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

February 17, 2016 updated by: Allergan
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Phase 3

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: botulinum toxin type A
24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
Biological: botulinum toxin Type A
botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.
Other Names:
  • BOTOX®
Placebo Comparator: placebo
Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
Drug: Normal Saline
Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
Time Frame: Day 30
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A
Time Frame: Day 30
The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.
Day 30
Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A
Time Frame: Day 30
The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.
Day 30
Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)
Time Frame: Day 30
Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.
Day 30
Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire
Time Frame: Baseline, Day 30
Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.
Baseline, Day 30
Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)
Time Frame: Day 30
The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.
Day 30

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.

General Publications

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

September 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-113

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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