Glabellar Lines Clinical Trial
Official title:
A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 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 I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | March 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 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 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 | Seongnam-si | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Huons Co.,Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1) | Week 4 | ||
| Primary | Change from Baseline of Glabellar Lines improvement rate(Frown) | Week 4 | ||
| Secondary | Assessment of Columbia Suicide Severity Rating Scale(C-SSRS) | Week 4, Week 8, Week 12 | ||
| Secondary | change from Baseline of Glabellar Lines improvement rate (Frown) | Week 8, Week 12 | ||
| Secondary | change from Baseline of Glabellar Lines improvement rate (Not frown) | Week4, Week 8, Week 12 | ||
| Secondary | Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment | Week 4, Week 8, Week 12 | ||
| Secondary | Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product | Week 4, Week 8, Week 12 |
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