A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
Study Identifier
M21-309
CT.gov Identifier
EudraCT Identifier
Not available
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
Scientific Result Summary
Available Language(s): English
Plain Language 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 in the United States and Canada.
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
Advanced Research Associates - Glendale /ID# 229256
Glendale, Arizona, United States, 85308
Status
Not applicable
Location
Clear Dermatology & Aesthetics Center /ID# 229252
Scottsdale, Arizona, United States, 85255-4134
Status
Not applicable
Location
Clinical Testing of Beverly Hills /ID# 229946
Encino, California, United States, 91436-2124
Status
Not applicable
Location
Dermatology Research Associates /ID# 229949
Los Angeles, California, United States, 90045
Status
Not applicable
Location
Steve Yoelin MD Medical Associate Inc /ID# 229420
Newport Beach, California, United States, 92663
Status
Not applicable
Location
Cosmetic Laser Dermatology /ID# 229245
San Diego, California, United States, 92121-2119
Status
Not applicable
Showing {first} - {last} of {total} Results