Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
NCT ID: NCT01189747
Last Updated: 2019-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2010-10-01
2011-07-01
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
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
onabotulinumtoxinA
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1
placebo (normal saline)
normal saline injected into bilateral Crow's Feet Line areas on Day 1.
normal saline
Injected into bilateral Crow's Feet Line areas on Day 1
Interventions
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onabotulinumtoxinA
24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1
normal saline
Injected into bilateral Crow's Feet Line areas on Day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)
Exclusion Criteria
* Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
* Oral retinoid therapy within 1 year
* Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
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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Newport Beach, California, United States
Aalst, , Belgium
Vancouver, British Columbia, Canada
Sutton Coldfield, England, United Kingdom
Countries
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References
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Carruthers A, Bruce S, de Coninck A, Connolly S, Cox SE, Davis PG, Campo A, Lei X, Somogyi C, Lee E, McLean H, Beddingfield F. Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2014 Nov;40(11):1181-90. doi: 10.1097/DSS.0000000000000128.
Other Identifiers
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191622-098
Identifier Type: -
Identifier Source: org_study_id
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