BOTOX® for the Treatment of Platysma Prominence

Completed · Phase 2 · Has a placebo group

Conditions studied: Platysma Prominence

In brief

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

Key facts

Study ID

NCT03915067

Run by

Allergan

People needed

171

Starts

2019-04-23

Expected to finish

2020-04-16

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Not a woman of childbearing potential (WOCBP) OR
• 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 informed consent form (ICF) and in this study's protocol

You may not qualify if…

• 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

Where it is running

• Skin Care and Laser Physicians of Beverly Hills /ID# 236518 — Los Angeles, California, United States
• Skin Research Institute LLC /ID# 238126 — Coral Gables, Florida, United States
• DeNova Research /ID# 238165 — Chicago, Illinois, United States
• MD Laser Skin & Vein /ID# 234532 — Hunt Valley, Maryland, United States
• The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624 — Mount Kisco, New York, United States
• The Practice of Brian S. Biesman MD PLLC /ID# 234461 — Nashville, Tennessee, United States
• Dallas Plastic Surgery Institute /ID# 236528 — Dallas, Texas, United States
• Humphrey Cosmetic Dermatology /ID# 236591 — Vancouver, British Columbia, Canada
• Pacific Derm /ID# 238236 — Vancouver, British Columbia, Canada
• Dermetics Cosmetic Dermatology /ID# 236899 — Burlington, Ontario, Canada
• Sweat Clinics of Canada /ID# 236590 — Toronto, Ontario, Canada
• Bertucci MedSpa Inc. /ID# 236523 — Woodbridge, Ontario, Canada

Full record on ClinicalTrials.gov

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