Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines

Phase 2 Completed 241 enrolled Merz Aesthetics GmbH Merz Pharmaceuticals GmbH · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).

Timeline

Start: 2019-01-23
Primary completion: 2020-09-10
Completion: 2020-10-08

Outcome

Met primary endpoint

registry Stage 1 and 2 Pooled: NT 201 20 U vs NT 201 100 U; p = 0.0035; Hazard Ratio (HR) 0.56 (95% CI 0.38 to 0.83); Wald Chi-square test NCT03806933 ↗

Publications

Background Kerscher M, Fabi S, Fischer T, Gold M, Joseph J, Prager W, Rzany B, Yoelin S, Roll S, Klein G, Maas C. IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines. J Drugs Dermatol. 2021 Oct 1;20(10):1052-1060. doi: 10.36849/JDD.6377.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	20 iu	Intramuscular

Indications

No indication recorded.