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

NCT03289169 | Completed Phase 4

• 1 other identifier: MT01-KR16GBL401
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment

  improvement are defined as subjects with glabellar line severity of none (0) or mild (1).

  4 weeks after final injection

Secondary Outcomes (2)

• Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment

  4 weeks after each injection

• Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment

  4 weeks after each injection

Study Arms (1)

MEDITOXIN

EXPERIMENTAL

Meditoxin(Botulinum toxin type A)

Drug: MEDITOXIN®

Interventions

MEDITOXIN® 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.

Also known as: Neuronox®

MEDITOXIN

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

St. Paul Hospital

Seoul, 130-709, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 20, 2017
• Study Start: December 30, 2016
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

KR (1)