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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
249
Da Vinci Clinic /ID# 246731
Beerse, Antwerpen, Belgium
Evolve Clinic /ID# 246729
Schilde, Antwerpen, Belgium
Universitair Ziekenhuis Brussel /ID# 246311
Jette, Brussels Capital, Belgium
Lightfalls Clinic /ID# 247335
Melle, Oost-Vlaanderen, Belgium
Dermavist - Group Practice for Specialized Medical Care for Skin Disease /ID# 247630
Plovdiv, Bulgaria
Achievement of 2-grade or more improvement from baseline on the Masseter Muscle Prominence Scale (MMPS) as assessed by the Investigator
The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst).
Time frame: Day 90
Achievement of 2-grade or more improvement from baseline on the Masseter Muscle Prominence Scale - Participant (MMPS-P) as assessed by the Participant
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst).
Time frame: Day 90
Response of "Very Satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT)
The LFSQ-TXSAT measures the participant's satisfaction with the effect of treatment on the appearance of their lower face where 2=Very satisfied, 1=Satisfied, 0=Neither satisfied nor dissatisfied, -1=Dissatisfied, -2=Very dissatisfied.
Time frame: Day 90 to Day 180
Response of "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP)
The BIA-MMP is a single item evaluation of how bothered the participant is by the appearance of their lower face where 0=Not at all bothered, 1=A little bothered, 2=Somewhat bothered, 3=A lot bothered, 4=Extremely bothered.
Time frame: Day 90 to Day 180
Change from baseline in lower facial volume (cm^3)
Lower facial volume is calculated from standardized images
Time frame: Day 90
Change from baseline in lower facial width (mm)
Lower facial width is calculated from standardized images
Time frame: Day 90
Change from baseline in Lower Facial Shape Questionnaire - Impact Assessment (LFSQ-IA) summary score
The LFSQ-IA is a 6-item assessment that measures psychosocial impact of the appearance of the lower face where 0= Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Extremely.
Time frame: Day 90 to Day 180
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical Center Derma Vita EOOD /ID# 247327
Sofia, Bulgaria
Medical Centre Dermatology Dr. Denkova EOOD /ID# 246591
Sofia, Bulgaria
Mediti /Id# 246875
Antibes, France
Cabinet Dermatologie et Esthetique /ID# 246871
Cannes, France
Cabinet médical /ID# 246873
Paris, France
...and 17 more locations