A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Public ClinicalTrials.gov record NCT04994535. 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 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.
Study identification
- NCT ID
- NCT04994535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 426 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
- Aug 10, 2021 (Actual)
- Primary completion
- Jun 14, 2023 (Actual)
- Completion
- Jun 14, 2023 (Actual)
- Last update posted
- Aug 20, 2024
2021 – 2023
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Derm Ctr /ID# 249905 | Birmingham | Alabama | 35205 | — |
| Westside Aesthetics /ID# 231196 | Los Angeles | California | 90025-1708 | — |
| Skin Care and Laser Physicians of Beverly Hills /ID# 231194 | Los Angeles | California | 90069 | — |
| Moradi MD /ID# 244719 | Vista | California | 92083-6030 | — |
| Skin Research Institute LLC /ID# 231195 | Coral Gables | Florida | 33146-1837 | — |
| Skin and Cancer Associates, LLP /ID# 231189 | Miami | Florida | 33137-3254 | — |
| DeNova Research /ID# 231191 | Chicago | Illinois | 60611 | — |
| Oak Dermatology in Naperville /ID# 231193 | Naperville | Illinois | 60563-3018 | — |
| Etre Cosmetic Dermatology and Laser Center /ID# 231192 | New Orleans | Louisiana | 70130-4353 | — |
| BOYD Beauty Birmingham /ID# 231190 | Birmingham | Michigan | 48009-6301 | — |
| Michigan Center for Research Corporation /ID# 249911 | Clinton Township | Michigan | 48038 | — |
| Skin Specialists, PC /ID# 249903 | Omaha | Nebraska | 68144 | — |
| The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187 | Mount Kisco | New York | 10549-3028 | — |
| Luxurgery /ID# 244924 | New York | New York | 10021-4951 | — |
| Coastal Clinical Research Center of the Carolinas /ID# 231197 | Charleston | South Carolina | 29414 | — |
| Tennessee Clinical Research Center /ID# 244720 | Nashville | Tennessee | 37215-2885 | — |
| DermResearch, Inc. Austin, TX /ID# 249904 | Austin | Texas | 78759 | — |
| Bellaire Dermatology Associates /ID# 249902 | Bellaire | Texas | 77401 | — |
| Austin Institute for Clinical Research at SBA Dermatology /ID# 232104 | Houston | Texas | 77056-4129 | — |
| Austin Institute for Clinical Research /ID# 244936 | Pflugerville | Texas | 78660 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04994535, 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 Aug 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 NCT04994535 live on ClinicalTrials.gov.