Clinical trial NCT01333397: Safety and Efficacy Study of Dysport RU and Glabellar Lines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 176
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
timeFrame: Day 29
Secondary outcomes:
measure: Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
timeFrame: Day 29
measure: Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
timeFrame: Days 8, 15, 57, 85 and 113
measure: Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
timeFrame: Days 8, 15, 57, 85 and 113
measure: Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
timeFrame: Days 8, 15, 57, 85 and 113
measure: Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
timeFrame: Day 113
measure: 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
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: 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
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: 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
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
timeFrame: Days 8, 15, 29, 57, 85 and 113
measure: 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)
timeFrame: Day 29
Other outcomes:
measure: Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
timeFrame: Up to Day 113 (±3 days)
Locations:
city: Bordeaux
country: France
facility: Private practice
city: Cannes
country: France
facility: Private practice
city: Juan Les Pins
country: France
facility: Private practice
city: Paris
country: France
facility: Private practice
city: Berlin
country: Germany
facility: Charité hospital
city: Dresden
country: Germany
facility: Private clinic
city: Munich
country: Germany
facility: Private clinic
city: Starnberg
country: Germany
facility: Private clinic
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References: