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

• Sponsor: Medytox Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05059587
• Collaborator: (none)
• Enrollment: 318
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 45.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glabellar Frown Lines	Drug: MBA-P01; Drug: BOTOX	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 318 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Aug 30, 2021
• Actual Primary Completion Date: Dec 29, 2021
• Actual Study Completion Date: Mar 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBA-P01 MBA-P01 will be injected into the GL: initial double-blind treatment on Day 1.	Drug: MBA-P01; MBA-P01 will be injected into the Glabellar line.
Active Comparator: BOTOX® BOTOX® will be injected into the GL: initial double-blind treatment on Day 1.	Drug: BOTOX; Botox will be injected into the Glabellar line.; Other Names: OnabotulinumtoxinA

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ang Univ. Hospital	Seoul	Dongjak-gu	Korea, Republic of	156-755

Sponsors and Collaborators

• Medytox Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medytox Korea
• ClinicalTrials.gov Identifier: NCT05059587
• Other Study ID Numbers: MT14-KR20GBL309
• First Posted: Sep 28, 2021
• Last Update Posted: Jun 3, 2022
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Botulinum Toxins, Type A

Study Results

No Results Posted as of Jun 3, 2022