## Protocol Section
### Identification Module
**NCT ID:** NCT05321979

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

**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

#### Organization Study ID Info
**ID:** MT14-KR21GBL1202
#### Organization
**Class:** INDUSTRY
**Full Name:** Medy-Tox
### Status Module
#### Completion Date
**Date:** 2023-05-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-05-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-02-07

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2022-04-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-03-23
**Study First Submit QC Date:** 2022-04-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Medytox Korea

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Glabellar Frown Lines

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 253

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** MBA-P01 will be injected into GL:

**Intervention Names:**

- Drug: MBA-P01

**Label:** MBA-P01

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MBA-P01

**Description:** MBA-P01 will be injected into the Glabellar line.

**Name:** MBA-P01

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

**Measure:** Incidence rate of TEAE, ADR, SAE and AESI of each cycle

**Time Frame:** Through each cycle, an average of 3 months

**Measure:** The change of laboratory test and vital sign

**Time Frame:** Through study completion, an average of 1 year

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

**Time Frame:** Through study completion, an average of 1 year

#### Secondary Outcomes

**Description:** 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

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

**Time Frame:** at week 4, week 8 and 12 of each cycle

**Description:** 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

**Measure:** Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle

**Time Frame:** at week 4, week 8 and 12 of each cycle

**Description:** 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

**Measure:** Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle

**Time Frame:** at week 4, week 8 and 12 of each cycle

**Description:** 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

**Measure:** Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle

**Time Frame:** at week 4, week 8 and 12 of each cycle

**Description:** Participant evaluate the level of safisfaction by 7-grade score

**Measure:** Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle

**Time Frame:** at week 4, week 8 and 12 of each cycle

**Measure:** Time to retreatment

**Time Frame:** Through study completion, an average of 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Chung-Ang Univ. Hospital

**State:** Dongjak-gu

**Zip:** 06973

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
