At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 410 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 410 participants across 1 site.
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
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedJun 2019
Primary CompletionDec 2019
Study CompletionDec 2020
TodayJul 2026
First PostedJun 14, 2019
Enrollment StartApr 29, 2019
Primary CompletionDec 4, 2019
Study CompletionDec 22, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.0 years ago
Interventions
Botulinum Toxin Adrug
Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area
Placebodrug
injection, sodium chloride 0.9 % divided in five 0.1 mL i.m injections into the 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