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

Phase 3CompletedNCT05321979

Medytox Korea253 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

253

Conditions

Glabellar Frown Lines

Interventions

MBA-P01DRUG

MBA-P01 will be injected into the Glabellar line.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Chung-Ang Univ. Hospital

Seoul, Dongjak-gu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, an average of 1 year

Incidence rate of TEAE, ADR, SAE and AESI of each cycle

Time frame: Through each cycle, an average of 3 months

The change of laboratory test and vital sign

Time frame: Through study completion, an average of 1 year

The result of anti-drug-andibodies (ADA) and neutralizing antibodies

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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