NCT02677298

Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study I

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 784 (actual)
• Sponsor: Croma-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This multicenter Phase 3 study is comprised of two parts. The first part of the study is a randomized, double blind, placebo-controlled, phase which aims to demonstrate efficacy and safety of BoNT/A-DP compared with placebo. The second part is an open label extension phase to evaluate efficacy after repeat treatments and long term safety. Subjects can receive a maximum of four treatment cycles over the duration of the study, a single treatment in the first cycle compared with placebo, and up to three subsequent treatments in the open label extension study.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
DRUG	Botulinum Toxin A	Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area.
DRUG	Placebo	Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area
DRUG	Botulinum Toxin A	Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles

Timeline

• Start date: 2016-03-02
• Primary completion: 2016-11-23
• Completion: 2017-11-16
• First posted: 2016-02-09
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

18 sites across 3 countries: United States, Germany, Poland