A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134649
• Other study ID #: M21-323
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2021
• Est. completion date: August 18, 2023

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, open-label study to evaluate the safety of BOTOX Injection in Adult Participants with Platysma Prominence

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Platysma Prominence

Intervention

Drug:
• BOTOX
Intramuscular Injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.