Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines

Recruitment & Eligibility

Inclusion Criteria

Men and women aged between 19 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 lines within 6 months
Patients who were injected with botulinum toxin within the past 6 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

Study & Design

Arm && Interventions

Group	Intervention	Description
MBA-P01	MBA-P01	MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1.
BOTOX®	BOTOX	BOTOX® will be injected into the GL: initial double-blind treatment on Day 1.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4.	Week 4	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Secondary Outcome Measures

Name	Time	Method
Investigator-rated improvement rate of glabellar lines at maximum frown	Week 8, 12, 16	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Participant-rated improvement rate of glabellar lines at maximum frown	Week 4, 8, 12, 16	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Investigator-rated improvement rate of glabellar lines at rest	Week 4, 8, 12, 16	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Independent photo evaluator-rated improvement rate of glabellar lines at rest	Week 4, 8, 12, 16	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Participant-rated improvement rate of glabellar lines at rest	Week 4, 8, 12, 16	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Independent photo evaluator-rated improvement rate of glabellar lines at frown	Week 4, 8, 12, 16	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Participant-rated satisfaction after treatment	Week 4, 8, 12, 16	Participant evaluate the level of satisfaction by 7-grade score (1 to 7) where 1= very dissatisfied 7=very satisfied

Recruitment & Eligibility