At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 520 enrolled
Drug / intervention
Botulinum toxin type A +3 morebiological
Likely dose
Placebo 50 Unitsfrom 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.
A Phase III, Randomised, Double Blind and Open Label Phase, Multicentre, Active and Placebo Controlled Study to Investigate the Efficacy and Safety of Dysport Including a Comparison to Botox in the Treatment of Moderate to Severe Glabellar Lines, and to Assess the Long Term Efficacy and Safety of Dysport Following Repeated Treatments in This Indication
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and Placebo for Glabellar Lines. Completed, enrolled 520 participants across 10 sites.
Detailed Summary
The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Lines
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMay 2015
Primary CompletionJul 2016
Study CompletionSep 2017
TodayJul 2026
First PostedMay 21, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 1, 2016
Study CompletionSep 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.1 years ago
Interventions
Botulinum toxin type Abiological
Botulinum toxin type Abiological
Placebodrug
50 Units
Placebodrug
20 Units