BOTOX® for the Treatment of Platysma Prominence

NCT03915067 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1936-201-008
• Study Type: interventional
• Target: 171
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

Platysma Prominence

Outcome Measures

Primary Outcomes (23)

• 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

• 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)

• Pulse Rate at Baseline

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  Baseline; Day 120

• 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)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.

Drug: Placebo

BOTOX® Low Dose

EXPERIMENTAL

Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.

Drug: BOTOX® purified neurotoxin complex

BOTOX® High Dose

ACTIVE COMPARATOR

Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.

Drug: BOTOX® purified neurotoxin complex

Interventions

BOTOX® purified neurotoxin complex DRUG

BOTOX® superficial intramuscular injections.

Also known as: Botulinum toxin type A purified neurotoxin complex

BOTOX® High Dose; BOTOX® Low Dose

Placebo DRUG

Placebo injections.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Not a woman of childbearing potential (WOCBP) OR
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (12)

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

Los Angeles, California, 90069, United States

Location

Skin Research Institute LLC /ID# 238126

Coral Gables, Florida, 33146-1837, United States

Location

DeNova Research /ID# 238165

Chicago, Illinois, 60611, United States

Location

MD Laser Skin & Vein /ID# 234532

Hunt Valley, Maryland, 21030, United States

Location

The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624

Mount Kisco, New York, 10549-3028, United States

Location

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

Nashville, Tennessee, 37203, United States

Location

Dallas Plastic Surgery Institute /ID# 236528

Dallas, Texas, 75231, United States

Location

Humphrey Cosmetic Dermatology /ID# 236591

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Derm /ID# 238236

Vancouver, British Columbia, V6H 4E1, Canada

Location

Dermetics Cosmetic Dermatology /ID# 236899

Burlington, Ontario, L7N 3N2, Canada

Location

Sweat Clinics of Canada /ID# 236590

Toronto, Ontario, M5R 3N8, Canada

Location

Bertucci MedSpa Inc. /ID# 236523

Woodbridge, Ontario, L4L 8E2, Canada

Location

Related Publications (2)

• Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31.

  PMID: 40704633 DERIVED

• Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16.

  PMID: 38640068 DERIVED

Related Links

• Related Info

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 16, 2019
• Study Start: April 23, 2019
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: May 3, 2023
• Results First Posted: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

CA (5); US (7)