A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
- Registration Number
- NCT04994535
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BOTOX OnabotulinumtoxinA BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1 Placebo Placebo Placebo will be injected into the platysma muscle on Day 1
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events Enrollment to Day 120 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 causal relationship with this treatment.
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 Day 14 The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
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 Day 14 The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.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 Day 14 The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
- Secondary Outcome Measures
Name Time Method 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 Day 14, 30, 60, 90, and 120 The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
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 Day 14, 30, 60, 90, and 120 The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
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 Day 14 The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
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 Day 14 The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 Day 14 The ANLFQ: Impacts scale assesses the psychosocial impact due to the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.
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 Day 14, 30, 60, 90, and 120 The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
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 Day 14 The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 Day 14 The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
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 Day 14 The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 Days 30, 60, and 90 The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.
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 Day 14, 30, 60, 90, and 120 The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
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 Day 14 The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (34)
Westside Aesthetics /ID# 231196
🇺🇸Los Angeles, California, United States
DeNova Research /ID# 231191
🇺🇸Chicago, Illinois, United States
Skin and Cancer Associates, LLP /ID# 231189
🇺🇸Miami, Florida, United States
Austin Institute for Clinical Research at SBA Dermatology /ID# 232104
🇺🇸Houston, Texas, United States
Luxurgery /ID# 244924
🇺🇸New York, New York, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 231194
🇺🇸Los Angeles, California, United States
Rosenpark Research /ID# 229568
🇩🇪Darmstadt, Hessen, Germany
BOYD Beauty Birmingham /ID# 231190
🇺🇸Birmingham, Michigan, United States
Sweat Clinics of Canada /ID# 231021
🇨🇦Toronto, Ontario, Canada
MediZen Premier Aesthetic Clinic /ID# 229588
🇬🇧Sutton Coldfield, United Kingdom
Michigan Center for Research Corporation /ID# 249911
🇺🇸Clinton Township, Michigan, United States
Austin Institute for Clinical Research /ID# 244936
🇺🇸Pflugerville, Texas, United States
Noahklinik GmbH /ID# 232311
🇩🇪Kassel, Germany
Beacon Dermatology Inc /ID# 231675
🇨🇦Calgary, Alberta, Canada
UZ Brussel /ID# 229125
🇧🇪Jette, Bruxelles-Capitale, Belgium
Medical Skincare /ID# 229129
🇧🇪Sint-Truiden, Limburg, Belgium
Pacific Derm /ID# 231019
🇨🇦Vancouver, British Columbia, Canada
The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187
🇺🇸Mount Kisco, New York, United States
Skin Research Institute LLC /ID# 231195
🇺🇸Coral Gables, Florida, United States
Moradi MD /ID# 244719
🇺🇸Vista, California, United States
Oak Dermatology in Naperville /ID# 231193
🇺🇸Naperville, Illinois, United States
Bellaire Dermatology Associates /ID# 249902
🇺🇸Bellaire, Texas, United States
Duinbergen Clinic /ID# 231282
🇧🇪Knokke-Heist, West-Vlaanderen, Belgium
Bertucci MedSpa Inc. /ID# 231020
🇨🇦Woodbridge, Ontario, Canada
Studienzentrum Theatiner46 /ID# 229570
🇩🇪Muenchen, Bayern, Germany
Hautok and Hautok-cosmetics /ID# 229573
🇩🇪Muenchen, Germany
Waverley Medical Practice /ID# 229590
🇬🇧Coatbridge, United Kingdom
Privatpraxis fuer Dermatologie und Aesthetik /ID# 230901
🇩🇪Muenchen, Germany
DermResearch, Inc. Austin, TX /ID# 249904
🇺🇸Austin, Texas, United States
Total Skin and Beauty Derm Ctr /ID# 249905
🇺🇸Birmingham, Alabama, United States
Etre Cosmetic Dermatology and Laser Center /ID# 231192
🇺🇸New Orleans, Louisiana, United States
Skin Specialists, PC /ID# 249903
🇺🇸Omaha, Nebraska, United States
Tennessee Clinical Research Center /ID# 244720
🇺🇸Nashville, Tennessee, United States
Coastal Clinical Research Center of the Carolinas /ID# 231197
🇺🇸Charleston, South Carolina, United States