Overview

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

Status:
Enrolling by invitation

Trial end date:
2023-06-20

Target enrollment:
0

Participant gender:
All

Summary

This is a Phase 3, open-label study to evaluate the safety of BOTOX Injection in Adult Participants with Platysma Prominence

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Allergan

Criteria

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

- Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that
may interfere with photography (such that photograph is not acceptable)

- Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area
of interest