Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
- Registration Number
- NCT05321979
- Lead Sponsor
- Medytox Korea
- Brief Summary
This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MBA-P01 MBA-P01 MBA-P01 will be injected into GL:
- Primary Outcome Measures
Name Time Method The result of anti-drug-andibodies (ADA) and neutralizing antibodies Through study completion, an average of 1 year 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. Through study completion, an average of 1 year Incidence rate of TEAE, ADR, SAE and AESI of each cycle Through each cycle, an average of 3 months The change of laboratory test and vital sign Through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle 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=severeInvestigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle 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=severeParticipant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle at week 4, week 8 and 12 of each cycle Participant evaluate the level of safisfaction by 7-grade score
Time to retreatment Through study completion, an average of 1 year Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle 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=severeParticipant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle 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 participant
\*GL severity: 0=none, 1=mild, 2=moderate, 3=severe
Trial Locations
- Locations (1)
Chung-Ang Univ. Hospital
🇰🇷Seoul, Dongjak-gu, Korea, Republic of