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

Platysma Prominence Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949399
• Other study ID #: M21-309
• Status: Completed
• Phase: Phase 3
• Start date: July 8, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: November 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 either intramuscular injections of onabotulinumtoxinA (BOTOX) or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 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 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

Related Conditions & MeSH terms

• Platysma Prominence

Intervention

Drug:
• OnabotulinumtoxinA
Injection
• Placebo
Injection

Locations

Country	Name	City	State
Canada	Dermetics Cosmetic Dermatology /ID# 229482	Burlington	Ontario
Canada	Dr Melinda Gooderham Medicine Profession /ID# 229456	Cobourg	Ontario
Canada	The Center For Dermatology /ID# 229481	Richmond Hill	Ontario
Canada	Humphrey Cosmetic Dermatology /ID# 229522	Vancouver	British Columbia
United States	SkinDC /ID# 229251	Arlington	Virginia
United States	Aesthetic Center at Woodholme /ID# 229836	Baltimore	Maryland
United States	Susan H. Weinkle MD /ID# 229419	Bradenton	Florida
United States	Aesthetic Solutions /ID# 229241	Chapel Hill	North Carolina
United States	Dallas Plastic Surgery Institute /ID# 229258	Dallas	Texas
United States	Aventiv Research Dublin /ID# 229254	Dublin	Ohio
United States	Clinical Testing of Beverly Hills /ID# 229946	Encino	California
United States	Advanced Research Associates - Glendale /ID# 229256	Glendale	Arizona
United States	Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260	Hunt Valley	Maryland
United States	Laser and Skin Surgery Center of Indiana /ID# 229515	Indianapolis	Indiana
United States	Dermatology Research Associates /ID# 229949	Los Angeles	California
United States	Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414	Metairie	Louisiana
United States	Image Dermatology, P.C. /ID# 229244	Montclair	New Jersey
United States	Nashville Center for Laser and Facial Surgery /ID# 229237	Nashville	Tennessee
United States	Delricht Research /ID# 229248	New Orleans	Louisiana
United States	Laser & Skin Surgery Center of New York /ID# 229423	New York	New York
United States	Steve Yoelin MD Medical Associate Inc /ID# 229420	Newport Beach	California
United States	KGL Skin Study Center, LLC /ID# 229253	Newtown Square	Pennsylvania
United States	Cosmetic Laser Dermatology /ID# 229245	San Diego	California
United States	Ava T. Shamban MD - Santa Monica. /ID# 229421	Santa Monica	California
United States	Clear Dermatology & Aesthetics Center /ID# 229252	Scottsdale	Arizona
United States	Art of Skin MD /ID# 229255	Solana Beach	California
United States	Premier Clinical Research /ID# 229261	Spokane	Washington
United States	Research Institute of the Southeast, LLC /ID# 229234	West Palm Beach	Florida
United States	DMR Research PLLC /ID# 229938	Westport	Connecticut
United States	Wilmington Dermatology Center /ID# 229246	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.	Day -14 to Day 120
Primary	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	The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme.; The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.	Day 1 to Day 14
Secondary	Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) according to Investigator's Assessment using C-APPS	The C-APPS evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1- Minimal to 5- Extreme.	Day 1 to Day 120
Secondary	Percentage of Participants who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment using P-APPS	The P-APPS evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.	Day 1 to Day 120
Secondary	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)	The ANLFQ is a 11-item measure that assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face.	Day 14
Secondary	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)	The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).	Day 14
Secondary	Percentage of Participants with Responses of 'Not at all Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands)	The BAS-PP Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).	Day 14
Secondary	Change from baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts summary score	The Appearance of Neck and Lower Face Questionnaire: Impacts is a 7-item measure that assesses the psychosocial impact of the appearance of the neck and lower face.	Day 1 to Day 14
Secondary	Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Investigator's Assessment Using C-APPS	The C-APPS evaluates platysma prominence and is a static measurement encompassing visual examination of the platysma muscle ranging from 1 - Minimal to 5- Extreme.	Day 1 to Day 120
Secondary	Percentage of Participants who Achieved at Least 1-Grade Improvement from Baseline Based on Participant's Assessment using P-APPS	The P-APPS evaluates platysma prominence and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.	Day 1 to Day 120

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