NCT05134649
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.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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
