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

Medytox

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Drug: MBA-P01

Study type: Interventional

Funder types: Industry

Identifiers

NCT05321979

MT14-KR21GBL1202

Details and patient eligibility

About

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

Enrollment: 253 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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253 participants in 1 patient group

MBA-P01

Experimental group

Description:

MBA-P01 will be injected into GL:

Treatment:

Drug: MBA-P01