NCT03837561

The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
DRUG	Cunox	Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
DRUG	Botox	Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.

Timeline

• Start date: 2018-12-13
• Primary completion: 2019-03-12
• Completion: 2019-06-03
• First posted: 2019-02-12
• Last updated: 2020-07-29

Locations

1 site across 1 country: Russia