Lateral Canthal LinesNCT02248844
Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea
An observational study of Lateral Canthal Lines and Crow's Feet Lines, run by Allergan at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lateral Canthal Lines, Crow's Feet Lines
- What is being tested?
- Botulinum Toxin Type A
- How many people
- 667 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2014to 14 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Lateral Canthal Lines (Crow's Feet Lines)
Who may be able to join
- Subject and Investigator decision to treat crow's feet lines with Botox®
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lateral Canthal Lines, Crow's Feet Lines
- Being tested
- Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ABiological
Also called BOTOX®, onabotulinumtoxinA
Botulinum toxin Type A injected into crow's feet line areas per clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Subjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice. Receives: Biological: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Up to 3 months
Secondary outcomes (2)
Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale
Measured: Baseline, Up to 3 months
Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale
Measured: Baseline, Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start26 Sep 2014
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248844
- Sponsor's protocol ID
- 191622-147
- Status last verified
- Jul 2019
- First submitted
- 23 Sep 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea
- ClinicalTrials.gov ID
- NCT02248844
- Acronym / sponsor ID
- 191622-147
- Conditions
- Lateral Canthal Lines, Crow's Feet Lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2014 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | – | Biological: Botulinum Toxin Type ASubjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Lateral Canthal Lines (Crow's Feet Lines)
Key inclusion criteria (1 listed)
- Subject and Investigator decision to treat crow's feet lines with Botox®
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: BOTOX®, onabotulinumtoxinABotulinum toxin Type A injected into crow's feet line areas per clinical practice. | Biological | Botulinum Toxin Type A |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to 3 months
2 secondary outcomes
Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Canthal Lines and Crow's Feet Lines, run by Allergan at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.