Glabellar Frown Lines Clinical Trial
Official title:
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
| Verified date | April 2018 |
| Source | Huons Co.,Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines
| Status | Active, not recruiting |
| Enrollment | 260 |
| Est. completion date | December 30, 2018 |
| Est. primary completion date | October 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Huons | Seongnam-si | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Huons Co.,Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FWS(Facial Wrinkle Severity) Improvement at glabellar line | Change from Baseline of Glabellar Lines improvement rate(Frown) | 4 Weeks |
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