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

NCT ID: NCT03216408

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-30

Study Completion Date

2017-03-07

Brief Summary

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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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Detailed Description

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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.

Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Neuronox

Botulinum toxin type A for Injection

Group Type EXPERIMENTAL

Neuronox

Intervention Type DRUG

Botox

Botulinum toxin type A for Injection

Group Type ACTIVE_COMPARATOR

Botox

Intervention Type DRUG

Interventions

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Neuronox

Intervention Type DRUG

Botox

Intervention Type DRUG

Other Intervention Names

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Clostridium Botulinum Toxin A 100 U Clostridium Botulinum Toxin A 50 U

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TG1220MED

Identifier Type: -

Identifier Source: org_study_id

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