NCT04443244

Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hugel · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Detailed description

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Conditions

• Benign Masseteric Hypertrophy

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A Injection (Botulax®) 24Units	Experimental: Botulax® 24Units
DRUG	Botulinum Toxin Type A Injection (Botulax®) 48Units	Experimental: Botulax® 48Units
DRUG	Botulinum Toxin Type A Injection (Botulax®) 72Units	Experimental: Botulax® 72Units
DRUG	Botulinum Toxin Type A Injection (Botulax®) 96Units	Experimental: Botulax® 96Units
OTHER	Normal Saline	Placebo Comparator: Normal Saline

Timeline

• Start date: 2020-05-27
• Primary completion: 2020-11-18
• Completion: 2021-07-16
• First posted: 2020-06-23
• Last updated: 2021-11-16

Locations

1 site across 1 country: South Korea