NCT03440671

Brief Summary

A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar 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
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2017

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 30, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

January 11, 2018

Last Update Submit

April 10, 2018

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

  • FWS(Facial Wrinkle Severity) Improvement at glabellar line

    Change from Baseline of Glabellar Lines improvement rate(Frown)

    4 Weeks

Study Arms (2)

Hutox Inj

EXPERIMENTAL

Hutox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)

Biological: Hutox Inj

Botox Inj

ACTIVE COMPARATOR

Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)

Biological: Botox Inj

Interventions

Hutox InjBIOLOGICAL

Hutox Inj(Clostridium botulinum type A)

Hutox Inj
Botox InjBIOLOGICAL

Botox Inj(Clostridium botulinum type A)

Botox Inj

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 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

Seongnam-si, Gyeonggi-do, 13486, South Korea

Location

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

January 11, 2018

First Posted

February 22, 2018

Study Start

November 30, 2017

Primary Completion

October 30, 2018

Study Completion

December 30, 2018

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations

KR(1)