NCT01308060

A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)

A Multi-center Randomized, Double-blind, Placebo Controlled, Parallel-group Study of CD07743 for the Improvement of Lateral Canthal Lines (Crow's Feet)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Canthal Lines

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A	During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
OTHER	Placebo

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-03-03
• Last updated: 2020-05-01
• Results posted: 2020-05-01