Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Intramuscular Injections
Skin Wellness Dermatology - Homewood /ID# 248469
Birmingham, Alabama, United States
The Research Center at The Maas Clinic /ID# 256633
San Francisco, California, United States
Pacific Clinical Innovations /ID# 248467
Vista, California, United States
Kavali Plastic Surgery and Skin Renewal Center /ID# 248472
Atlanta, Georgia, United States
Tennessee Clinical Research Center /ID# 259161
Nashville, Tennessee, United States
Integrated Aesthetics - Spring /ID# 257738
Spring, Texas, United States
SkinDC /ID# 248470
Arlington, Virginia, United States
Skin Matters Medical Aesthetic Centre /ID# 249539
Vancouver, British Columbia, Canada
Project Skin MD - Ottawa /ID# 249718
Ottawa, Ontario, Canada
Bertucci MedSpa Inc. /ID# 249757
Woodbridge, Ontario, Canada
Percentage of Participants With Responder Status of 'Mostly Satisfied' or 'Very Satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction With the Natural Look)
The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with upper facial lines using the FLSQ 5-point scale where: -2=Very dissatisfied and 2=Very satisfied.
Time frame: Day 30
Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function
The FACE-Q Psychological Function is a 10-item scale that measures psychological function. The responses score ranges from 0 to 100. Higher scores reflect a better outcome.
Time frame: Day 30
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