NCT02248844

Brief Summary

This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous glabellar lines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

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

September 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

September 26, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2017

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.9 years

First QC Date

September 23, 2014

Last Update Submit

July 2, 2019

Conditions

Lateral Canthal LinesCrow's Feet Lines

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events

    Up to 3 months

Secondary Outcomes (2)

  • Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale

    Baseline, Up to 3 months

  • Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale

    Baseline, Up to 3 months

Study Arms (1)

Botulinum Toxin Type A

Subjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice.

Biological: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type ABIOLOGICAL

Botulinum toxin Type A injected into crow's feet line areas per clinical practice.

Also known as: BOTOX®, onabotulinumtoxinA
Botulinum Toxin Type A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with Lateral Canthal Lines (Crow's Feet Lines)

You may qualify if:

  • Subject and Investigator decision to treat crow's feet lines with Botox®

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Robbin Clinic

Gangnam-gu, Seoul, 135-839, South Korea

Location

Related Links

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 25, 2014

Study Start

September 26, 2014

Primary Completion

August 14, 2017

Study Completion

August 14, 2017

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

KR(1)