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

A Randomized, Double-blind, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

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

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: MBA-P01; Drug: BOTOX

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 156-755
      • Chung-Ang Univ. Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBA-P01; MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1.	Drug: MBA-P01; MBA-P01 will be injected into the Glabellar line.
Active Comparator: BOTOX®; BOTOX® will be injected into the GL: initial double-blind treatment on Day 1.	Drug: BOTOX; Botox will be injected into the Glabellar line.; Other Names: OnabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.	Week 4

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medytox Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): December 29, 2021
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A
• Other Study ID Numbers: MT14-KR20GBL309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No