A Phase 3 interventional study of OnabotulinumtoxinA and Placebo in Platysma Prominence, sponsored by AbbVie. Completed at 34 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1
Drug: OnabotulinumtoxinA
Placebo will be injected into the platysma muscle on Day 1
Drug: Placebo
Injection
Also known as: BOTOX
Saline injection
Number of Participants With Adverse Events
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.
Time frame: Enrollment to Day 120
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
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.
Time frame: Day 14
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
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.
Time frame: Day 14
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
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.
Time frame: Day 14
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
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.
Time frame: Day 14, 30, 60, 90, and 120
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
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.
Time frame: Day 14, 30, 60, 90, and 120
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
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).
Time frame: Day 14
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
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).
Time frame: Day 14
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
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).
Time frame: Day 14
Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at 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.
Time frame: Day 14
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
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.
Time frame: Day 14, 30, 60, 90, and 120
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
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.
Time frame: Day 14, 30, 60, 90, and 120
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
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.
Time frame: Day 14
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at 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).
Time frame: Day 14
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
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).
Time frame: Day 14
Change From Baseline on the ANLFQ: Impacts Summary Score at 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.
Time frame: Days 30, 60, and 90
A total of 426 participants were enrolled and randomized into the study (ITT Population); 209 to BOTOX and 217 to placebo. A total of 208 participants were treated with BOTOX and 216 participants were treated with placebo (Safety Analysis Set). A total of 381 participants were included in the modified ITT (mITT) Population; 186 to BOTOX and 195 to placebo. A participant was considered to have completed the study if he/she had at least completed the treatment visit and the end of study visit.
| Milestone | Placebo | BOTOX |
|---|---|---|
| Started | 217 | 209 |
| Completed | 199 | 194 |
| Not completed | 18 | 15 |
| Withdrew: Lost to follow-up | 7 | 7 |
| Withdrew: Withdrawal by subject | 10 | 7 |
| Withdrew: Other | 1 | 1 |
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.
| Participants | Placebo | BOTOX |
|---|---|---|
| Number of Participants With Adverse Events | 43 | 34 |
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.
| percentage of participants | Placebo | BOTOX |
|---|---|---|
| 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 | 0.5 (NA to NA) | 31.4 (25.0 to 37.8) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 | 2.2 (0 to 4.3) | 41.0 (33.8 to 48.3) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 (1.1 to 6.7) | 40.8 (33.5 to 48.1) |
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 | Placebo | BOTOX |
|---|---|---|
| Day 14 | 3.0 (0.6 to 5.3) | 48.3 (41.3 to 55.3) |
| Day 30 | 3.3 (0.9 to 5.8) | 43.8 (36.9 to 50.7) |
| Day 60 | 4.5 (1.6 to 7.3) | 24.8 (18.8 to 30.8) |
| Day 90 | 2.0 (0.1 to 3.9) | 15.2 (10.2 to 20.1) |
| Day 120 | 2.5 (0.4 to 4.7) | 14.0 (9.2 to 18.8) |
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 | Placebo | BOTOX |
|---|---|---|
| Day 14 | 5.1 (2.1 to 8.2) | 47.1 (40.2 to 54.1) |
| Day 30 | 5.6 (2.4 to 8.8) | 41.0 (34.2 to 47.8) |
| Day 60 | 7.1 (3.5 to 10.6) | 28.8 (22.4 to 35.2) |
| Day 90 | 3.6 (1.0 to 6.2) | 20.6 (14.9 to 26.3) |
| Day 120 | 3.8 (1.2 to 6.3) | 16.7 (11.5 to 21.9) |
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).
| percent of participants | Placebo | BOTOX |
|---|---|---|
| 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 | 12.0 (7.4 to 16.5) | 62.1 (55.4 to 68.9) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 | 23.1 (17.3 to 28.9) | 50.2 (43.3 to 57.1) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 | 14.4 (9.5 to 19.2) | 50.2 (43.3 to 57.1) |
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.
