A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Study Identifier
M21-310
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, German, German (Belgium), French (Belgium), Dutch (Belgium)
Scientific Result Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.
Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.
Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.
Participants will attend regular monthly visits during the study at the study site.
Study Locations
Location
Status
Location
Total Skin and Beauty Derm Ctr /ID# 249905
Birmingham, Alabama, United States, 35205
Status
Not applicable
Location
Westside Aesthetics /ID# 231196
Los Angeles, California, United States, 90025-1708
Status
Not applicable
Location
Skin Care and Laser Physicians of Beverly Hills /ID# 231194
Los Angeles, California, United States, 90069
Status
Not applicable
Location
Moradi MD /ID# 244719
Vista, California, United States, 92083-6030
Status
Not applicable
Location
Skin Research Institute LLC /ID# 231195
Coral Gables, Florida, United States, 33146-1837
Status
Not applicable
Location
Skin and Cancer Associates, LLP /ID# 231189
Miami, Florida, United States, 33137-3254
Status
Not applicable
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