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

Medytox

Status and phase: Completed; Phase 3

Conditions: Glabellar Lines

Treatments: Drug: Botox; Drug: Neuronox

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216408

TG1220MED

Details and patient eligibility

About

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

Full 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.

Enrollment: 504 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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504 participants in 2 patient groups

Neuronox

Experimental group

Description:

Botulinum toxin type A for Injection

Treatment:

Drug: Neuronox

Botox

Active Comparator group

Description:

Botulinum toxin type A for Injection

Treatment:

Drug: Botox