NCT05380154

Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.

Phase 3 Clinical Study of Efficacy and Safety Assessment; Multi-center, Randomized, Blind, and Parallel Control; and Positive Control of Botulax® Injection and BOTOX® for Improvement of Moderate to Severe Glabellar Wrinkles

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Hugel · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 3 clinical trial of multi-center, random, blinded\*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.

Detailed description

The case test of 500 qualified test subjects was conducted in 13 institutions nationwide in China. Those who meet all selection criteria and do not meet any of the exclusion criteria are selected as suitable test subjects. The selected test subjects are blinded and divided into the Botulax test group or the BOTOX test group.

Conditions

• Glabellar Lines

Interventions

Type	Name	Description
DRUG	Botulinum Toxin A type for injection (Botulax®)	Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects
DRUG	Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)	Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.

Timeline

• Start date: 2017-05-09
• Primary completion: 2018-01-22
• Completion: 2018-07-06
• First posted: 2022-05-18
• Last updated: 2022-05-24

Locations

1 site across 1 country: South Korea