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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2023-05-30

Brief Summary

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

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Detailed Description

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Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBA-P01

MBA-P01 will be injected into GL:

Group Type EXPERIMENTAL

MBA-P01

Intervention Type DRUG

MBA-P01 will be injected into the Glabellar line.

Interventions

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MBA-P01

MBA-P01 will be injected into the Glabellar line.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No