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

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

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

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Biological: HU-014 Inj; Biological: Botox Inj

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13486
      • Huons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HU-014 Inj(Phase 1 and 2); HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)	Biological: HU-014 Inj; Clostridium botulinum type A
Active Comparator: Botox Inj(Phase 2); Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)	Biological: Botox Inj; Clostridium botulinum type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HU-014_P1/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No