36,35,33,35) | 68.6 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 15 (N'=33,36,35,35,34) | 62.9 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 113 (N'=34,36,35,34,35) | 14.3 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 57 (N'=33,35,34,34,34) | 44.1 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 15 (N'=33,36,35,35,34) | 57.1 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 29 (N'=34,36,35,33,35) | 63.6 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 113 (N'=34,36,35,34,35) | 20.6 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 85 (N'=34,33,34,32,34) | 31.3 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 8 (N'=34,36,35,35,35) | 45.7 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 85 (N'=34,33,34,32,34) | 26.5 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 29 (N'=34,36,35,33,35) | 57.1 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 15 (N'=33,36,35,35,34) | 50.0 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 113 (N'=34,36,35,34,35) | 8.6 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 57 (N'=33,35,34,34,34) | 41.2 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 8 (N'=34,36,35,35,35) | 31.4 percentage of subjects |
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
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.
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: ITT Population; N'= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | SSA: Day 15 (N'=33,36,35,35,34) | 0 percentage of subjects |
| Placebo | 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 | SSA: Day 113 (N'=34,36,35,34,35) | 0 percentage of subjects |
| Placebo | 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 | SSA: Day 29 (N'=34,36,35,33,35) | 0 percentage of subjects |
| Placebo | 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 | SSA: Day 85 (N'=34,35,34,32,34) | 0 percentage of subjects |
| Placebo | 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 | SSA: Day 57 (N'=34,35,34,34,34) | 0 percentage of subjects |
| Placebo | 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 | SSA: Day 8 (N'=34,36,35,35,35) | 0 percentage of subjects |
| Dysport NG 20 U | 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 | SSA: Day 29 (N'=34,36,35,33,35) | 52.8 percentage of subjects |
| Dysport NG 20 U | 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 | SSA: Day 113 (N'=34,36,35,34,35) | 8.3 percentage of subjects |
| Dysport NG 20 U | 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 | SSA: Day 15 (N'=33,36,35,35,34) | 52.8 percentage of subjects |
| Dysport NG 20 U | 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 | SSA: Day 8 (N'=34,36,35,35,35) | 25.0 percentage of subjects |
| Dysport NG 20 U | 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 | SSA: Day 57 (N'=34,35,34,34,34) | 40.0 percentage of subjects |
| Dysport NG 20 U | 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 | SSA: Day 85 (N'=34,35,34,32,34) | 28.6 percentage of subjects |
| Dysport NG 50 U | 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 | SSA: Day 15 (N'=33,36,35,35,34) | 57.1 percentage of subjects |
| Dysport NG 50 U | 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 | SSA: Day 29 (N'=34,36,35,33,35) | 60.0 percentage of subjects |
| Dysport NG 50 U | 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 | SSA: Day 8 (N'=34,36,35,35,35) | 42.9 percentage of subjects |
| Dysport NG 50 U | 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 | SSA: Day 85 (N'=34,35,34,32,34) | 29.4 percentage of subjects |
| Dysport NG 50 U | 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 | SSA: Day 57 (N'=34,35,34,34,34) | 52.9 percentage of subjects |
| Dysport NG 50 U | 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 | SSA: Day 113 (N'=34,36,35,34,35) | 22.9 percentage of subjects |
| Dysport NG 75 U | 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 | SSA: Day 85 (N'=34,35,34,32,34) | 31.3 percentage of subjects |
| Dysport NG 75 U | 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 | SSA: Day 57 (N'=34,35,34,34,34) | 44.1 percentage of subjects |
| Dysport NG 75 U | 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 | SSA: Day 29 (N'=34,36,35,33,35) | 57.6 percentage of subjects |
| Dysport NG 75 U | 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 | SSA: Day 8 (N'=34,36,35,35,35) | 40.0 percentage of subjects |
| Dysport NG 75 U | 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 | SSA: Day 113 (N'=34,36,35,34,35) | 11.8 percentage of subjects |
| Dysport NG 75 U | 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 | SSA: Day 15 (N'=33,36,35,35,34) | 54.3 percentage of subjects |
| Dysport 50 U | 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 | SSA: Day 113 (N'=34,36,35,34,35) | 17.1 percentage of subjects |
| Dysport 50 U | 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 | SSA: Day 8 (N'=34,36,35,35,35) | 34.3 percentage of subjects |
| Dysport 50 U | 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 | SSA: Day 15 (N'=33,36,35,35,34) | 47.1 percentage of subjects |
| Dysport 50 U | 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 | SSA: Day 29 (N'=34,36,35,33,35) | 57.1 percentage of subjects |
| Dysport 50 U | 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 | SSA: Day 57 (N'=34,35,34,34,34) | 47.1 percentage of subjects |
| Dysport 50 U | 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 | SSA: Day 85 (N'=34,35,34,32,34) | 29.4 percentage of subjects |
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
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.
Time frame: Days 8, 15, 29, 57, 85 and 113
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | ILA: Day 8 (N'=18,17,13,14,19) | 5.6 percentage of subjects |
| Placebo | 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 | ILA: Day 15 (N'=18,17,13,14,18) | 5.6 percentage of subjects |
| Placebo | 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 | ILA: Day 29 (N'=18,17,13,14,19) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 57 (N'=17,16,13,14,19) | 5.9 percentage of subjects |
| Placebo | 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 | ILA: Day 85 (N'=18,17,12,14,19) | 0 percentage of subjects |
| Placebo | 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 | ILA: Day 113 (N'=18,17,13,14,19) | 0 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 85 (N'=18,17,12,14,19) | 17.6 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 113 (N'=18,17,13,14,19) | 5.9 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 8 (N'=18,17,13,14,19) | 5.9 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 29 (N'=18,17,13,14,19) | 11.8 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 57 (N'=17,16,13,14,19) | 18.8 percentage of subjects |
| Dysport NG 20 U | 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 | ILA: Day 15 (N'=18,17,13,14,18) | 17.6 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 57 (N'=17,16,13,14,19) | 15.4 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 85 (N'=18,17,12,14,19) | 16.7 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 8 (N'=18,17,13,14,19) | 23.1 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 29 (N'=18,17,13,14,19) | 23.1 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 15 (N'=18,17,13,14,18) | 23.1 percentage of subjects |
| Dysport NG 50 U | 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 | ILA: Day 113 (N'=18,17,13,14,19) | 23.1 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 57 (N'=17,16,13,14,19) | 21.4 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 15 (N'=18,17,13,14,18) | 21.4 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 29 (N'=18,17,13,14,19) | 28.6 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 113 (N'=18,17,13,14,19) | 14.3 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 85 (N'=18,17,12,14,19) | 7.1 percentage of subjects |
| Dysport NG 75 U | 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 | ILA: Day 8 (N'=18,17,13,14,19) | 21.4 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 85 (N'=18,17,12,14,19) | 15.8 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 29 (N'=18,17,13,14,19) | 21.1 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 15 (N'=18,17,13,14,18) | 16.7 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 113 (N'=18,17,13,14,19) | 5.3 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 57 (N'=17,16,13,14,19) | 15.8 percentage of subjects |
| Dysport 50 U | 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 | ILA: Day 8 (N'=18,17,13,14,19) | 10.5 percentage of subjects |
Other Pre-specified
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to Day 113 (±3 days)
Population: Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related and severe TEAE | 0 participants |
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Serious Adverse Event (SAE) | 0 participants |
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to death | 0 participants |
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related TEAE | 5 participants |
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Severe TEAE | 0 participants |
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE | 12 participants |
| Placebo | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to withdrawal | 0 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to withdrawal | 0 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related and severe TEAE | 0 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Serious Adverse Event (SAE) | 1 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Severe TEAE | 1 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE | 15 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to death | 0 participants |
| Dysport NG 20 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related TEAE | 6 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related and severe TEAE | 0 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE | 10 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Severe TEAE | 0 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related TEAE | 4 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to withdrawal | 0 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to death | 0 participants |
| Dysport NG 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Serious Adverse Event (SAE) | 0 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related TEAE | 4 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to withdrawal | 0 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Severe TEAE | 0 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Serious Adverse Event (SAE) | 0 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to death | 0 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE | 11 participants |
| Dysport NG 75 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related and severe TEAE | 0 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related TEAE | 2 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Serious Adverse Event (SAE) | 0 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to death | 0 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE leading to withdrawal | 0 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Severe TEAE | 0 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | TEAE | 10 participants |
| Dysport 50 U | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study | Related and severe TEAE | 0 participants |