drugset / Trial / NCT01308060

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

NCT01308060 ↗

Phase 3 Completed 335 enrolled Galderma R&D
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-01
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 60 unknown —

Indications