Clinical trial NCT03915067: BOTOX® for the Treatment of Platysma Prominence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Platysma Prominence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

  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

Primary outcomes:
measure: 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)
timeFrame: Day 14
measure: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
timeFrame: From the first dose of study drug up to end of study (up to Day 120)
measure: Pulse Rate at Baseline
timeFrame: Baseline (Day 1)
measure: Change From Baseline in Pulse Rate at Day 7
timeFrame: Baseline; Day 7
measure: Change From Baseline in Pulse Rate at Day 14
timeFrame: Baseline; Day 14
measure: Change From Baseline in Pulse Rate at Day 30
timeFrame: Baseline; Day 30
measure: Change From Baseline in Pulse Rate at Day 60
timeFrame: Baseline; Day 60
measure: Change From Baseline in Pulse Rate at Day 90
timeFrame: Baseline; Day 90
measure: Change From Baseline in Pulse Rate at Day 120
timeFrame: Baseline; Day 120
measure: Systolic and Diastolic Blood Pressure (BP) at Baseline
timeFrame: Baseline (Day 1)
measure: Change From Baseline in Systolic and Diastolic BP at Day 7
timeFrame: Baseline; Day 7
measure: Change From Baseline in Systolic and Diastolic BP at Day 14
timeFrame: Baseline; Day 14
measure: Change From Baseline in Systolic and Diastolic BP at Day 30
timeFrame: Baseline; Day 30
measure: Change From Baseline in Systolic and Diastolic BP at Day 60
timeFrame: Baseline; Day 60
measure: Change From Baseline in Systolic and Diastolic BP at Day 90
timeFrame: Baseline; Day 90
measure: Change From Baseline in Systolic and Diastolic BP at Day 120
timeFrame: Baseline; Day 120
measure: Respiratory Rate at Baseline
timeFrame: Baseline (Day 1)
measure: Change From Baseline in Respiratory Rate at Day 7
timeFrame: Baseline; Day 7
measure: Change From Baseline in Respiratory Rate at Day 14
timeFrame: Baseline; Day 14
measure: Change From Baseline in Respiratory Rate at Day 30
timeFrame: Baseline; Day 30
measure: Change From Baseline in Respiratory Rate at Day 60
timeFrame: Baseline; Day 60
measure: Change From Baseline in Respiratory Rate at Day 90
timeFrame: Baseline; Day 90
measure: Change From Baseline in Respiratory Rate at Day 120
timeFrame: Baseline; Day 120
Secondary outcomes:
measure: 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)
timeFrame: Day 14
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Skin Care and Laser Physicians of Beverly Hills /ID# 236518
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute LLC /ID# 238126
state: Florida
city: Chicago
country: United States
facility: DeNova Research /ID# 238165
state: Illinois
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein /ID# 234532
state: Maryland
city: Mount Kisco
country: United States
facility: The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624
state: New York
city: Nashville
country: United States
facility: The Practice of Brian S. Biesman MD PLLC /ID# 234461
state: Tennessee
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute /ID# 236528
state: Texas
city: Vancouver
country: Canada
facility: Humphrey Cosmetic Dermatology /ID# 236591
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm /ID# 238236
state: British Columbia
city: Burlington
country: Canada
facility: Dermetics Cosmetic Dermatology /ID# 236899
state: Ontario
city: Toronto
country: Canada
facility: Sweat Clinics of Canada /ID# 236590
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa Inc. /ID# 236523
state: Ontario
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: