Safety and Efficacy Study of Dysport RU and Glabellar Lines

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: Botulinum toxin type A
* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysport RU 20 U<br> | Biological: Botulinum toxin type A<br>* I.M. (in the muscle) injection on day 1 (single treatment cycle)<br>* Other names: AbobotulinumtoxinA (DysportRU®);|
| Experimental: Dysport RU 50 U<br> | Biological: Botulinum toxin type A<br>* I.M. (in the muscle) injection on day 1 (single treatment cycle)<br>* Other names: AbobotulinumtoxinA (DysportRU®);|
| Experimental: Dysport RU 75 U<br> | Biological: Botulinum toxin type A<br>* I.M. (in the muscle) injection on day 1 (single treatment cycle)<br>* Other names: AbobotulinumtoxinA (DysportRU®);|
| Active Comparator: Dysport (Azzalure) 50 U<br> | Biological: Botulinum toxin type A<br>* I.M. on day 1 (single treatment cycle)<br>* Other names: AbobotulinumtoxinA (Azzalure®);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* I.M. on day 1 (single treatment cycle)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 29 | 
| 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 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. | Days 8, 15, 29, 57, 85 and 113 | 
| 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. | Day 113 | 
| 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 | Days 8, 15, 29, 57, 85 and 113 | 
| 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. | Days 8, 15, 29, 57, 85 and 113 | 
| 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. | Days 8, 15, 29, 57, 85 and 113 | 
| 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 |