問卷

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberMT-TW-PRT-GL02
NCT Number(ClinicalTrials.gov Identfier)NCT03216408

2017-01-01 - 2018-06-30

Phase III

Terminated4

ICD-10Z41.1

Encounter for cosmetic surgery

ICD-9V50.1

Elective surgery for other plastic surgery for unacceptable cosmetic appearance

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

  • Trial Applicant

    MEDYTOX TAIWAN INC.

  • Sponsor

    Medy-Tox

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 陳錫根 Division of Plastic Surgery

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Hsin-Han Chen Division of Plastic Surgery

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chien-Ting Hu Division of Dermatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Patients with moderate to severe glabellar lines

Objectives

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

Test Drug

Neuronox® Inj. (Clostridium Botulinum Toxin A)

Active Ingredient

Clostridium Botulinum Toxin A

Dosage Form

Injection

Dosage

50 Units

Endpoints

4-grade scale by live assessment of glabellar line severity [ Time Frame: 4 weeks after injection ]
Glabellar line improvement rate at maximum frown

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    136 participants

  • Global

    136 participants