BOTOX® for the Treatment of Platysma Prominence

Platysma Prominence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915067
• Other study ID #: 1936-201-008
• Status: Completed
• Phase: Phase 2
• Start date: April 23, 2019
• Est. completion date: April 16, 2020

Study information

• Verified date: April 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platysma Prominence

Intervention

Drug:
• BOTOX® purified neurotoxin complex
BOTOX® superficial intramuscular injections.
• Placebo
Placebo injections.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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.	Day 14
Primary	Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)	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.	From the first dose of study drug up to end of study (up to Day 120)
Primary	Pulse Rate at Baseline	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline (Day 1)
Primary	Change From Baseline in Pulse Rate at Day 7	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 7
Primary	Change From Baseline in Pulse Rate at Day 14	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 14
Primary	Change From Baseline in Pulse Rate at Day 30	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 30
Primary	Change From Baseline in Pulse Rate at Day 60	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 60
Primary	Change From Baseline in Pulse Rate at Day 90	Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.	Baseline; Day 90
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.	Baseline; Day 120
Primary	Systolic and Diastolic Blood Pressure (BP) at Baseline	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline (Day 1)
Primary	Change From Baseline in Systolic and Diastolic BP at Day 7	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 7
Primary	Change From Baseline in Systolic and Diastolic BP at Day 14	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 14
Primary	Change From Baseline in Systolic and Diastolic BP at Day 30	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 30
Primary	Change From Baseline in Systolic and Diastolic BP at Day 60	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 60
Primary	Change From Baseline in Systolic and Diastolic BP at Day 90	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 90
Primary	Change From Baseline in Systolic and Diastolic BP at Day 120	Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.	Baseline; Day 120
Primary	Respiratory Rate at Baseline	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline (Day 1)
Primary	Change From Baseline in Respiratory Rate at Day 7	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 7
Primary	Change From Baseline in Respiratory Rate at Day 14	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 14
Primary	Change From Baseline in Respiratory Rate at Day 30	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 30
Primary	Change From Baseline in Respiratory Rate at Day 60	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 60
Primary	Change From Baseline in Respiratory Rate at Day 90	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 90
Primary	Change From Baseline in Respiratory Rate at Day 120	Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.	Baseline; Day 120
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)	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.	Day 14

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