BOTOX for the Treatment of Platysma Prominence

• Status: Completed
• Trial end date: 2020-04-16
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of BOTOX in adults with moderate to severe platysma prominence

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period

• A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:

1. Not a woman of childbearing potential (WOCBP) OR

2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this study's protocol

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

• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

• Females who are pregnant, nursing, or planning a pregnancy during the study

• Known immunization or hypersensitivity to any botulinum toxin serotype

• History of alcohol or drug abuse within 12 months of the study

• Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck