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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
I.M. (in the muscle) injection on day 1 (single treatment cycle)
I.M. on day 1 (single treatment cycle)
I.M. on day 1 (single treatment cycle)
Private practice
Bordeaux, France
Private practice
Cannes, France
Private practice
Juan-les-Pins, France
Private practice
Paris, France
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
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
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
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
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
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.
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Charité hospital
Berlin, Germany
Private clinic
Dresden, Germany
Private clinic
Munich, Germany
Private clinic
Starnberg, Germany
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 29