Phase 3
N=408
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
Platysma Prominence
Bottom Line
View on ClinicalTrials.gov: NCT04949399 ↗Enrolled (actual)
408
Serious AEs
1.2%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With Adverse Events — 45; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OnabotulinumtoxinA (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
45; 47 | — |
| PRIMARY 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 |
1.9; 32.3 | <.0001 sig |
| PRIMARY 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 |
3.9; 43.8 | <0.0001 sig |
| PRIMARY 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 |
3.9; 45.6 | <0.0001 sig |
| SECONDARY 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 |
5.8; 56.9; 6.7; 44.1; 6.7; 23.8 | — |
| SECONDARY 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 |
5.1; 51.7; 7.1; 45.1; 6.4; 33.4 | — |
| SECONDARY 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 |
11.1; 65.9 | <.0001 sig |
| SECONDARY 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 |
14.7; 53.9 | <.0001 sig |
| SECONDARY 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 |
5.4; 50.6 | <0.0001 sig |
| SECONDARY Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 |
-2.1; -7.8 | <0.0001 sig |
| SECONDARY 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 |
19.0; 80.1; 21.4; 75.0; 19.8; 58.5 | — |
| SECONDARY 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 |
23.2; 80.5; 23.2; 78.2; 22.6; 69.7 | — |
| SECONDARY 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 |
5.2; 51.4 | <0.0001 sig |
| SECONDARY Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 |
11.7; 63.6 | <0.0001 sig |
| SECONDARY 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 |
11.3; 51.5 | <0.0001 sig |
| SECONDARY Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90 |
-2.8; -8.4; -2.7; -7.7; -2.4; -6.3 | <0.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT04949399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.