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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059587
Other study ID # MT14-KR20GBL309
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
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Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
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Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
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Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
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Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3