A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

NCT04994535 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M21-3102021-000240-22
• Study Type: interventional
• Target: 426
• Locations: 5 countries
• Sites: 34

Brief Summary

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence. Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK. Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study. Participants will attend regular monthly visits during the study at the study site.

Conditions

Platysma Prominence

Keywords

Platysma Prominence; OnabotulinumtoxinA; BOTOX

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events

  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.

  Enrollment to Day 120

• Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14

  The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.

  Day 14

• Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14

  The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.

  Day 14

• Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self-Assessment Using P-APPS at Maximum Contraction at Day 14

  The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.

  Day 14

Secondary Outcomes (12)

• Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120

  Day 14, 30, 60, 90, and 120

• Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Self-Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120

  Day 14, 30, 60, 90, and 120

• Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14

  Day 14

• Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14

  Day 14

• Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14

  Day 14

Study Arms (2)

BOTOX

EXPERIMENTAL

BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle on Day 1

Drug: OnabotulinumtoxinA

Placebo

PLACEBO COMPARATOR

Placebo will be injected into the platysma muscle on Day 1

Drug: Placebo

Interventions

OnabotulinumtoxinA DRUG

Injection

Also known as: BOTOX

BOTOX

Placebo DRUG

Saline injection

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures
• Are willing and able to comply with procedures required in the protocol
• Adult male or female, at least 18 years old at the time of signing the informed consent
• Good health as determined by medical history, physical examination, vital signs, and investigator's judgment

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
• Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study
• Known immunization or hypersensitivity to any botulinum toxin serotype
• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months
• Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)
• Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest

Sponsors & Collaborators

• AbbVie: lead

Study Sites (34)

Total Skin and Beauty Derm Ctr /ID# 249905

Birmingham, Alabama, 35205, United States

Location

Westside Aesthetics /ID# 231196

Los Angeles, California, 90025-1708, United States

Location

Skin Care and Laser Physicians of Beverly Hills /ID# 231194

Los Angeles, California, 90069, United States

Location

Moradi MD /ID# 244719

Vista, California, 92083-6030, United States

Location

Skin Research Institute LLC /ID# 231195

Coral Gables, Florida, 33146-1837, United States

Location

Skin and Cancer Associates, LLP /ID# 231189

Miami, Florida, 33137-3254, United States

Location

DeNova Research /ID# 231191

Chicago, Illinois, 60611, United States

Location

Oak Dermatology in Naperville /ID# 231193

Naperville, Illinois, 60563-3018, United States

Location

Etre Cosmetic Dermatology and Laser Center /ID# 231192

New Orleans, Louisiana, 70130-4353, United States

Location

BOYD Beauty Birmingham /ID# 231190

Birmingham, Michigan, 48009-6301, United States

Location

Michigan Center for Research Corporation /ID# 249911

Clinton Township, Michigan, 48038, United States

Location

Skin Specialists, PC /ID# 249903

Omaha, Nebraska, 68144, United States

Location

The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187

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

Location

Luxurgery /ID# 244924

New York, New York, 10021-4951, United States

Location

Coastal Clinical Research Center of the Carolinas /ID# 231197

Charleston, South Carolina, 29414, United States

Location

Tennessee Clinical Research Center /ID# 244720

Nashville, Tennessee, 37215-2885, United States

Location

DermResearch, Inc. Austin, TX /ID# 249904

Austin, Texas, 78759, United States

Location

Bellaire Dermatology Associates /ID# 249902

Bellaire, Texas, 77401, United States

Location

Austin Institute for Clinical Research at SBA Dermatology /ID# 232104

Houston, Texas, 77056-4129, United States

Location

Austin Institute for Clinical Research /ID# 244936

Pflugerville, Texas, 78660, United States

Location

UZ Brussel /ID# 229125

Jette, Brussels Capital, 1090, Belgium

Location

Medical Skincare /ID# 229129

Sint-Truiden, Limburg, 3800, Belgium

Location

Duinbergen Clinic /ID# 231282

Knokke-Heist, West-Vlaanderen, 8301, Belgium

Location

Beacon Dermatology Inc /ID# 231675

Calgary, Alberta, T3E 0B2, Canada

Location

Pacific Derm /ID# 231019

Vancouver, British Columbia, V6H 4E1, Canada

Location

Sweat Clinics of Canada /ID# 231021

Toronto, Ontario, M5R 3N8, Canada

Location

Bertucci MedSpa Inc. /ID# 231020

Woodbridge, Ontario, L4L 8E2, Canada

Location

Studienzentrum Theatiner46 /ID# 229570

Munich, Bavaria, 80333, Germany

Location

Rosenpark Research /ID# 229568

Darmstadt, Hesse, 64283, Germany

Location

Noahklinik GmbH /ID# 232311

Kassel, 34117, Germany

Location

Hautok and Hautok-cosmetics /ID# 229573

München, 80333, Germany

Location

Privatpraxis fuer Dermatologie und Aesthetik /ID# 230901

München, 80539, Germany

Location

Waverley Medical Practice /ID# 229590

Coatbridge, ML5 3AP, United Kingdom

Location

MediZen Premier Aesthetic Clinic /ID# 229588

Sutton Coldfield, B74 2UG, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: August 10, 2021
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

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

US (20); CA (4); BE (3); DE (5); GB (2)