A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With 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 across approximately 35 sites in USA, Belgium, Canada, Germany and the UK. 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

NCT04994535

Run by

AbbVie

People needed

426

Starts

2021-08-10

Expected to finish

2023-06-14

Last updated by the study team

2024-08-20

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

• Total Skin and Beauty Derm Ctr /ID# 249905 — Birmingham, Alabama, United States
• Westside Aesthetics /ID# 231196 — Los Angeles, California, United States
• Skin Care and Laser Physicians of Beverly Hills /ID# 231194 — Los Angeles, California, United States
• Moradi MD /ID# 244719 — Vista, California, United States
• Skin Research Institute LLC /ID# 231195 — Coral Gables, Florida, United States
• Skin and Cancer Associates, LLP /ID# 231189 — Miami, Florida, United States
• DeNova Research /ID# 231191 — Chicago, Illinois, United States
• Oak Dermatology in Naperville /ID# 231193 — Naperville, Illinois, United States
• Etre Cosmetic Dermatology and Laser Center /ID# 231192 — New Orleans, Louisiana, United States
• BOYD Beauty Birmingham /ID# 231190 — Birmingham, Michigan, United States
• Michigan Center for Research Corporation /ID# 249911 — Clinton Township, Michigan, United States
• Skin Specialists, PC /ID# 249903 — Omaha, Nebraska, United States
• The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187 — Mount Kisco, New York, United States
• Luxurgery /ID# 244924 — New York, New York, United States
• Coastal Clinical Research Center of the Carolinas /ID# 231197 — Charleston, South Carolina, United States
• Tennessee Clinical Research Center /ID# 244720 — Nashville, Tennessee, United States
• DermResearch, Inc. Austin, TX /ID# 249904 — Austin, Texas, United States
• Bellaire Dermatology Associates /ID# 249902 — Bellaire, Texas, United States
• Austin Institute for Clinical Research at SBA Dermatology /ID# 232104 — Houston, Texas, United States
• Austin Institute for Clinical Research /ID# 244936 — Pflugerville, Texas, United States
• UZ Brussel /ID# 229125 — Jette, Brussels Capital, Belgium
• Medical Skincare /ID# 229129 — Sint-Truiden, Limburg, Belgium
• Duinbergen Clinic /ID# 231282 — Knokke-Heist, West-Vlaanderen, Belgium
• Beacon Dermatology Inc /ID# 231675 — Calgary, Alberta, Canada
• Pacific Derm /ID# 231019 — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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