A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence

Completed · Phase 3 · Has a placebo group

Conditions studied: Platysma Prominence

In brief

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study in the United States and Canada. Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Participants will attend regular monthly visits during the study at the study site.

Key facts

Study ID

NCT04949399

Run by

AbbVie

People needed

408

Starts

2021-07-08

Expected to finish

2022-12-20

Last updated by the study team

2024-11-20

Who can join

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

You may qualify if…

• Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures
• Are willing and able to comply with procedures required in the protocol
• Adult male or female, at least 18 years old at the time of signing the informed consent
• Good health as determined by medical history, physical examination, vital signs, and investigator's judgment

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
• 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

Where it is running

• Advanced Research Associates - Glendale /ID# 229256 — Glendale, Arizona, United States
• Clear Dermatology & Aesthetics Center /ID# 229252 — Scottsdale, Arizona, United States
• Clinical Testing of Beverly Hills /ID# 229946 — Encino, California, United States
• Dermatology Research Associates /ID# 229949 — Los Angeles, California, United States
• Steve Yoelin MD Medical Associate Inc /ID# 229420 — Newport Beach, California, United States
• Cosmetic Laser Dermatology /ID# 229245 — San Diego, California, United States
• Ava T. Shamban MD - Santa Monica. /ID# 229421 — Santa Monica, California, United States
• Art of Skin MD /ID# 229255 — Solana Beach, California, United States
• DMR Research PLLC /ID# 229938 — Westport, Connecticut, United States
• Susan H. Weinkle MD /ID# 229419 — Bradenton, Florida, United States
• Research Institute of the Southeast, LLC /ID# 229234 — West Palm Beach, Florida, United States
• Laser and Skin Surgery Center of Indiana /ID# 229515 — Indianapolis, Indiana, United States
• Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414 — Metairie, Louisiana, United States
• Delricht Research /ID# 229248 — New Orleans, Louisiana, United States
• Aesthetic Center at Woodholme /ID# 229836 — Baltimore, Maryland, United States
• Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260 — Hunt Valley, Maryland, United States
• Image Dermatology, P.C. /ID# 229244 — Montclair, New Jersey, United States
• Laser & Skin Surgery Center of New York /ID# 229423 — New York, New York, United States
• Aesthetic Solutions /ID# 229241 — Chapel Hill, North Carolina, United States
• Wilmington Dermatology Center /ID# 229246 — Wilmington, North Carolina, United States
• Aventiv Research Dublin /ID# 229254 — Dublin, Ohio, United States
• KGL Skin Study Center, LLC /ID# 229253 — Newtown Square, Pennsylvania, United States
• Nashville Center for Laser and Facial Surgery /ID# 229237 — Nashville, Tennessee, United States
• Dallas Plastic Surgery Institute /ID# 229258 — Dallas, Texas, United States
• SkinDC /ID# 229251 — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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