NCT03408236

Brief Summary

To determine the efficacy and safety of Botulax® in treatment of crow's feet line

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

January 8, 2018

Last Update Submit

April 14, 2022

Conditions

Crow's Feet Lines

Outcome Measures

Primary Outcomes (1)

  • Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators

    The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported as assessed by investigators

    4weeks

Study Arms (2)

Botulax

EXPERIMENTAL

Single dose

Drug: Botulinum toxin type A

Botox

ACTIVE COMPARATOR

Single dose

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type ADRUG

Experimental

Also known as: Botulax
Botulax

Eligibility Criteria

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

You may qualify if:

  • Male or female of at least 19 to 65 years old
  • Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator

You may not qualify if:

  • Subject with hypersensitivity to the investigational products or their components
  • Female subject who are pregnant or lactating
  • Subject who are unable to communicate or follow the instructions
  • Subject who are not eligible for this study based on the judgment of an investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugel

Seoul, South Korea

Location

Related Publications (1)

  • Yoo KH, Park SJ, Han HS, Won CH, Lee YW, Kim BJ. Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1587-1594. doi: 10.1111/jdv.17217. Epub 2021 Apr 12.

    PMID: 33721365DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

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

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 23, 2018

Study Start

January 17, 2018

Primary Completion

December 13, 2018

Study Completion

June 7, 2019

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

KR(1)