A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

Protox Inc.5 sites in 1 country269 target enrollmentMarch 6, 2023

ConditionsGlabellar Frown Lines

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Glabellar Frown Lines
Sponsor: Protox Inc.
Enrollment: 269
Locations: 5
Primary Endpoint: 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
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.

Registry

clinicaltrials.gov

Start Date

March 6, 2023

End Date

October 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Protox Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women aged between 19 to 65 years old
•Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
•Those who understand and comply with clinical trial procedures and visit schedules
•Subjects who voluntarily decides to participate and signs the consent form after hearing the explanation of this clinical trial.
•Exclusion Criteria
•Those with or accompanied by the following diseases at the time of screening
•Subjects with Neuromuscular Junction Disorder that may affect neuromuscular action
•Subjects with previous history of weakness or paralysis in the forehead area
•Subjects with infection, skin disorders, or scars at the glabellar region
•Subjects with wrinkles that physically prevent wrinkles from spreading, such as when wrinkles are not spread out by hand

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: 4 weeks post injection compared to baseline

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 Outcomes

Participant-rated improvement rate of glabellar lines at rest(Week 4, 8, 12, 16)
Independent photo evaluator-rated improvement rate of glabellar lines at frown(Week 4, 8, 12, 16)
Investigator-rated improvement rate of glabellar lines at maximum frown(Week 8, 12, 16)
Investigator-rated improvement rate of glabellar lines at rest(Week 4, 8, 12, 16)
Participant-rated satisfaction after treatment(Week 4, 8, 12, 16)
Participant-rated improvement rate of glabellar lines at maximum frown(Week 4, 8, 12, 16)
Independent photo evaluator-rated improvement rate of glabellar lines at rest(Week 4, 8, 12, 16)