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CompletedNCT05059587Updated Jun 3, 2022

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

A Phase 3 interventional study of MBA-P01 and BOTOX in Glabellar Frown Lines, sponsored by Medytox Korea. Completed at 1 site in South Korea. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-03.

Sponsored by Medytox Korea (part of Medy-Tox) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Glabellar Frown Lines
03

In context

Lead sponsor

Medytox Korea is the lead sponsor of 3 studies on the registry; none are open to participants now.

Browse Medytox Korea studies →All Medy-Tox studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    MBA-P01

    MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1.

    Drug: MBA-P01

  • Active comparator
    BOTOX®

    BOTOX® will be injected into the GL: initial double-blind treatment on Day 1.

    Drug: BOTOX

Interventions

  • DrugMBA-P01

    MBA-P01 will be injected into the Glabellar line.

  • DrugBOTOX

    Botox will be injected into the Glabellar line.

    Also known as: OnabotulinumtoxinA

06

What researchers measure

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.

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

    Time frame: Week 4

Secondary outcomes

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

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

    Time frame: Week 8, 12, 16

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

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

    Time frame: Week 4, 8, 12, 16

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

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

    Time frame: Week 4, 8, 12, 16

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

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

    Time frame: Week 4, 8, 12, 16

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

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

    Time frame: Week 4, 8, 12, 16

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

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

    Time frame: Week 4, 8, 12, 16

  7. Participant-rated satisfaction after treatment

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

    Time frame: Week 4, 8, 12, 16

07

Study locations

1 site
  • Chung-Ang Univ. Hospital
    Seoul, Dongjak-gu 156-755, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05059587
Lead sponsor
Medytox Korea
Responsible party
Sponsor
First posted
Sep 28, 2021
Start date
Aug 30, 2021
Primary completion
Dec 29, 2021
Completion
Mar 29, 2022
Last update
Jun 3, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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