A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With 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: NCT04994535
• Other study ID #: M21-310
• Secondary ID: 2021-000240-22
• Status: Completed
• Phase: Phase 3
• Start date: August 10, 2021
• Est. completion date: June 14, 2023

Study information

• Verified date: September 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• 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
Belgium	UZ Brussel /ID# 229125	Jette	Bruxelles-Capitale
Belgium	Duinbergen Clinic /ID# 231282	Knokke-Heist	West-Vlaanderen
Belgium	Medical Skincare /ID# 229129	Sint-Truiden	Limburg
Canada	Beacon Dermatology Inc /ID# 231675	Calgary	Alberta
Canada	Sweat Clinics of Canada /ID# 231021	Toronto	Ontario
Canada	Pacific Derm /ID# 231019	Vancouver	British Columbia
Canada	Bertucci MedSpa Inc. /ID# 231020	Woodbridge	Ontario
Germany	Rosenpark Research /ID# 229568	Darmstadt	Hessen
Germany	Noahklinik GmbH /ID# 232311	Kassel
Germany	Hautok and Hautok-cosmetics /ID# 229573	Muenchen
Germany	Privatpraxis fuer Dermatologie und Aesthetik /ID# 230901	Muenchen
Germany	Studienzentrum Theatiner46 /ID# 229570	Muenchen	Bayern
United Kingdom	Waverley Medical Practice /ID# 229590	Coatbridge
United Kingdom	MediZen Premier Aesthetic Clinic /ID# 229588	Sutton Coldfield
United States	DermResearch, Inc. Austin, TX /ID# 249904	Austin	Texas
United States	Bellaire Dermatology Associates /ID# 249902	Bellaire	Texas
United States	BOYD Beauty Birmingham /ID# 231190	Birmingham	Michigan
United States	Total Skin and Beauty Derm Ctr /ID# 249905	Birmingham	Alabama
United States	Coastal Clinical Research Center of the Carolinas /ID# 231197	Charleston	South Carolina
United States	DeNova Research /ID# 231191	Chicago	Illinois
United States	Michigan Center for Research Corporation /ID# 249911	Clinton Township	Michigan
United States	Skin Research Institute LLC /ID# 231195	Coral Gables	Florida
United States	Austin Institute for Clinical Research at SBA Dermatology /ID# 232104	Houston	Texas
United States	Skin Care and Laser Physicians of Beverly Hills /ID# 231194	Los Angeles	California
United States	Westside Aesthetics /ID# 231196	Los Angeles	California
United States	Skin and Cancer Associates, LLP /ID# 231189	Miami	Florida
United States	The Center for Dermatology Cosmetics & Laser Surgery /ID# 231187	Mount Kisco	New York
United States	Oak Dermatology in Naperville /ID# 231193	Naperville	Illinois
United States	Tennessee Clinical Research Center /ID# 244720	Nashville	Tennessee
United States	Etre Cosmetic Dermatology and Laser Center /ID# 231192	New Orleans	Louisiana
United States	Luxurgery /ID# 244924	New York	New York
United States	Skin Specialists, PC /ID# 249903	Omaha	Nebraska
United States	Austin Institute for Clinical Research /ID# 244936	Pflugerville	Texas
United States	Moradi MD /ID# 244719	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  United Kingdom, 

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 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.	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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