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
1 other identifier
interventional
57
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedApril 12, 2018
April 1, 2018
5 months
September 26, 2016
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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
Study Arms (2)
HU-014 Inj(Phase 1 and 2)
EXPERIMENTALHU-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)
ACTIVE COMPARATORBotox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
Interventions
Eligibility Criteria
You may qualify if:
- Facial Wrinkle Scale (FWS) score \> 2 when Subject knits brow extremely
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huons Co., Ltd.lead
Study Sites (1)
Huons
Seongnam-si, Gyeonggi-do, 13486, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2016
First Posted
November 11, 2016
Study Start
September 1, 2016
Primary Completion
February 1, 2017
Study Completion
March 1, 2017
Last Updated
April 12, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share