Platysma Prominence Clinical Trial
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
Verified date | May 2024 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 3, open-label study to evaluate the safety of BOTOX Injection in Adult Participants with Platysma Prominence
Status | Completed |
Enrollment | 292 |
Est. completion date | August 18, 2023 |
Est. primary completion date | August 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit) Exclusion Criteria: - Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function - Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention) - Anticipated need for surgery or overnight hospitalization during the study - Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study - Known immunization or hypersensitivity to any botulinum toxin serotype - History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months - Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable) - Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest |
Country | Name | City | State |
---|---|---|---|
Canada | Dermetics Cosmetic Dermatology /ID# 239650 | Burlington | Ontario |
Canada | Dr Melinda Gooderham Medicine Profession /ID# 239647 | Cobourg | Ontario |
Canada | The Center For Dermatology /ID# 239651 | Richmond Hill | Ontario |
Canada | Humphrey Cosmetic Dermatology /ID# 239649 | Vancouver | British Columbia |
United States | SkinDC /ID# 231989 | Arlington | Virginia |
United States | Aesthetic Center at Woodholme /ID# 231996 | Baltimore | Maryland |
United States | Susan H. Weinkle MD /ID# 232001 | Bradenton | Florida |
United States | Aesthetic Solutions /ID# 231978 | Chapel Hill | North Carolina |
United States | Dallas Plastic Surgery Institute /ID# 231999 | Dallas | Texas |
United States | Aventiv Research Dublin /ID# 231994 | Dublin | Ohio |
United States | Clinical Testing of Beverly Hills /ID# 231986 | Encino | California |
United States | Advanced Research Associates - Glendale /ID# 231997 | Glendale | Arizona |
United States | Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002 | Hunt Valley | Maryland |
United States | Laser and Skin Surgery Center of Indiana /ID# 231983 | Indianapolis | Indiana |
United States | Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977 | Metairie | Louisiana |
United States | Image Dermatology, P.C. /ID# 231980 | Montclair | New Jersey |
United States | Nashville Center for Laser and Facial Surgery /ID# 231975 | Nashville | Tennessee |
United States | Delricht Research /ID# 231985 | New Orleans | Louisiana |
United States | Laser & Skin Surgery Center of New York /ID# 231982 | New York | New York |
United States | Steve Yoelin MD Medical Assoc. Inc /ID# 232004 | Newport Beach | California |
United States | KGL Skin Study Center, LLC /ID# 231993 | Newtown Square | Pennsylvania |
United States | Cosmetic Laser Dermatology /ID# 232414 | San Diego | California |
United States | Ava T. Shamban MD - Santa Monica. /ID# 232000 | Santa Monica | California |
United States | Clear Dermatology & Aesthetics Center /ID# 231990 | Scottsdale | Arizona |
United States | Art of Skin MD /ID# 231995 | Solana Beach | California |
United States | Premier Clinical Research /ID# 232003 | Spokane | Washington |
United States | Research Institute of the Southeast, LLC /ID# 231974 | West Palm Beach | Florida |
United States | DMR Research PLLC /ID# 231998 | Westport | Connecticut |
United States | Wilmington Dermatology Center /ID# 231981 | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events | 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. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug. | Day 1 to Day 240 |
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