Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea

July 2, 2019 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

667

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of, 135-839
        • Dr. Robbin Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Botulinum toxin Type A injected into crow's feet line areas per clinical practice.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale
Time Frame: Baseline, Up to 3 months
Baseline, Up to 3 months
Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale
Time Frame: Baseline, Up to 3 months
Baseline, Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2014

Primary Completion (Actual)

August 14, 2017

Study Completion (Actual)

August 14, 2017

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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