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

Glabellar Frown Lines Clinical Trial

Official title:

A Single-arm Trial, Open-label, Repeated, Long-term, Multi-center, Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of Glabellar Lines With CORETOX®

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04281745
• Other study ID #: MT03-KR19GBL404
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 17, 2019
• Est. completion date: March 16, 2022

Study information

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

Clinical Trial Summary

This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 16, 2022
• Est. primary completion date: June 17, 2020
• 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

Biological:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance 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	Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle	Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild)	At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Primary	Subject-rated improvement rate of glabellar lines at maximum frown		Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Primary	Subject-rated satisfaction at each cycle after treatment		Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Primary	Treatment on-set date		From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Primary	Treatment duration		From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Primary	Number of participants who experienced an adverse event		Baseline to Day 720
Primary	Number of participants with binding and neutralizing antibodies		Screening and Day 720