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OpenTrials
Completed

NCT Number: NCT03216408

Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox 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.

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Key information

Conditions

Glabellar Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuronox

Drug

Other names: Clostridium Botulinum Toxin A 100 U

Botox

Drug

Other names: Clostridium Botulinum Toxin A 50 U

Primary outcomes

  1. 4-grade scale by live assessment of glabellar line severity

    Time frame: 4 weeks after injection

    Glabellar line improvement rate at maximum frown

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 13, 2017
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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