Platysma Prominence
Conditions
Keywords
Platysma Prominence, BOTOX, OnabotulinumtoxinA
Brief summary
This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study. Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.
Interventions
DRUGOnabotulinumtoxinA
Intramuscular Injection
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
\- Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period \[randomization/treatment with 4-month follow-up visit\] and Study Exit visit)
Exclusion criteria
* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function * Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention) * Anticipated need for surgery or overnight hospitalization during the study * Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study * Known immunization or hypersensitivity to any botulinum toxin serotype * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months * Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 292 participants were enrolled at 28 sites in the United States and Canada. All participants received at least 1 dose of open-label BOTOX and were included in the intent-to-treat (ITT) and safety populations.
Pre-assignment details
Safety analyses were carried out for the Safety Analysis Set (Safety Population), which consisted of all participants who received study drug in both the lead-in study and in this study (N=292).
Participants by arm
| Arm | Count |
|---|---|
| BOTOX BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle for up to 3 cycles during study M21-323. | 292 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | Other, not specified | 3 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | BOTOX |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 278 Participants |
| Age, Continuous | 49.6 Years STANDARD_DEVIATION 9.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 265 Participants |
| Sex: Female, Male Female | 273 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 292 |
| other Total, other adverse events | 42 / 292 |
| serious Total, serious adverse events | 2 / 292 |
Outcome results
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
Time frame: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (Lead-in) | Number of Participants With Adverse Events | 33 Participants |
| BOTOX (Cycle 1) | Number of Participants With Adverse Events | 74 Participants |
| BOTOX (Cycle 2) | Number of Participants With Adverse Events | 46 Participants |
| BOTOX (Cycle 3) | Number of Participants With Adverse Events | 26 Participants |
| BOTOX (Cycle 4) | Number of Participants With Adverse Events | 11 Participants |
| BOTOX (All Treatment Cycles) | Number of Participants With Adverse Events | 111 Participants |
| Total | Number of Participants With Adverse Events | 127 Participants |