Clinical trial NCT05059587: Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 318
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Week 4
Secondary outcomes:
measure: Investigator-rated improvement rate of glabellar lines at maximum frown
timeFrame: Week 8, 12, 16
measure: Participant-rated improvement rate of glabellar lines at maximum frown
timeFrame: Week 4, 8, 12, 16
measure: Investigator-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Independent photo evaluator-rated improvement rate of glabellar lines at frown
timeFrame: Week 4, 8, 12, 16
measure: Independent photo evaluator-rated improvement rate of glabellar lines at rest
timeFrame: Week 4, 8, 12, 16
measure: Participant-rated satisfaction after treatment
timeFrame: Week 4, 8, 12, 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Hospital
state: Dongjak-gu
Study officials:
References: