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The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines

NCT04996810 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-10

No results posted yet for this study

Summary

This study will be conducted in Phase I/II clinical trials. In Phase I, 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. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.

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

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

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
2020-12-10
Primary Completion
2021-04-02
Completion
2021-05-26

Countries

  • South Korea

Study Locations

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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 NCT04996810 on ClinicalTrials.gov