A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides
NCT ID: NCT02261467
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2014-10-21
2016-04-26
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
OnabotulinumtoxinA 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 in Period 2
Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA 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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Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Advanced Research Associates
Glendale, Arizona, United States
Clinical Science Institute
Santa Monica, California, United States
About Skin Dermatology and DermSurgery, PC
Greenwood Village, Colorado, United States
Steven Fagien, MD, PA
Boca Raton, Florida, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, United States
Henry Ford Medical Center
West Bloomfield, Michigan, United States
NW Dermatology and Research Center
Portland, Oregon, United States
Carruthers Dermatology Centre
Vancouver, British Columbia, Canada
Dr. Shannon Humphrey, Inc.
Vancouver, British Columbia, Canada
Jean Carruthers Cosmetic Dermatology
Vancouver, British Columbia, Canada
Sweat Clinics of Canada
Toronto, Ontario, Canada
Arthur Swift Research, Inc.
Westmount, Quebec, Canada
Aesthetic Surgery Ireland
Dublin, , Ireland
Beacon Face and Dermatology Clinic
Dublin, , Ireland
Countries
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References
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De Boulle K, Werschler WP, Gold MH, Bruce S, Sattler G, Ogilvie P, Street J, Larsen KE, Yushmanova I, Lei X, Lee E, Vitarella D, Mao C. Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines. Dermatol Surg. 2018 Nov;44(11):1437-1448. doi: 10.1097/DSS.0000000000001612.
Other Identifiers
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2014-001860-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-142
Identifier Type: -
Identifier Source: org_study_id
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