Conditions: Canthal Lines
Keywords: Canthal lines
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 335
Healthy volunteers: no

Brief summary:
This double-blind study has two parts for each subject (same population):

Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):

* To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.

Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):

* To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
* To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs.

Detailed description:

Arms:
arm 1: During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo arm 2: During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo

Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Placebo
Intervention descriptions: intervention 1: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. intervention 2: None

Protocol document: