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

Glabellar Frown Lines Clinical Trial

Official title:

A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289169
• Other study ID #: MT01-KR16GBL401
• Status: Completed
• Phase: Phase 4
• Start date: December 30, 2016
• Est. completion date: May 29, 2019

Study information

• Verified date: August 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	St. Paul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment	Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection	4 weeks after each injection
Secondary	Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment	Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection	4 weeks after each injection