NCT04081402

Brief Summary

A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 5, 2019

Last Update Submit

September 5, 2019

Conditions

Crow's Feet Lines

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]

    4 weeks

Study Arms (2)

HU-014 Inj

EXPERIMENTAL
Biological: HU-014

Botox Inj

ACTIVE COMPARATOR
Biological: Botox Inj

Interventions

HU-014BIOLOGICAL

Hutox Inj(Clostridium botulinum type A)

HU-014 Inj
Botox InjBIOLOGICAL

Botox Inj(Clostridium botulinum type A)

Botox Inj

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

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 within 48 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

Study Sites (1)

Huons

Seoul, South Korea

RECRUITING

Central Study Contacts

Jungmin Yu, Researcher

CONTACT

070-7492-5100jungmin-yu@huons.com

Yubeen Choi, Researcher

CONTACT

070-7492-5965ybin9398@huons.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

February 1, 2020

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)