At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 784 enrolled
Drug / intervention
Botulinum Toxin A +2 moredrug
Likely dose
Botulinum Toxin A 20 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.
Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo, Followed by an Open Label Extension Study
In Brief
A Phase 3 clinical trial evaluating Botulinum Toxin A and Placebo for Glabellar Frown Lines. Completed, enrolled 784 participants across 18 sites in 3 countries.
Detailed Summary
The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of glabellar lines in comparison with placebo, including efficacy after repeat treatments and long term safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Frown Lines
CountriesGermany, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionNov 2016
Study CompletionNov 2017
TodayJul 2026
First PostedFeb 9, 2016
Enrollment StartMar 2, 2016
Primary CompletionNov 23, 2016
Study CompletionNov 16, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago
Interventions
Botulinum Toxin Adrug
Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area.
Placebodrug
Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area
Botulinum Toxin Adrug
Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles