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

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Moderate to Severe Glabellar Lines

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216408

Enrollment

504

Registered

2017-07-13

Start date

2016-03-30

Completion date

2017-03-07

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glabellar Lines

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.

Interventions

DRUGNeuronox

DRUGBotox

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026