Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines

NCT ID: NCT03289169

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-30
• Study Completion Date: 2019-05-29

Brief Summary

This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe glabellar lines.

Conditions

Glabellar Frown Lines

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEDITOXIN

Meditoxin(Botulinum toxin type A)

Group Type: EXPERIMENTAL

MEDITOXIN®

Intervention Type: DRUG

20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.

Interventions

MEDITOXIN®

20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.

Intervention Type: DRUG

Other Intervention Names

Neuronox®

Eligibility Criteria

Inclusion Criteria

• Men and women aged between 20 and 65
• Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
• Patients who can comply with the study procedures and visit schedule
• Patients who voluntarily sign the informed consent

Exclusion Criteria

• Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
• Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
• Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
• Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
• Patients who were injected with botulinum toxin within the past 3 months
• Patients with allergy or hypersensitivity to the investigational drugs or their components
• Patients who have bleeding tendency or taking anti-coagulant
• Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
• Patients with skin disorders or infection at the injection site
• Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
• Patients who are unable to communicate or follow the instructions
• Patients who are not eligible for this study based on the judgment of an investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Paul Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MT01-KR16GBL401

Identifier Type: -

Identifier Source: org_study_id