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

Glabellar Frown Lines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05059587
• Other study ID #: MT14-KR20GBL309
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: September 2021
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 29, 2022
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• MBA-P01
MBA-P01 will be injected into the Glabellar line.
• BOTOX
Botox will be injected into the Glabellar line.

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang Univ. Hospital	Seoul	Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Medytox Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4
Secondary	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.	Week 8, 12, 16
Secondary	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.	Week 4, 8, 12, 16
Secondary	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.	Week 4, 8, 12, 16
Secondary	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.	Week 4, 8, 12, 16
Secondary	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.	Week 4, 8, 12, 16
Secondary	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.	Week 4, 8, 12, 16
Secondary	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	Week 4, 8, 12, 16