A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
- Registration Number
- NCT04949399
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
- 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) was 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 casual relationship with this treatment.
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 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.
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 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).
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).
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 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 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 visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
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.
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.
Trial Locations
- Locations (30)
Laser and Skin Surgery Center of Indiana /ID# 229515
🇺🇸Indianapolis, Indiana, United States
Advanced Research Associates - Glendale /ID# 229256
🇺🇸Glendale, Arizona, United States
Clinical Testing of Beverly Hills /ID# 229946
🇺🇸Encino, California, United States
Aesthetic Center at Woodholme /ID# 229836
🇺🇸Baltimore, Maryland, United States
Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414
🇺🇸Metairie, Louisiana, United States
Image Dermatology, P.C. /ID# 229244
🇺🇸Montclair, New Jersey, United States
Aesthetic Solutions /ID# 229241
🇺🇸Chapel Hill, North Carolina, United States
Dr Melinda Gooderham Medicine Profession /ID# 229456
🇨🇦Cobourg, Ontario, Canada
Nashville Center for Laser and Facial Surgery /ID# 229237
🇺🇸Nashville, Tennessee, United States
Dermatology Research Associates /ID# 229949
🇺🇸Los Angeles, California, United States
Clear Dermatology & Aesthetics Center /ID# 229252
🇺🇸Scottsdale, Arizona, United States
Cosmetic Laser Dermatology /ID# 229245
🇺🇸San Diego, California, United States
Art of Skin MD /ID# 229255
🇺🇸Solana Beach, California, United States
DMR Research PLLC /ID# 229938
🇺🇸Westport, Connecticut, United States
Susan H. Weinkle MD /ID# 229419
🇺🇸Bradenton, Florida, United States
Research Institute of the Southeast, LLC /ID# 229234
🇺🇸West Palm Beach, Florida, United States
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260
🇺🇸Hunt Valley, Maryland, United States
Laser & Skin Surgery Center of New York /ID# 229423
🇺🇸New York, New York, United States
Aventiv Research Dublin /ID# 229254
🇺🇸Dublin, Ohio, United States
Wilmington Dermatology Center /ID# 229246
🇺🇸Wilmington, North Carolina, United States
KGL Skin Study Center, LLC /ID# 229253
🇺🇸Newtown Square, Pennsylvania, United States
The Center For Dermatology /ID# 229481
🇨🇦Richmond Hill, Ontario, Canada
Dallas Plastic Surgery Institute /ID# 229258
🇺🇸Dallas, Texas, United States
Humphrey Cosmetic Dermatology /ID# 229522
🇨🇦Vancouver, British Columbia, Canada
SkinDC /ID# 229251
🇺🇸Arlington, Virginia, United States
Dermetics Cosmetic Dermatology /ID# 229482
🇨🇦Burlington, Ontario, Canada
Steve Yoelin MD Medical Associate Inc /ID# 229420
🇺🇸Newport Beach, California, United States
Delricht Research /ID# 229248
🇺🇸New Orleans, Louisiana, United States
Ava T. Shamban MD - Santa Monica. /ID# 229421
🇺🇸Santa Monica, California, United States
Premier Clinical Research /ID# 229261
🇺🇸Spokane, Washington, United States