Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01308060
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.
Study:
NCT01308060
Study Brief:
Protocol Section:
NCT01308060