BOTOX® for the Treatment of Platysma Prominence

Phase 2

Completed

Conditions: Platysma Prominence

Interventions: Drug: BOTOX® purified neurotoxin complex
Drug: Placebo

Registration Number: NCT03915067

Lead Sponsor: Allergan

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 171

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BOTOX® High Dose	BOTOX® purified neurotoxin complex	Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® Low Dose	BOTOX® purified neurotoxin complex	Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
Placebo	Placebo	Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12): Dallas Plastic Surgery Institute /ID# 236528
🇺🇸
Dallas, Texas, United States
Sweat Clinics of Canada /ID# 236590
🇨🇦
Toronto, Ontario, Canada
Pacific Derm /ID# 238236
🇨🇦
Vancouver, British Columbia, Canada
Dermetics Cosmetic Dermatology /ID# 236899
🇨🇦
Burlington, Ontario, Canada
MD Laser Skin & Vein /ID# 234532
🇺🇸
Hunt Valley, Maryland, United States
The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624
🇺🇸
Mount Kisco, New York, United States
Skin Care and Laser Physicians of Beverly Hills /ID# 236518
🇺🇸
Los Angeles, California, United States
Humphrey Cosmetic Dermatology /ID# 236591
🇨🇦
Vancouver, British Columbia, Canada
Bertucci MedSpa Inc. /ID# 236523
🇨🇦
Woodbridge, Ontario, Canada
The Practice of Brian S. Biesman MD PLLC /ID# 234461
🇺🇸
Nashville, Tennessee, United States
Skin Research Institute LLC /ID# 238126
🇺🇸
Coral Gables, Florida, United States
DeNova Research /ID# 238165
🇺🇸
Chicago, Illinois, United States