A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Huons Co., Ltd.1 site in 1 country260 target enrollmentNovember 30, 2017

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Glabellar Frown Lines
Sponsor: Huons Co., Ltd.
Enrollment: 260
Locations: 1
Primary Endpoint: FWS(Facial Wrinkle Severity) Improvement at glabellar line
Last Updated: 8 years ago

A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines

Registry

clinicaltrials.gov

Start Date

November 30, 2017

End Date

December 30, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
•From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
•Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc
•Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
•Any condition that, in the view of the investigator, would interfere with study participation