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

Phase 3 Completed 784 enrolled Croma-Pharma GmbH

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2016-03-02
Primary completion: 2016-11-23
Completion: 2017-11-16

Publications

Cox SE, Kaufman-Janette J, Cohen JL, Gold M, Joseph J, Nestor MS, Rzany B, Taylor S, Zhou J, Cecerle M, Pueraro E, Irvine R, Dayan S. LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials. Dermatol Surg. 2024 Jun 1;50(6):535-541. doi: 10.1097/DSS.0000000000004152. Epub 2024 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	letibotulinumtoxinA	Protein / enzyme biologic	20 iu	Intramuscular

Indications

No indication recorded.