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

NCT05321979 | Completed Phase 3

• 1 other identifier: MT14-KR21GBL1202
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle

  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

  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

  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

  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

  at week 4, week 8 and 12 of each cycle

Study Arms (1)

MBA-P01

EXPERIMENTAL

MBA-P01 will be injected into GL:

Drug: MBA-P01

Interventions

MBA-P01 DRUG

MBA-P01 will be injected into the Glabellar line.

MBA-P01

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medytox Korea: lead

Study Sites (1)

Chung-Ang Univ. Hospital

Seoul, Dongjak-gu, 06973, South Korea

Location

Related Publications (1)

• Han HS, Kim WS, Lee YW, Won CH, Lee W, Choi SY, Kim BJ. Long-term safety and efficacy of MBA-P01 for the treatment of glabellar lines: results from a multicenter, repeated-dose, open-label extension study. J Dermatolog Treat. 2024 Dec;35(1):2418919. doi: 10.1080/09546634.2024.2418919. Epub 2024 Oct 27.

  PMID: 39462517 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: February 7, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

KR (1)