Clinical trial NCT06068855: A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants
Official title: BOTOX® (Botulinum Toxin Type A) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Masseter Muscle Prominence
Keywords: Masseter Muscle Prominence
BOTOX
Botulinum Toxin Type A
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominice (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP.

BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is 1 in 4 chance that participants will be assigned to placebo. Around 248 adult participants with MMP will be enrolled in the study at approximately 30 sites in Europe.

Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to the masseter on Day 1. Participants who are eligible for retreatment will be given BOTOX on Day 180 and will be followed for up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Body mass index \< 30 kg/m\^2 using the calculation: BMI = weight (kg)/height (m)\^2, rounded to the nearest whole number.
* Participants meets the following criteria:

  * Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right side of the face), as determined at screening and at the Day 1 visit by the investigator using the MMPS.
  * Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined at the Day 1 visit by the participant using the MMPS-P.
  * MMP grades, as assessed by investigator and participant, do not need to be identical but have to be a minimum of Grade 4 with bilateral symmetry at Day 1.
* Participants who responded "A lot" or "Extremely" bothered by the appearance of their MMP as measured by the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) and attain a total score of ≥ 15 on the Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA), determined at the Day 1 visit.

Exclusion Criteria:

* Has current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator.
* Has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator.
* Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading, as determined by the investigator.
* Has 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.
* History of dental or surgical procedure for lower facial shaping or masseter muscle reduction.
* History of any soft tissue fillers in the jawline.
* Has prior exposure to botulinum toxin of any serotype to any part of the body (not including masseter muscle) within the 3 months prior to Day 1.
* History of or current TMJD, or presence of signs/symptoms of possible TMJD in the opinion of the investigator.

Primary outcomes:
measure: Achievement of 2-grade or more improvement from baseline on the Masseter Muscle Prominence Scale (MMPS) as assessed by the Investigator
timeFrame: Day 90
measure: Achievement of 2-grade or more improvement from baseline on the Masseter Muscle Prominence Scale - Participant (MMPS-P) as assessed by the Participant
timeFrame: Day 90
Secondary outcomes:
measure: Response of "Very Satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT)
timeFrame: Day 90 to Day 180
measure: Response of "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP)
timeFrame: Day 90 to Day 180
measure: Change from baseline in lower facial volume (cm^3)
timeFrame: Day 90
measure: Change from baseline in lower facial width (mm)
timeFrame: Day 90
measure: Change from baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) summary score
timeFrame: Day 90 to Day 180
Other outcomes:
Locations:
city: Beerse
country: Belgium
facility: Da Vinci Clinic /ID# 246731
state: Antwerpen
city: Schilde
country: Belgium
facility: Evolve Clinic /ID# 246729
state: Antwerpen
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 246311
state: Bruxelles-Capitale
city: Melle
country: Belgium
facility: Lightfalls Clinic /ID# 247335
state: Oost-Vlaanderen
city: Plovdiv
country: Bulgaria
facility: Dermavist - Group Practice for Specialized Medical Care for Skin Disease /ID# 247630
city: Sofia
country: Bulgaria
facility: Medical Centre Dermatology Dr. Denkova EOOD /ID# 246591
city: Sofiya
country: Bulgaria
facility: Medical Center Derma Vita EOOD /ID# 247327
city: Antibes
country: France
facility: Mediti /Id# 246875
city: Cannes
country: France
facility: Cabinet Dermatologie et Esthetique /ID# 246871
city: Paris
country: France
facility: Cabinet médical /ID# 246873
city: Toulouse
country: France
facility: Cabinet de Chirurgie Plastique et Esthétique /ID# 246872
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics /ID# 246600
state: Bayern
city: Muenchen
country: Germany
facility: Studienzentrum Theatiner46 /ID# 246601
state: Bayern
city: Duesseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner /ID# 246602
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Hautzentrum Koeln /ID# 247502
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Universitaet Hamburg /ID# 247503
city: Latina
country: Italy
facility: Azienda Unita Sanitaria Locale Latina /ID# 246835
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico /ID# 246836
city: Verona
country: Italy
facility: CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 246834
city: Vigo
country: Spain
facility: Gavín Dermatólogos /ID# 252120
state: Pontevedra
city: València
country: Spain
facility: Clinica Alejandria /ID# 247380
state: Valencia
city: Madrid
country: Spain
facility: Grupo Pedro Jaen /ID# 246485
city: Madrid
country: Spain
facility: Clinica Robega /ID# 252239
city: Coatbridge
country: United Kingdom
facility: Waverley Medical Practice /ID# 246432
state: Lanarkshire
city: Edinburgh
country: United Kingdom
facility: Dr Nestor's Medical Cosmetic Centre /ID# 246437
city: London
country: United Kingdom
facility: Interface Aesthetics Training Limited /ID# 248115
city: Sutton Coldfield
country: United Kingdom
facility: MediZen /ID# 246431
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: