Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines

Phase 3

Completed

• Conditions: Glabellar Lines
• Interventions: Drug: Neuronox; Drug: Botox

• Registration Number: NCT03216408
• Lead Sponsor: Medy-Tox

Brief Summary

This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with moderate to severe glabellar lines.

Detailed Description

Subjects are randomly assigned into the two groups at the ratio of 2:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with moderate to severe glabellar lines.

Study Timeline

• Study Start: 2016-03-30
• Primary Completion: 2016-11-10
• Study Completion: 2017-03-07
• Status Verified: 2017-07
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-13
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

• Subjects aged between 18 and 65
• Subjects with more than grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown

Exclusion Criteria

• Subjects with medical conditions who may be greater risk due to the administration of the investigational drugs
• Subjects with skin disorders at the injection site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuronox	Neuronox	Botulinum toxin type A for Injection
Botox	Botox	Botulinum toxin type A for Injection

Primary Outcome Measures

Name	Time	Method
4-grade scale by live assessment of glabellar line severity	4 weeks after injection	Glabellar line improvement rate at maximum frown