The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines

Phase 1

Completed

• Conditions: Glabellar Lines
• Interventions: Biological: HU-014 Inj; Biological: Botox Inj

• Registration Number: NCT02961673
• Lead Sponsor: Huons Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Primary Completion: 2017-02
• Study Completion: 2017-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HU-014 Inj(Phase 1 and 2)	HU-014 Inj	HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
Botox Inj(Phase 2)	Botox Inj	Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)

Primary Outcome Measures

Name	Time	Method
Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)	Week 4
Change from Baseline of Glabellar Lines improvement rate(Frown)	Week 4

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Huons; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of