BOTOX® for the Treatment of Platysma Prominence

Phase 2CompletedNCT03915067

Allergan171 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

171

Conditions

Platysma Prominence

Interventions

BOTOX® purified neurotoxin complexDRUG

BOTOX® superficial intramuscular injections.

PlaceboDRUG

Placebo injections.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Skin Care and Laser Physicians of Beverly Hills /ID# 236518

Los Angeles, California, United States

Skin Research Institute LLC /ID# 238126

Coral Gables, Florida, United States

DeNova Research /ID# 238165

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 14

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.

Time frame: From the first dose of study drug up to end of study (up to Day 120)

Pulse Rate at Baseline

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

Time frame: Baseline (Day 1)

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.

Time frame: Baseline; Day 7

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.

Time frame: Baseline; Day 14

Data from ClinicalTrials.gov

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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

The Practice of Brian S. Biesman MD PLLC /ID# 234461

Nashville, Tennessee, United States

Dallas Plastic Surgery Institute /ID# 236528

Dallas, Texas, United States

Humphrey Cosmetic Dermatology /ID# 236591

Vancouver, British Columbia, Canada

Pacific Derm /ID# 238236

Vancouver, British Columbia, Canada

Dermetics Cosmetic Dermatology /ID# 236899

Burlington, Ontario, Canada

...and 2 more locations

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.

Time frame: Baseline; Day 30

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.

Time frame: Baseline; Day 60

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.

Time frame: Baseline; Day 90

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

Systolic and Diastolic Blood Pressure (BP) at Baseline