Efficacy and Safety of Clostridium Botulinum Toxin Type A to Improve Appearance of Moderate to Severe Glabellar Lines

Summary

The purpose of this study was to demonstrate the safety and the efficacy of a single treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used for the improvement in the appearance of moderate to severe glabellar lines (the lines between the eyebrows).

Timeline

Start

2015-01

Primary completion

2015-04

Completion

2015-08

Outcome

Met primary endpoint

registry NUMBER BTX-A-HAC NG Solution (50 U): 88.3 (76.1 to 94.7) Adjusted percentage of responders NCT02353871 ↗

registry BTX-A-HAC NG Solution (50 U) vs Placebo; p <0.0001 NCT02353871 ↗

Publications

• Hilton S, Kestemont P, Sattler G, Volteau M, Thompson C, Andriopoulos B, Prygova I, Berg AK, Ascher B. Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. Dermatol Surg. 2022 Nov 1;48(11):1198-1202. doi: 10.1097/DSS.0000000000003594. Epub 2022 Oct 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	50 iu	Intramuscular

Indications

No indication recorded.