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

Medy-Tox504 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

504

Conditions

Glabellar Lines

Interventions

NeuronoxDRUG

BotoxDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

4-grade scale by live assessment of glabellar line severity

Glabellar line improvement rate at maximum frown

Time frame: 4 weeks after injection

Data from ClinicalTrials.gov

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