MedTrace Logo

The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines

NCT05364580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Glabellar Frown Lines

Interventions

BIOLOGICAL

PROTOXIN

Botulinum toxin Type A

BIOLOGICAL

Botox®

Botulinum toxin Type A

Sponsors & Collaborators

  • Protox Inc.

    lead INDUSTRY

Principal Investigators

  • Kim Beomjoon · Chung-Ang University Hospital, Chung-Ang University College of Medicine

  • Lee Yangwon · Konkuk University Medical Center

  • Kim Moonbeom · Pusan National University Hospital

  • Lee Jonghoon · Nown Eulji Medical Center, Eulji University

  • Shin Minkyung · Kyunghee University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2023-06-20
Completion
2023-10-06

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364580 on ClinicalTrials.gov