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

Conditions

• Platysma Prominence

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• OnabotulinumtoxinA — DRUG
  Intramuscular Injection

Study Details

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.

Key Dates

First listed

Nov 26, 2021

Start date

Nov 16, 2021

Status verified

Nov 2024

Primary completion

Aug 18, 2023

Completion

Aug 18, 2023

Study Design

Enrollment

292 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323) ]

Locations (25)

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