| score on a scale | Placebo | BOTOX |
|---|---|---|
| Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | -2.7 ± 0.45 | -7.1 ± 0.46 |
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 | Placebo | BOTOX |
|---|---|---|
| Day 14 | 20.1 (14.5 to 25.7) | 76.9 (71.0 to 82.7) |
| Day 30 | 18.7 (13.2 to 24.3) | 72.6 (66.4 to 78.8) |
| Day 60 | 19.5 (13.9 to 25.1) | 54.9 (47.7 to 62.0) |
| Day 90 | 17.3 (12.0 to 22.7) | 44.0 (37.0 to 50.9) |
| Day 120 | 14.9 (10.0 to 19.9) | 33.9 (27.4 to 40.5) |
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 | Placebo | BOTOX |
|---|---|---|
| Day 14 | 21.0 (15.3 to 26.6) | 79.3 (73.6 to 84.9) |
| Day 30 | 22.8 (17.0 to 28.6) | 73.9 (67.8 to 80.0) |
| Day 60 | 20.9 (15.3 to 26.5) | 65.2 (58.6 to 71.9) |
| Day 90 | 18.6 (12.9 to 24.2) | 53.7 (46.6 to 60.7) |
| Day 120 | 18.8 (13.2 to 24.3) | 42.9 (36.0 to 49.7) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 (1.9 to 8.4) | 48.1 (40.7 to 55.5) |
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 | Placebo | BOTOX |
|---|---|---|
| Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14 | 11.8 (7.0 to 16.6) | 61.2 (54.0 to 68.4) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 | 20.6 (14.7 to 26.4) | 49.4 (42.1 to 56.7) |
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 | Placebo | BOTOX |
|---|---|---|
| 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 | 11.9 (7.2 to 16.6) | 47.8 (40.5 to 55.1) |
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.
| score on a scale | Placebo | BOTOX |
|---|---|---|
| Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14 | -3.0 ± 0.50 | -7.7 ± 0.51 |
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.
| score on a scale | Placebo | BOTOX |
|---|---|---|
| Day 30 | -3.9 ± 0.54 | -8.8 ± 0.55 |
| Day 60 | -3.5 ± 0.56 | -8.2 ± 0.56 |
| Day 90 | -3.5 ± 0.50 | -7.4 ± 0.50 |
Collected over All-cause mortality and adverse event tables include events reported from enrollment to end of study. The median time participants were followed was 120 days for both the BOTOX and Placebo treatment groups.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/216 (0%) | 1/216 (0.5%) | 6/216 (2.8%) |
| BOTOX | 0/208 (0%) | 0/208 (0%) | 7/208 (3.4%) |
| Event | Placebo | BOTOX |
|---|---|---|
| ADNEXA UTERI CYSTReproductive system and breast disorders | 1/216 | 0/208 |
| Event | Placebo | BOTOX |
|---|---|---|
| COVID-19Infections and infestations | 6/216 | 7/208 |
Baseline analyses were performed on the ITT population, consisting of all randomized participants.
| Age, Continuous(years) | Placebo | BOTOX (onabotulinumtoxinA) | Total |
|---|---|---|---|
| Mean | 46.9 ± 10.18 | 48.0 ± 9.57 | 47.5 ± 9.89 |
| Sex: Female, Male(Participants) | Placebo | BOTOX (onabotulinumtoxinA) | Total |
|---|---|---|---|
| Female | 206 | 198 | 404 |
| Male | 11 | 11 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | BOTOX (onabotulinumtoxinA) | Total |
|---|---|---|---|
| Hispanic or Latino | 35 | 30 | 65 |
| Not Hispanic or Latino | 182 | 179 | 361 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | BOTOX (onabotulinumtoxinA) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 8 | 11 | 19 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 202 | 191 | 393 |
| More than one race | 2 | 4 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
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