A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides
NCT ID: NCT02261493
Last Updated: 2017-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
787 participants
INTERVENTIONAL
2014-10-27
2016-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OnabotulinumtoxinA Dose A
OnabotulinumtoxinA Dose A injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
OnabotulinumtoxinA Dose B
OnabotulinumtoxinA Dose B injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
Placebo followed by OnabotulinumtoxinA Dose A
Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria, the subject will receive up to 2 treatments with onabotulinumtoxinA Dose A into the protocol-specified areas.
Normal Saline
Placebo (normal saline) injected into the protocol-specified areas on Day 1.
Interventions
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OnabotulinumtoxinA
OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
Normal Saline
Placebo (normal saline) injected into the protocol-specified areas on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to have facial photos taken
Exclusion Criteria
* Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
* Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
* Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
* Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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The Petrus Center for Aesthetic
Little Rock, Arkansas, United States
Westside Aesthetics
Los Angeles, California, United States
Eye Research Foundation
Newport Beach, California, United States
Steve Yoelin, MD Medical Associates, Inc.
Newport Beach, California, United States
Baumann Cosmetic & Research Institute
Miami, Florida, United States
Saint Louis University
St Louis, Missouri, United States
The Center For Dermatology Cosmetic and Laser Surgery
Mount Kisco, New York, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
The Center for Skin Research
Houston, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Aalst Dermatology Clinic
Aalst, , Belgium
UZ Brussel
Jette, , Belgium
Medical Skin Care - Sint-Truiden
Limbourg, , Belgium
Rosenpark Research
Darmstadt, , Germany
Hautzentrum Koeln (Cologne Dermatology)
Köln Nordrhein-Westfalen, , Germany
Hautok und hautok-cosmetics
München, , Germany
Praxisgemeinschaft Theatiner46
München, , Germany
Hautzentrum am Starnberger See GmbH
Starnberg, , Germany
CentroDerm Study Center
Wuppertal, , Germany
Shakespeare House Health Centre, General Practice
Basingstoke, , United Kingdom
Medizen Clinic
Birmingham, , United Kingdom
The Bosham Clinic
Chichester, , United Kingdom
Waverlery Medical Practice
Coatbridge, , United Kingdom
The Gatehouse
Whitegate, , United Kingdom
Countries
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Other Identifiers
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2014-001815-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-143
Identifier Type: -
Identifier Source: org_study_id
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