Upper Facial Lines
Conditions
Keywords
Glabellar Lines, Lateral Canthal Lines, Forehead Lines, BOTOX, Botulinum Toxin Type A, OnabotulinumtoxinA, Upper Facial Lines, Crows Feet Lines, Wrinkles, Facial Wrinkles, Facial Rhytides
Brief summary
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.
Interventions
DRUGBOTOX
Intramuscular Injections
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe Glabellar Lines, Lateral Canthal Lines, and Forehead Lines. * Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.
Exclusion criteria
* Presence or history of any medical condition that may place the participant at increased risk to BOTOX Cosmetic or interfere with the study evaluation. * Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed. * History of known immunization or hypersensitivity to any botulinum toxin serotype.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function | Day 30 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BOTOX Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | BOTOX |
|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 12.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 19 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
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
Population: Modified Intent-to-Treat Population~N is Number of subjects with observed measurements at the visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BOTOX | 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) | 86 Participants |
Secondary
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
Population: Modified Intent-to-Treat Population~N is Number of participants with observed measurements at both baseline and the given visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOTOX | Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function | 20.1 units on a scale | Standard Deviation 17.96 |