Glabellar Frown Lines
Conditions
Brief summary
This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
Interventions
DRUGMBA-P01
MBA-P01 will be injected into the Glabellar line.
Sponsors
Medytox Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| The result of anti-drug-andibodies (ADA) and neutralizing antibodies | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-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 |
| Investigator-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=severe |
| Time to retreatment | Through study completion, an average of 1 year | — |
| 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=severe |
| 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=severe |
| Participant-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 |
Countries
South Korea
Outcome results
None listed