Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 06973
      • Chung-Ang Univ. Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients who completed the phase III trial (MT14-KR20GBL309)
• Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily

Exclusion Criteria:

• Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309)
• Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period.
• Patient who 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 who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBA-P01; MBA-P01 will be injected into GL:	Drug: MBA-P01; MBA-P01 will be injected into the Glabellar line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments.	Through study completion, an average of 1 year
Incidence rate of TEAE, ADR, SAE and AESI of each cycle	Through each cycle, an average of 3 months
The change of laboratory test and vital sign	Through study completion, an average of 1 year
The result of anti-drug-andibodies (ADA) and neutralizing antibodies	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle	Proportion of paricipants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by investigator *GL severity: 0=none, 1=mild, 2=moderate, 3=severe	at week 4, week 8 and 12 of each cycle
Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle	Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by investigator *GL severity: 0=none, 1=mild, 2=moderate, 3=severe	at week 4, week 8 and 12 of each cycle
Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle	Proportion of participants achieving at least a 2-grade improvement from reatreatment day and a grade 0 (none) or 1 (mild) in GL severity* as assessed by participant *GL severity: 0=none, 1=mild, 2=moderate, 3=severe	at week 4, week 8 and 12 of each cycle
Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle	Proportion of participants who were grade 2 (moderate) on retreatment day and achieving grade 0 (none) or 1 (mild) at week 4, week 8 and 12 in GL severity* as assessed by participant *GL severity: 0=none, 1=mild, 2=moderate, 3=severe	at week 4, week 8 and 12 of each cycle
Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle	Participant evaluate the level of safisfaction by 7-grade score	at week 4, week 8 and 12 of each cycle
Time to retreatment		Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Medytox Korea

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MT14-KR21GBL1202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No