Crow's Feet Lines Clinical Trial
Official title:
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
| Status | Recruiting |
| Enrollment | 290 |
| Est. completion date | February 2020 |
| Est. primary completion date | November 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator 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 within 48 Weeks - Subject who has skin disorder including infection and scar on injection site - 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 | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Huons Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4] | 4 weeks |
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