A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

AbbVie

Status and phase: Completed; Phase 3

Conditions: Platysma Prominence

Treatments: Drug: OnabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05134649

M21-323

Details and patient eligibility

About

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.

Enrollment: 292 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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292 participants in 1 patient group

BOTOX

Experimental group

Description:

BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323

Treatment:

Drug: OnabotulinumtoxinA