The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

Summary

This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.

Timeline

Start

2023-03-06

Primary completion

2023-06-20

Completion

2023-10-06

Publications

• Son HS, Shin MK, Lee JH, Kim MB, Yoo KH, Choi SY, Han HS, Seok J, Kim BJ, Lee YW. Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study. Ann Dermatol. 2026 Feb;38(1):33-41. doi: 10.5021/ad.25.124.

Drugs

Indications

No indication recorded.