- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224015
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
February 24, 2014 updated by: Allergan
This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
684
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
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British Columbia
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Vancouver, British Columbia, Canada
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Antibes, France
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Berlin, Germany
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California
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Newport Beach, California, United States
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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:
- Successfully completed Study 191622-099
Exclusion Criteria:
- Known immunization or hypersensitivity to botulinum toxin of any serotype
- Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Anticipated need for surgery or hospitalization during the study
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: onabotulinumtoxinA 24U
24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
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Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
Other Names:
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Placebo Comparator: placebo (normal saline)
Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
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Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
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Experimental: onabotulinumtoxinA 44U
44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
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44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment.
Patients may receive up to 2 treatments during the study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
Time Frame: Day 30
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The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe.
The percentage of participants with a score of none or mild at Day 30 is reported.
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Day 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
October 18, 2010
First Submitted That Met QC Criteria
October 18, 2010
First Posted (Estimate)
October 19, 2010
Study Record Updates
Last Update Posted (Estimate)
February 25, 2014
Last Update Submitted That Met QC Criteria
February 24, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 191622-104
- 2010-021271-83 (EudraCT Number)
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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