Clinical trial NCT04949399: A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platysma Prominence
Keywords: Platysma Prominence
OnabotulinumtoxinA
BOTOX
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 in the United States and Canada.

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.


Eligibility criteria: Inclusion Criteria:

* Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures
* Are willing and able to comply with procedures required in the protocol
* Adult male or female, at least 18 years old at the time of signing the informed consent
* Good health as determined by medical history, physical examination, vital signs, and investigator's judgment

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Enrollment to Day 120
measure: Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14
timeFrame: Day 14
measure: Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
timeFrame: Day 14
measure: Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14
timeFrame: Day 14
Secondary outcomes:
measure: Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
timeFrame: Day 14, 30, 60, 90, and 120
measure: Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
timeFrame: Day 14, 30, 60, 90, and 120
measure: Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
timeFrame: Day 14
measure: Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14
timeFrame: Day 14
measure: Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14
timeFrame: Day 14
measure: Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14
timeFrame: Day 14
measure: Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
timeFrame: Day 14, 30, 60, 90, and 120
measure: Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
timeFrame: Day 14, 30, 60, 90, and 120
measure: Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14
timeFrame: Day 14
measure: Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
timeFrame: Day 14
measure: Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14
timeFrame: Day 14
measure: Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90
timeFrame: Days 30, 60, and 90
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates - Glendale /ID# 229256
state: Arizona
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center /ID# 229252
state: Arizona
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills /ID# 229946
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates /ID# 229949
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin MD Medical Associate Inc /ID# 229420
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology /ID# 229245
state: California
city: Santa Monica
country: United States
facility: Ava T. Shamban MD - Santa Monica. /ID# 229421
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD /ID# 229255
state: California
city: Westport
country: United States
facility: DMR Research PLLC /ID# 229938
state: Connecticut
city: Bradenton
country: United States
facility: Susan H. Weinkle MD /ID# 229419
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC /ID# 229234
state: Florida
city: Indianapolis
country: United States
facility: Laser and Skin Surgery Center of Indiana /ID# 229515
state: Indiana
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research /ID# 229248
state: Louisiana
city: Baltimore
country: United States
facility: Aesthetic Center at Woodholme /ID# 229836
state: Maryland
city: Hunt Valley
country: United States
facility: Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260
state: Maryland
city: Montclair
country: United States
facility: Image Dermatology, P.C. /ID# 229244
state: New Jersey
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York /ID# 229423
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions /ID# 229241
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center /ID# 229246
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Dublin /ID# 229254
state: Ohio
city: Newtown Square
country: United States
facility: KGL Skin Study Center, LLC /ID# 229253
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery /ID# 229237
state: Tennessee
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 229258
state: Texas
city: Arlington
country: United States
facility: SkinDC /ID# 229251
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 229261
state: Washington
city: Vancouver
country: Canada
facility: Humphrey Cosmetic Dermatology /ID# 229522
state: British Columbia
city: Burlington
country: Canada
facility: Dermetics Cosmetic Dermatology /ID# 229482
state: Ontario
city: Cobourg
country: Canada
facility: Dr Melinda Gooderham Medicine Profession /ID# 229456
state: Ontario
city: Richmond Hill
country: Canada
facility: The Center For Dermatology /ID# 229481
state: Ontario
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: