Conditions: Glabellar Lines
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 520
Healthy volunteers: no

Brief summary:
The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects.

Detailed description:
The first treatment cycle will be double blind and subjects will be randomised to receive Dysport, Botox or placebo. After the first treatment cycle, all subjects will receive a maximum of four treatment cycles with Dysport, occurring at intervals of no less than 84 Days (12 weeks) between each treatment cycle, depending upon individual duration of response to Dysport treatment.

Arms:
arm 1: Dysport, 50 Units, divided into five injections into the glabellar area. Administered in double blind fashion at cycle 1 followed by up to 4 cycles Dysport, 50 Units administered with an interval period depending on response, no less than 12 weeks between each treatment cycle. arm 2: Botox will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area. arm 3: Dysport placebo will be administered in treatment cycle 1 only. On Day 1, 50 Units, divided into five injections into the glabellar area. arm 4: Botox placebo will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.

Interventions: intervention 1: Botulinum toxin type A intervention 2: Botulinum toxin type A intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: 50 Units intervention 4: 20 Units

Protocol document: