Clinical trial NCT05134649: A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platysma Prominence
Keywords: Platysma Prominence
BOTOX
OnabotulinumtoxinA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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
* Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 231997
state: Arizona
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center /ID# 231990
state: Arizona
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills /ID# 231986
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Assoc. Inc /ID# 232004
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 232414
state: California
city: Santa Monica
country: United States
facility: Ava T. Shamban MD - Santa Monica. /ID# 232000
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD /ID# 231995
state: California
city: Westport
country: United States
facility: DMR Research PLLC /ID# 231998
state: Connecticut
city: Bradenton
country: United States
facility: Susan H. Weinkle MD /ID# 232001
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC /ID# 231974
state: Florida
city: Indianapolis
country: United States
facility: Laser and Skin Surgery Center of Indiana /ID# 231983
state: Indiana
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research /ID# 231985
state: Louisiana
city: Baltimore
country: United States
facility: Aesthetic Center at Woodholme /ID# 231996
state: Maryland
city: Hunt Valley
country: United States
facility: Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002
state: Maryland
city: Montclair
country: United States
facility: Image Dermatology, P.C. /ID# 231980
state: New Jersey
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York /ID# 231982
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions /ID# 231978
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 231981
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Dublin /ID# 231994
state: Ohio
city: Newtown Square
country: United States
facility: KGL Skin Study Center, LLC /ID# 231993
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery /ID# 231975
state: Tennessee
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 231999
state: Texas
city: Arlington
country: United States
facility: SkinDC /ID# 231989
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 232003
state: Washington
city: Vancouver
country: Canada
facility: Humphrey Cosmetic Dermatology /ID# 239649
state: British Columbia
city: Burlington
country: Canada
facility: Dermetics Cosmetic Dermatology /ID# 239650
state: Ontario
city: Cobourg
country: Canada
facility: Dr Melinda Gooderham Medicine Profession /ID# 239647
state: Ontario
city: Richmond Hill
country: Canada
facility: The Center For Dermatology /ID# 239651
state: Ontario
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: