Status:
UNKNOWN
Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX®
Lead Sponsor:
Medy-Tox
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief Summary
This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04281745
Start Date
October 17 2019
End Date
March 16 2022
Last Update
July 28 2020
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea