Clinical trial NCT05321979: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 253
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

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.
timeFrame: Through study completion, an average of 1 year
measure: Incidence rate of TEAE, ADR, SAE and AESI of each cycle
timeFrame: Through each cycle, an average of 3 months
measure: The change of laboratory test and vital sign
timeFrame: Through study completion, an average of 1 year
measure: The result of anti-drug-andibodies (ADA) and neutralizing antibodies
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle
timeFrame: at week 4, week 8 and 12 of each cycle
measure: Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle
timeFrame: at week 4, week 8 and 12 of each cycle
measure: Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle
timeFrame: at week 4, week 8 and 12 of each cycle
measure: Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle
timeFrame: at week 4, week 8 and 12 of each cycle
measure: Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle
timeFrame: at week 4, week 8 and 12 of each cycle
measure: Time to retreatment
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Hospital
state: Dongjak-gu
Study officials:
References: