Clinical trial NCT04994535: A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With 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: 2021-08-06
Enrollment: 426
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 across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.

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 Self-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: Birmingham
country: United States
facility: Total Skin and Beauty Derm Ctr /ID# 249905
state: Alabama
city: Los Angeles
country: United States
facility: Westside Aesthetics /ID# 231196
state: California
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills /ID# 231194
state: California
city: Vista
country: United States
facility: Moradi MD /ID# 244719
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 231195
state: Florida
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 231189
state: Florida
city: Chicago
country: United States
facility: DeNova Research /ID# 231191
state: Illinois
city: Naperville
country: United States
facility: Oak Dermatology in Naperville /ID# 231193
state: Illinois
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center /ID# 231192
state: Louisiana
city: Birmingham
country: United States
facility: BOYD Beauty Birmingham /ID# 231190
state: Michigan
city: Clinton Township
country: United States
facility: Michigan Center for Research Corporation /ID# 249911
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 249903
state: Nebraska
city: Mount Kisco
country: United States
facility: The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187
state: New York
city: New York
country: United States
facility: Luxurgery /ID# 244924
state: New York
city: Charleston
country: United States
facility: Coastal Clinical Research Center of the Carolinas /ID# 231197
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center /ID# 244720
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc. Austin, TX /ID# 249904
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates /ID# 249902
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research at SBA Dermatology /ID# 232104
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 244936
state: Texas
city: Jette
country: Belgium
facility: UZ Brussel /ID# 229125
state: Bruxelles-Capitale
city: Sint-Truiden
country: Belgium
facility: Medical Skincare /ID# 229129
state: Limburg
city: Knokke-Heist
country: Belgium
facility: Duinbergen Clinic /ID# 231282
state: West-Vlaanderen
city: Calgary
country: Canada
facility: Beacon Dermatology Inc /ID# 231675
state: Alberta
city: Vancouver
country: Canada
facility: Pacific Derm /ID# 231019
state: British Columbia
city: Toronto
country: Canada
facility: Sweat Clinics of Canada /ID# 231021
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa Inc. /ID# 231020
state: Ontario
city: Muenchen
country: Germany
facility: Studienzentrum Theatiner46 /ID# 229570
state: Bayern
city: Darmstadt
country: Germany
facility: Rosenpark Research /ID# 229568
state: Hessen
city: Kassel
country: Germany
facility: Noahklinik GmbH /ID# 232311
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics /ID# 229573
city: Muenchen
country: Germany
facility: Privatpraxis fuer Dermatologie und Aesthetik /ID# 230901
city: Coatbridge
country: United Kingdom
facility: Waverley Medical Practice /ID# 229590
city: Sutton Coldfield
country: United Kingdom
facility: MediZen Premier Aesthetic Clinic /ID# 229588
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: