Phase 2
N=171
BOTOX® for the Treatment of Platysma Prominence
Platysma Prominence
Bottom Line
View on ClinicalTrials.gov: NCT03915067 ↗Enrolled (actual)
171
Serious AEs
1.2%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) — 12.0; 77.8; 88.2 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BOTOX® purified neurotoxin complex (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) |
12.0; 77.8; 88.2 | <0.0001 sig |
| PRIMARY Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE) |
13; 14; 14 | — |
| PRIMARY Pulse Rate at Baseline |
73.0; 74.4; 73.6 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 7 |
1.0; -0.5; 1.2 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 14 |
0.4; -1.4; 1.3 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 30 |
0.1; -0.9; -0.5 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 60 |
0.4; 0.3; -2.1 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 90 |
1.1; -0.9; 0.0 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 120 |
0.5; -0.4; 0.8 | — |
| PRIMARY Systolic and Diastolic Blood Pressure (BP) at Baseline |
116.6; 119.7; 120.4; 77.2; 76.6; 77.6 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic BP at Day 7 |
1.2; 1.7; -2.0; -0.5; 0.3; 0.2 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic BP at Day 14 |
0.0; 1.9; -1.7; -1.0; 1.1; -0.5 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic BP at Day 30 |
-2.0; -0.7; -2.8; -1.3; 0.6; -0.8 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic BP at Day 60 |
-1.2; 2.2; -2.6; -0.4; 1.9; -2.4 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic BP at Day 90 |
1.4; -0.3; -2.7; -2.4; 0.6; -3.2 | — |
| PRIMARY Change From Baseline in Systolic and Diastolic BP at Day 120 |
0.6; 0.1; -1.3; -0.7; -0.4; -0.5 | — |
| PRIMARY Respiratory Rate at Baseline |
15.6; 15.5; 15.6 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Day 7 |
-0.1; 0.1; -0.2 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Day 14 |
-0.2; -0.1; 0.0 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Day 30 |
-0.3; 0.5; 0.0 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Day 60 |
-0.2; -0.1; 0.2 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Day 90 |
-0.3; -0.1; -0.2 | — |
| PRIMARY Change From Baseline in Respiratory Rate at Day 120 |
-0.7; -0.2; -0.3 | — |
| SECONDARY Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS) |
18.0; 75.9; 88.2 | <0.0001 sig |
Summary
To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.
Eligibility Criteria
Inclusion Criteria
- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
- A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol
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
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- Females who are pregnant, nursing, or planning a pregnancy during the study
- Known immunization or hypersensitivity to any botulinum toxin serotype
- History of alcohol or drug abuse within 12 months of the study
- Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck
Data sourced from ClinicalTrials.gov (NCT03915067). 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.