BOTOX® in the Treatment of Crow's Feet Lines in China

NCT ID: NCT02195687

Last Updated: 2016-03-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lateral Canthal Lines Crow's Feet Lines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

botulinum toxin type A

24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.

placebo

Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

botulinum toxin Type A

botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.

Intervention Type BIOLOGICAL

Normal Saline

Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BOTOX®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Moderate to severe Crow's Feet Lines.

Exclusion Criteria

* Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
* Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
* Any medium-depth or deep facial peels within 5 years
* Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Wu Y, Li C, Garcia J, Baradaran S. Patient-reported Outcomes in Chinese Subjects Treated with OnabotulinumtoxinA for Crow's Feet Lines. J Clin Aesthet Dermatol. 2021 Oct;14(10):27-31.

Reference Type DERIVED
PMID: 34976286 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

191622-113

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Skin Quality Improvement
NCT03097835 COMPLETED PHASE2