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NCT04949399 · ClinicalTrials.gov registry record · Phase 3
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
A Phase 3 study of Platysma Prominence, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 408
- Enrollment target
- 20
- Study locations
NCT04949399: Completed Phase 3 study of Platysma Prominence, sponsored by AbbVie.
NCT04949399 is a Phase 3 study of Platysma Prominence that has completed, run by AbbVie. The registered enrollment target is 408 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04949399, a Phase 3 study of Platysma Prominence, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 408 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 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.
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 casual relationship with this treatment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OnabotulinumtoxinA
Study Locations (20)
California
- Clinical Testing of Beverly Hills /ID# 229946 - Encino
- Dermatology Research Associates /ID# 229949 - Los Angeles
- Steve Yoelin MD Medical Associate Inc /ID# 229420 - Newport Beach
- Cosmetic Laser Dermatology /ID# 229245 - San Diego
- Ava T. Shamban MD - Santa Monica. /ID# 229421 - Santa Monica
- Art of Skin MD /ID# 229255 - Solana Beach
Arizona
- Advanced Research Associates - Glendale /ID# 229256 - Glendale
- Clear Dermatology & Aesthetics Center /ID# 229252 - Scottsdale
Florida
- Susan H. Weinkle MD /ID# 229419 - Bradenton
- Research Institute of the Southeast, LLC /ID# 229234 - West Palm Beach
Louisiana
- Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414 - Metairie
- Delricht Research /ID# 229248 - New Orleans
Maryland
- Aesthetic Center at Woodholme /ID# 229836 - Baltimore
- Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260 - Hunt Valley
North Carolina
- Aesthetic Solutions /ID# 229241 - Chapel Hill
- Wilmington Dermatology Center /ID# 229246 - Wilmington
Connecticut
- DMR Research PLLC /ID# 229938 - Westport
Indiana
- Laser and Skin Surgery Center of Indiana /ID# 229515 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 3 |
What the finished NCT04949399 record still lists
NCT04949399 is an interventional study that assigns participants to a tested intervention. The registered 408 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 (47% 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.
NCT04949399 names 20 study sites across 10 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04949399 about?
NCT04949399 is a clinical study titled "A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe 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 NCT04949399?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2021-07-08. Estimated completion is 2022-12-20.
What conditions does trial NCT04949399 study?
This clinical trial studies the following conditions: Platysma Prominence.
What interventions are being tested in trial NCT04949399?
The interventions under investigation include: Placebo (DRUG), OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT04949399?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04949399 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04949399's enrollment target sits among peer trials
408 911th of 2000 higher than 1,088 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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