NCT05364580

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

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Protox Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
BIOLOGICAL	PROTOXIN	Botulinum toxin Type A
BIOLOGICAL	Botox®	Botulinum toxin Type A

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-06-20
• Completion: 2023-10-06
• First posted: 2022-05-06
• Last updated: 2023-11-18

Locations

5 sites across 1 country: South Korea