BOTOX® for the Treatment of Platysma Prominence

April 11, 2023 updated by: Allergan

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Humphrey Cosmetic Dermatology /ID# 236591
      • Vancouver, British Columbia, Canada, V6H 4E1
        • Pacific Derm /ID# 238236
    • Ontario
      • Burlington, Ontario, Canada, L7N 3N2
        • Dermetics Cosmetic Dermatology /ID# 236899
      • Toronto, Ontario, Canada, M5R 3N8
        • Sweat Clinics of Canada /ID# 236590
      • Woodbridge, Ontario, Canada, L4L 8E2
        • Bertucci MedSpa Inc. /ID# 236523
  • United States
    • California
      • Los Angeles, California, United States, 90069
        • Skin Care and Laser Physicians of Beverly Hills /ID# 236518
    • Florida
      • Coral Gables, Florida, United States, 33146-1837
        • Skin Research Institute LLC /ID# 238126
    • Illinois
      • Chicago, Illinois, United States, 60611
        • DeNova Research /ID# 238165
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • MD Laser Skin & Vein /ID# 234532
    • New York
      • Mount Kisco, New York, United States, 10549-3028
        • The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Practice of Brian S. Biesman MD PLLC /ID# 234461
    • Texas
      • Dallas, Texas, United States, 75231
        • Dallas Plastic Surgery Institute /ID# 236528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
Drug: Placebo
Placebo injections.
Experimental: BOTOX® Low Dose
Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
Drug: BOTOX® purified neurotoxin complex
BOTOX® superficial intramuscular injections.
Other Names:
  • Botulinum toxin type A purified neurotoxin complex
Active Comparator: BOTOX® High Dose
Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
Drug: BOTOX® purified neurotoxin complex
BOTOX® superficial intramuscular injections.
Other Names:
  • Botulinum toxin type A purified neurotoxin complex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
Day 14
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
Time Frame: 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.
From the first dose of study drug up to end of study (up to Day 120)
Pulse Rate at Baseline
Time Frame: Baseline (Day 1)
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline (Day 1)
Change From Baseline in Pulse Rate at Day 7
Time Frame: Baseline; Day 7
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline; Day 7
Change From Baseline in Pulse Rate at Day 14
Time Frame: Baseline; Day 14
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline; Day 14
Change From Baseline in Pulse Rate at Day 30
Time Frame: Baseline; Day 30
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline; Day 30
Change From Baseline in Pulse Rate at Day 60
Time Frame: Baseline; Day 60
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline; Day 60
Change From Baseline in Pulse Rate at Day 90
Time Frame: Baseline; Day 90
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline; Day 90
Change From Baseline in Pulse Rate at Day 120
Time Frame: Baseline; Day 120
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Baseline; Day 120
Systolic and Diastolic Blood Pressure (BP) at Baseline
Time Frame: Baseline (Day 1)
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline (Day 1)
Change From Baseline in Systolic and Diastolic BP at Day 7
Time Frame: Baseline; Day 7
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline; Day 7
Change From Baseline in Systolic and Diastolic BP at Day 14
Time Frame: Baseline; Day 14
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline; Day 14
Change From Baseline in Systolic and Diastolic BP at Day 30
Time Frame: Baseline; Day 30
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline; Day 30
Change From Baseline in Systolic and Diastolic BP at Day 60
Time Frame: Baseline; Day 60
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline; Day 60
Change From Baseline in Systolic and Diastolic BP at Day 90
Time Frame: Baseline; Day 90
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline; Day 90
Change From Baseline in Systolic and Diastolic BP at Day 120
Time Frame: Baseline; Day 120
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Baseline; Day 120
Respiratory Rate at Baseline
Time Frame: Baseline (Day 1)
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Baseline (Day 1)
Change From Baseline in Respiratory Rate at Day 7
Time Frame: Baseline; Day 7
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Baseline; Day 7
Change From Baseline in Respiratory Rate at Day 14
Time Frame: Baseline; Day 14
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Baseline; Day 14
Change From Baseline in Respiratory Rate at Day 30
Time Frame: Baseline; Day 30
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Baseline; Day 30
Change From Baseline in Respiratory Rate at Day 60
Time Frame: Baseline; Day 60
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Baseline; Day 60
Change From Baseline in Respiratory Rate at Day 90
Time Frame: Baseline; Day 90
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Baseline; Day 90
Change From Baseline in Respiratory Rate at Day 120
Time Frame: Baseline; 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1936-201-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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