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

Glabellar Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05321979
• Other study ID #: MT14-KR21GBL1202
• Status: Completed
• Phase: Phase 3
• Start date: February 7, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2024
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• MBA-P01
MBA-P01 will be injected into the Glabellar line.

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang Univ. Hospital	Seoul	Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Medytox Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence rate of TEAE, ADR, SAE and AESI of each cycle		Through each cycle, an average of 3 months
Primary	The change of laboratory test and vital sign		Through study completion, an average of 1 year
Primary	The result of anti-drug-andibodies (ADA) and neutralizing antibodies		Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to retreatment		Through study completion, an average of 1 year