Skip to main content
OpenTrials
Completed

NCT Number: NCT05059587

Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines

This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in treatment of glabellar lines.

Completed

Looking for future studies?

Notify Me

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, 156-755, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged between 19 and 65
  • Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
  • Patients who can comply with the study procedures and visit schedule
  • Patients who voluntarily sign the informed consent

Exclusion criteria

  • Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
  • Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
  • Patients who have received other procedures which may affect glabellar lines within 6 months
  • Patients who were injected with botulinum toxin within the past 6 months
  • Patients with allergy or hypersensitivity to the investigational drugs or their components
  • Patients who have bleeding tendency or taking anti-coagulant
  • Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or 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 with skin disorders or infection at the injection site
  • Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
  • Patients who are unable to communicate or follow the instructions
  • 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.

Botox

Drug

Botox will be injected into the Glabellar line.

Other names: OnabotulinumtoxinA

Primary outcomes

  1. Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4.

    Time frame: Week 4

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Secondary outcomes

  1. Investigator-rated improvement rate of glabellar lines at maximum frown

    Time frame: Week 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  2. Participant-rated improvement rate of glabellar lines at maximum frown

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  3. Investigator-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  4. Participant-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  5. Independent photo evaluator-rated improvement rate of glabellar lines at frown

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  6. Independent photo evaluator-rated improvement rate of glabellar lines at rest

    Time frame: Week 4, 8, 12, 16

    The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

  7. Participant-rated satisfaction after treatment

    Time frame: Week 4, 8, 12, 16

    Participant evaluate the level of satisfaction by 7-grade score (1 to 7) where 1= very dissatisfied 7=very satisfied

Sponsors and collaborators

Lead sponsor

Medytox Korea

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 28, 2021
Registry last updated
Jun 3, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.