NCT04996810

The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines

A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Protox Inc. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted in Phase I/II clinical trials. In Phase I, 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. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.

Conditions

• Glabellar Frown Lines

Interventions

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

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-04-02
• Completion: 2021-05-26
• First posted: 2021-08-09
• Last updated: 2021-08-10

Locations

2 sites across 1 country: South Korea