A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Public ClinicalTrials.gov record NCT05134649. 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
Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety 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.
This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study. Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.
Study identification
- NCT ID
- NCT05134649
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 292 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
- Nov 16, 2021 (Actual)
- Primary completion
- Aug 18, 2023 (Actual)
- Completion
- Aug 18, 2023 (Actual)
- Last update posted
- Dec 5, 2024
2021 – 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 231997 | Glendale | Arizona | 85308 | — |
| Clear Dermatology & Aesthetics Center /ID# 231990 | Scottsdale | Arizona | 85255-4134 | — |
| Clinical Testing of Beverly Hills /ID# 231986 | Encino | California | 91436-2124 | — |
| Steve Yoelin MD Medical Assoc. Inc /ID# 232004 | Newport Beach | California | 92663-3311 | — |
| Cosmetic Laser Dermatology /ID# 232414 | San Diego | California | 92121-2119 | — |
| Ava T. Shamban MD - Santa Monica. /ID# 232000 | Santa Monica | California | 90404-2208 | — |
| Art of Skin MD /ID# 231995 | Solana Beach | California | 92075-2228 | — |
| DMR Research PLLC /ID# 231998 | Westport | Connecticut | 06880-5369 | — |
| Susan H. Weinkle MD /ID# 232001 | Bradenton | Florida | 34209-5642 | — |
| Research Institute of the Southeast, LLC /ID# 231974 | West Palm Beach | Florida | 33401-2712 | — |
| Laser and Skin Surgery Center of Indiana /ID# 231983 | Indianapolis | Indiana | 46260-2386 | — |
| Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977 | Metairie | Louisiana | 70006 | — |
| Delricht Research /ID# 231985 | New Orleans | Louisiana | 70115 | — |
| Aesthetic Center at Woodholme /ID# 231996 | Baltimore | Maryland | 21208-6391 | — |
| Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002 | Hunt Valley | Maryland | 21030-3216 | — |
| Image Dermatology, P.C. /ID# 231980 | Montclair | New Jersey | 07042 | — |
| Laser & Skin Surgery Center of New York /ID# 231982 | New York | New York | 10016-4974 | — |
| Aesthetic Solutions /ID# 231978 | Chapel Hill | North Carolina | 27517-9901 | — |
| Wilmington Dermatology Center /ID# 231981 | Wilmington | North Carolina | 28403 | — |
| Aventiv Research Dublin /ID# 231994 | Dublin | Ohio | 43016 | — |
| KGL Skin Study Center, LLC /ID# 231993 | Newtown Square | Pennsylvania | 19073-2228 | — |
| Nashville Center for Laser and Facial Surgery /ID# 231975 | Nashville | Tennessee | 37203-1513 | — |
| Dallas Plastic Surgery Institute /ID# 231999 | Dallas | Texas | 75231 | — |
| SkinDC /ID# 231989 | Arlington | Virginia | 22209 | — |
| Premier Clinical Research /ID# 232003 | 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 NCT05134649, 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 Dec 5, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05134649 live on ClinicalTrials.gov.