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

NCT04949399 | Completed Phase 3 Results FDA Drug

• 1 other identifier: M21-309
• Study Type: interventional
• Target: 408
• Locations: 2 countries
• Sites: 30

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 in the United States and Canada. 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 casual 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 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) was 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 (30)

Advanced Research Associates - Glendale /ID# 229256

Glendale, Arizona, 85308, United States

Location

Clear Dermatology & Aesthetics Center /ID# 229252

Scottsdale, Arizona, 85255-4134, United States

Location

Clinical Testing of Beverly Hills /ID# 229946

Encino, California, 91436-2124, United States

Location

Dermatology Research Associates /ID# 229949

Los Angeles, California, 90045, United States

Location

Steve Yoelin MD Medical Associate Inc /ID# 229420

Newport Beach, California, 92663, United States

Location

Cosmetic Laser Dermatology /ID# 229245

San Diego, California, 92121-2119, United States

Location

Ava T. Shamban MD - Santa Monica. /ID# 229421

Santa Monica, California, 90404-2208, United States

Location

Art of Skin MD /ID# 229255

Solana Beach, California, 92075-2228, United States

Location

DMR Research PLLC /ID# 229938

Westport, Connecticut, 06880, United States

Location

Susan H. Weinkle MD /ID# 229419

Bradenton, Florida, 34209-5642, United States

Location

Research Institute of the Southeast, LLC /ID# 229234

West Palm Beach, Florida, 33401-2712, United States

Location

Laser and Skin Surgery Center of Indiana /ID# 229515

Indianapolis, Indiana, 46260-2386, United States

Location

Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414

Metairie, Louisiana, 70006, United States

Location

Delricht Research /ID# 229248

New Orleans, Louisiana, 70115, United States

Location

Aesthetic Center at Woodholme /ID# 229836

Baltimore, Maryland, 21208-6391, United States

Location

Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260

Hunt Valley, Maryland, 21030-3216, United States

Location

Image Dermatology, P.C. /ID# 229244

Montclair, New Jersey, 07042, United States

Location

Laser & Skin Surgery Center of New York /ID# 229423

New York, New York, 10016-4974, United States

Location

Aesthetic Solutions /ID# 229241

Chapel Hill, North Carolina, 27517-9901, United States

Location

Wilmington Dermatology Center /ID# 229246

Wilmington, North Carolina, 28403, United States

Location

Aventiv Research Dublin /ID# 229254

Dublin, Ohio, 43016, United States

Location

KGL Skin Study Center, LLC /ID# 229253

Newtown Square, Pennsylvania, 19073-2228, United States

Location

Nashville Center for Laser and Facial Surgery /ID# 229237

Nashville, Tennessee, 37203-1513, United States

Location

Dallas Plastic Surgery Institute /ID# 229258

Dallas, Texas, 75231, United States

Location

SkinDC /ID# 229251

Arlington, Virginia, 22209, United States

Location

Premier Clinical Research /ID# 229261

Spokane, Washington, 99202, United States

Location

Humphrey Cosmetic Dermatology /ID# 229522

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Dermetics Cosmetic Dermatology /ID# 229482

Burlington, Ontario, L7N 3N2, Canada

Location

Dr Melinda Gooderham Medicine Profession /ID# 229456

Cobourg, Ontario, K9A 0Z4, Canada

Location

The Center For Dermatology /ID# 229481

Richmond Hill, Ontario, L4B 1A5, Canada

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: June 25, 2021
• First Posted: July 2, 2021
• Study Start: July 8, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

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 (4); US (26)