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

Huons Co., Ltd.1 site in 1 country57 target enrollmentSeptember 2016

ConditionsGlabellar Lines

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Glabellar Lines
Sponsor: Huons Co., Ltd.
Enrollment: 57
Locations: 1
Primary Endpoint: Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

March 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huons Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)

Time Frame: Week 4

Change from Baseline of Glabellar Lines improvement rate(Frown)

Time Frame: Week 4

Secondary Outcomes

Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)(Week 4, Week 8, Week 12)
change from Baseline of Glabellar Lines improvement rate (Frown)(Week 8, Week 12)
change from Baseline of Glabellar Lines improvement rate (Not frown)(Week4, Week 8, Week 12)
Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment(Week 4, Week 8, Week 12)
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)