Phase 3 Study of Eveotox Compared With Botox and Placebo for Treating Moderate to Severe Glabellar Lines Includes Single and Repeated Injections to Evaluate Effectiveness and Safety

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and immune response of single and repeated injections of Eveotox, a recombinant botulinum toxin type A, for treating moderate to severe glabellar lines frown lines. This Phase 3 study includes two parts Part 1 is a randomized, double-blind, controlled trial comparing Eveotox with Botox and placebo Part 2 is an open-label study assessing repeated Eveotox injections. Participants in Part 1 receive one injection cycle of either Eveotox 20 Units, Botox 20 Units, or placebo in a double-blind manner. Following this, all participants may receive up to three open-label cycles of Eveotox injections 20 Units each. The injections are administered in five divided doses into the glabellar area. Throughout the study, participants will attend scheduled visits to monitor treatment effects and safety. Researchers will assess the severity of glabellar lines using both investigator and patient scales within 4 weeks after treatment, with additional safety and efficacy evaluations continuing up to 52 weeks. The study aims to fully assess the treatments impact and immune response over time.

Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines