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

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

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: Neuronox; Drug: Botox

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 Type: Interventional
• Enrollment (Actual): 504
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuronox; Botulinum toxin type A for Injection	Drug: Neuronox; Other Names: Clostridium Botulinum Toxin A 100 U
Active Comparator: Botox; Botulinum toxin type A for Injection	Drug: Botox; Other Names: Clostridium Botulinum Toxin A 50 U

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2016
• Primary Completion (Actual): November 10, 2016
• Study Completion (Actual): March 7, 2017

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: TG1220MED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No