Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX®

NCT ID: NCT04281745

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2022-03-16

Brief Summary

This study evaluates the long-term safety and efficacy of CORETOX 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

Coretox®

Botulinum toxin type A to be intramuscularly injected at 4 sites of corrugator muscle and at 1 site of procerus muscle with 0.1 mL (4U) at each site, for a total of 0.5 mL (20U). The administration of the investigational product was performed once at the start of each cycle

Group Type: EXPERIMENTAL

CORETOX Inj

Intervention Type: BIOLOGICAL

Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline.

Interventions

CORETOX Inj

Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline.

Intervention Type: BIOLOGICAL

Other Intervention Names

Botulinum toxin type A

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

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MT03-KR19GBL404

Identifier Type: -

Identifier Source: org_study_id