Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines
NCT ID: NCT01391299
Last Updated: 2019-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
175 participants
INTERVENTIONAL
2011-06-01
2012-02-28
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
TRIPLE
Study Groups
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botulinum toxin Type A (40 Units)
Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
botulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
botulinum toxin Type A (30 Units)
Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
botulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
placebo (Normal saline)
Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.
Normal Saline
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.
Interventions
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botulinum toxin Type A
Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
Normal Saline
Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Oral retinoid therapy within one year
19 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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Toronto, Ontario, Canada
Countries
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References
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Solish N, Rivers JK, Humphrey S, Muhn C, Somogyi C, Lei X, Bhogal M, Caulkins C. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial. Dermatol Surg. 2016 Mar;42(3):410-9. doi: 10.1097/DSS.0000000000000626.
Other Identifiers
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GMA-BTXC-10-002
Identifier Type: -
Identifier Source: org_study_id
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