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

Medytox

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Drug: MBA-P01; Drug: BOTOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05059587

MT14-KR20GBL309

Details and patient eligibility

About

This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.

Enrollment: 318 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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318 participants in 2 patient groups

MBA-P01

Experimental group

Description:

MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1.

Treatment:

Drug: MBA-P01

BOTOX®

Active Comparator group

Description:

BOTOX® will be injected into the GL: initial double-blind treatment on Day 1.

Treatment:

Drug: BOTOX