BOTOX® for the Treatment of Platysma Prominence

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03915067

Enrollment

171

Registered

2019-04-16

Start date

2019-04-23

Completion date

2020-04-16

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platysma Prominence

Brief summary

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Interventions

DRUGBOTOX® purified neurotoxin complex

BOTOX® superficial intramuscular injections.

DRUGPlacebo

Placebo injections.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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: 1. Not a woman of childbearing potential (WOCBP) OR 2. 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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Respiratory Rate at Day 120	Baseline; Day 120	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
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)	Day 14	The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)	From the first dose of study drug up to end of study (up 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. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.
Pulse Rate at Baseline	Baseline (Day 1)	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 7	Baseline; Day 7	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 14	Baseline; Day 14	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 30	Baseline; Day 30	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 60	Baseline; Day 60	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 90	Baseline; Day 90	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 120	Baseline; Day 120	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Systolic and Diastolic Blood Pressure (BP) at Baseline	Baseline (Day 1)	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 7	Baseline; Day 7	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 14	Baseline; Day 14	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 30	Baseline; Day 30	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 60	Baseline; Day 60	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 90	Baseline; Day 90	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 120	Baseline; Day 120	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Respiratory Rate at Baseline	Baseline (Day 1)	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 7	Baseline; Day 7	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 14	Baseline; Day 14	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 30	Baseline; Day 30	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 60	Baseline; Day 60	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 90	Baseline; Day 90	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Secondary

Measure	Time frame	Description
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)	Day 14	The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.

Countries

Canada, United States

Participant flow

Pre-assignment details

Participant flow and all-cause mortality tables are based on all participants randomized on Day 1. Adverse events are reported for safety population, which included all participants who were administered study intervention.

Participants by arm

Arm	Count
Placebo Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.	53
BOTOX® Low Dose Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.	58
BOTOX® High Dose Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.	53
Total	164

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1
Overall Study	Covid-19 Related Issues	2	4	4
Overall Study	Lost to Follow-up	3	2	0
Overall Study	Protocol Deviation	0	0	1
Overall Study	Randomized With Incorrect C-APPS	1	0	0
Overall Study	Withdrawal by Subject	4	3	0

Baseline characteristics

Characteristic	Placebo	BOTOX® Low Dose	BOTOX® High Dose	Total
Age, Continuous	49.3 years STANDARD_DEVIATION 9.59	51.8 years STANDARD_DEVIATION 9.16	48.6 years STANDARD_DEVIATION 10.21	50.0 years STANDARD_DEVIATION 9.69
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants	6 Participants	6 Participants	17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants	52 Participants	47 Participants	147 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	3 Participants	5 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	1 Participants	0 Participants	3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	49 Participants	56 Participants	49 Participants	154 Participants
Sex: Female, Male Female	52 Participants	54 Participants	50 Participants	156 Participants
Sex: Female, Male Male	1 Participants	4 Participants	3 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 57	0 / 59	0 / 55
other Total, other adverse events	10 / 56	6 / 59	8 / 54
serious Total, serious adverse events	0 / 56	2 / 59	0 / 54

Outcome results

Primary

Change From Baseline in Pulse Rate at Day 120

Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

Time frame: Baseline; Day 120