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Completed

NCT Number: NCT05321979

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

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

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Key information

Conditions

Glabellar Frown Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang Univ. Hospital

Seoul, Dongjak-gu, 06973, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBA-P01

Drug

MBA-P01 will be injected into the Glabellar line.

Primary outcomes

  1. 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

  2. Incidence rate of TEAE, ADR, SAE and AESI of each cycle

    Time frame: Through each cycle, an average of 3 months

  3. The change of laboratory test and vital sign

    Time frame: Through study completion, an average of 1 year

  4. The result of anti-drug-andibodies (ADA) and neutralizing antibodies

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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

  4. 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

    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

  5. 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

    Participant evaluate the level of safisfaction by 7-grade score

  6. Time to retreatment

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Medytox Korea

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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