A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
Public ClinicalTrials.gov record NCT04949399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04949399
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 408 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2021 (Actual)
- Primary completion
- Dec 20, 2022 (Actual)
- Completion
- Dec 20, 2022 (Actual)
- Last update posted
- Nov 20, 2024
2021 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 229256 | Glendale | Arizona | 85308 | — |
| Clear Dermatology & Aesthetics Center /ID# 229252 | Scottsdale | Arizona | 85255-4134 | — |
| Clinical Testing of Beverly Hills /ID# 229946 | Encino | California | 91436-2124 | — |
| Dermatology Research Associates /ID# 229949 | Los Angeles | California | 90045 | — |
| Steve Yoelin MD Medical Associate Inc /ID# 229420 | Newport Beach | California | 92663 | — |
| Cosmetic Laser Dermatology /ID# 229245 | San Diego | California | 92121-2119 | — |
| Ava T. Shamban MD - Santa Monica. /ID# 229421 | Santa Monica | California | 90404-2208 | — |
| Art of Skin MD /ID# 229255 | Solana Beach | California | 92075-2228 | — |
| DMR Research PLLC /ID# 229938 | Westport | Connecticut | 06880 | — |
| Susan H. Weinkle MD /ID# 229419 | Bradenton | Florida | 34209-5642 | — |
| Research Institute of the Southeast, LLC /ID# 229234 | West Palm Beach | Florida | 33401-2712 | — |
| Laser and Skin Surgery Center of Indiana /ID# 229515 | Indianapolis | Indiana | 46260-2386 | — |
| Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414 | Metairie | Louisiana | 70006 | — |
| Delricht Research /ID# 229248 | New Orleans | Louisiana | 70115 | — |
| Aesthetic Center at Woodholme /ID# 229836 | Baltimore | Maryland | 21208-6391 | — |
| Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260 | Hunt Valley | Maryland | 21030-3216 | — |
| Image Dermatology, P.C. /ID# 229244 | Montclair | New Jersey | 07042 | — |
| Laser & Skin Surgery Center of New York /ID# 229423 | New York | New York | 10016-4974 | — |
| Aesthetic Solutions /ID# 229241 | Chapel Hill | North Carolina | 27517-9901 | — |
| Wilmington Dermatology Center /ID# 229246 | Wilmington | North Carolina | 28403 | — |
| Aventiv Research Dublin /ID# 229254 | Dublin | Ohio | 43016 | — |
| KGL Skin Study Center, LLC /ID# 229253 | Newtown Square | Pennsylvania | 19073-2228 | — |
| Nashville Center for Laser and Facial Surgery /ID# 229237 | Nashville | Tennessee | 37203-1513 | — |
| Dallas Plastic Surgery Institute /ID# 229258 | Dallas | Texas | 75231 | — |
| SkinDC /ID# 229251 | Arlington | Virginia | 22209 | — |
| Premier Clinical Research /ID# 229261 | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04949399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04949399 live on ClinicalTrials.gov.