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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01308060
Study type Interventional
Source Galderma R&D
Contact
Status Completed
Phase Phase 3
Start date January 2011
Completion date May 2012

See also
  Status Clinical Trial Phase
Completed NCT05148000 - Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines Phase 3