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NCT04994535 · ClinicalTrials.gov registry record · Phase 3
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
A Phase 3 study of Platysma Prominence, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 426
- Enrollment target
- 20
- Study locations
NCT04994535: Completed Phase 3 study of Platysma Prominence, sponsored by AbbVie.
NCT04994535 is a Phase 3 study of Platysma Prominence that has completed, run by AbbVie. The registered enrollment target is 426 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04994535, a Phase 3 study of Platysma Prominence, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 426 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OnabotulinumtoxinA
Study Locations (20)
Texas
- DermResearch, Inc. Austin, TX /ID# 249904 - Austin
- Bellaire Dermatology Associates /ID# 249902 - Bellaire
- Austin Institute for Clinical Research at SBA Dermatology /ID# 232104 - Houston
- Austin Institute for Clinical Research /ID# 244936 - Pflugerville
California
- Westside Aesthetics /ID# 231196 - Los Angeles
- Skin Care and Laser Physicians of Beverly Hills /ID# 231194 - Los Angeles
- Moradi MD /ID# 244719 - Vista
Florida
- Skin Research Institute LLC /ID# 231195 - Coral Gables
- Skin and Cancer Associates, LLP /ID# 231189 - Miami
Illinois
- DeNova Research /ID# 231191 - Chicago
- Oak Dermatology in Naperville /ID# 231193 - Naperville
Michigan
- BOYD Beauty Birmingham /ID# 231190 - Birmingham
- Michigan Center for Research Corporation /ID# 249911 - Clinton Township
New York
- The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187 - Mount Kisco
- Luxurgery /ID# 244924 - New York
Alabama
- Total Skin and Beauty Derm Ctr /ID# 249905 - Birmingham
Louisiana
- Etre Cosmetic Dermatology and Laser Center /ID# 231192 - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2023-06-14 |
| Phase | Phase 3 |
What the finished NCT04994535 record still lists
NCT04994535 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Platysma Prominence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04994535 names 20 study sites across 11 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04994535 about?
NCT04994535 is a clinical study titled "A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence". 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 w...
What is the current status of trial NCT04994535?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 426 participants. The study started on 2021-08-10. Estimated completion is 2023-06-14.
What conditions does trial NCT04994535 study?
This clinical trial studies the following conditions: Platysma Prominence.
What interventions are being tested in trial NCT04994535?
The interventions under investigation include: Placebo (DRUG), OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT04994535?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04994535 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04994535's enrollment target sits among peer trials
426 882nd of 2000 higher than 1,118 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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