CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 335 enrolled
Drug / intervention
Botulinum Toxin Type A +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01308060
NCT01308060Phase 3Completed

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

Galderma R&D·interventional·Posted Mar 3, 2011·Updated May 1, 2020

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxin Type A and Placebo for Canthal Lines. Completed, enrolled 335 participants.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCanthal Lines
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2011
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.3 years ago

Interventions

Botulinum Toxin Type Adrug

During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.

Placeboother