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

NCT05059587 | Completed Phase 3

• 1 other identifier: MT14-KR20GBL309
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Investigator-rated improvement rate of glabellar lines at maximum frown

  Week 8, 12, 16

• Participant-rated improvement rate of glabellar lines at maximum frown

  Week 4, 8, 12, 16

• Investigator-rated improvement rate of glabellar lines at rest

  Week 4, 8, 12, 16

• Participant-rated improvement rate of glabellar lines at rest

  Week 4, 8, 12, 16

• Independent photo evaluator-rated improvement rate of glabellar lines at frown

  Week 4, 8, 12, 16

Study Arms (2)

MBA-P01

EXPERIMENTAL

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

Drug: MBA-P01

BOTOX®

ACTIVE COMPARATOR

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

Drug: BOTOX

Interventions

MBA-P01 DRUG

MBA-P01 will be injected into the Glabellar line.

MBA-P01

BOTOX DRUG

Botox will be injected into the Glabellar line.

Also known as: OnabotulinumtoxinA

BOTOX®

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medytox Korea: lead

Study Sites (1)

Chung-Ang Univ. Hospital

Seoul, Dongjak-gu, 156-755, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: August 30, 2021
• Primary Completion: December 29, 2021
• Study Completion: March 29, 2022
• Last Updated: June 3, 2022

Record last verified: 2021-09

Locations

KR (1)