NCT02450526

Dysport in the Treatment of Glabellar Lines in Chinese Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The first treatment cycle will be double blind and subjects will be randomised to receive Dysport, Botox or placebo. After the first treatment cycle, all subjects will receive a maximum of four treatment cycles with Dysport, occurring at intervals of no less than 84 Days (12 weeks) between each treatment cycle, depending upon individual duration of response to Dysport treatment.

Conditions

• Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A
BIOLOGICAL	Botulinum toxin type A
DRUG	Placebo	50 Units
DRUG	Placebo	20 Units

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-01
• Completion: 2017-09-06
• First posted: 2015-05-21
• Last updated: 2019-08-06
• Results posted: 2019-06-06

Locations

10 sites across 1 country: China