A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants

Masseter Muscle Prominence Clinical Trial

Official title:

BOTOX® (Botulinum Toxin Type A) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068855
• Other study ID #: M23-123
• Secondary ID: 2022-500568-37-0
• Status: Recruiting
• Phase: Phase 3
• Start date: October 17, 2023
• Est. completion date: November 25, 2025

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: November 25, 2025
• Est. primary completion date: November 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Masseter Muscle Prominence

Intervention

Drug:
• BOTOX
Intramuscular Injections
• Placebo
Intramuscular Injections

Locations

Country	Name	City	State
Belgium	Da Vinci Clinic /ID# 246731	Beerse	Antwerpen
Belgium	Universitair Ziekenhuis Brussel /ID# 246311	Jette	Bruxelles-Capitale
Belgium	Lightfalls Clinic /ID# 247335	Melle	Oost-Vlaanderen
Belgium	Evolve Clinic /ID# 246729	Schilde	Antwerpen
Bulgaria	Dermavist - Group Practice for Specialized Medical Care for Skin Disease /ID# 247630	Plovdiv
Bulgaria	Medical Centre Dermatology Dr. Denkova EOOD /ID# 246591	Sofia
Bulgaria	Medical Center Derma Vita EOOD /ID# 247327	Sofiya
France	Mediti /Id# 246875	Antibes
France	Cabinet Dermatologie et Esthetique /ID# 246871	Cannes
France	Cabinet médical /ID# 246873	Paris
France	Cabinet de Chirurgie Plastique et Esthétique /ID# 246872	Toulouse
Germany	Privatpraxis Dr. Hilton & Partner /ID# 246602	Duesseldorf	Nordrhein-Westfalen
Germany	Universitaet Hamburg /ID# 247503	Hamburg
Germany	Hautzentrum Koeln /ID# 247502	Koeln	Nordrhein-Westfalen
Germany	Hautok and Hautok-cosmetics /ID# 246600	Muenchen
Germany	Studienzentrum Theatiner46 /ID# 246601	Muenchen	Bayern
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 246836	Rome	Roma
Italy	CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 246834	Verona
Spain	Clinica Robega /ID# 252239	Madrid
Spain	Grupo Pedro Jaen /ID# 246485	Madrid
Spain	Clinica Alejandria /ID# 247380	València	Valencia
Spain	Gavín Dermatólogos /ID# 252120	Vigo	Pontevedra
United Kingdom	Waverley Medical Practice /ID# 246432	Coatbridge	Lanarkshire
United Kingdom	MediZen /ID# 246431	Sutton Coldfield

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Belgium,  Bulgaria,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 90
Primary	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).	Day 90
Secondary	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.	Day 90 to Day 180
Secondary	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.	Day 90 to Day 180
Secondary	Change from baseline in lower facial volume (cm^3)	Lower facial volume is calculated from standardized images	Day 90
Secondary	Change from baseline in lower facial width (mm)	Lower facial width is calculated from standardized images	Day 90
Secondary	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.	Day 90 to Day 180

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