Status:
UNKNOWN
The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines
Eligibility Criteria
Inclusion
- Facial Wrinkle Scale (FWS) score \> 2 when Subject knits brow extremely
Exclusion
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2018
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03440671
Start Date
November 30 2017
End Date
December 30 2018
Last Update
April 12 2018
Active Locations (1)
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1
Huons
Seongnam-si, Gyeonggi-do, South Korea, 13486