A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Masseter Muscle Prominence

Treatments: Drug: BOTOX; Drug: Placebo for BOTOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06137287

M22-080

Details and patient eligibility

About

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 prominence (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 4 groups, called treatment arms. Each group receives a different treatment. There is 1 in 5 chance that participants will be assigned to placebo. Around 250 adult participants with MMP will be enrolled in the study at approximately 20 sites in Japan.

Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to each masseter muscle on Day 1. Participants who are eligible for retreatment will be given BOTOX on either Day 180, 210, 240, or 270 and will be followed until approximately Day 360.

There may be a 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, facial photography, checking for side effects and completing questionnaires.

Enrollment: 259 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Japanese individuals.
• Participant with marked or very marked masseter muscle prominence (MMP).

Exclusion criteria

• Asymmetry of left and right sides of the face that could prevent identical Masseter Muscle Prominence Scale (MMPS) or MMPS-P grading on both sides of the face, as determined by the investigator.
• History of permanent soft tissue fillers in the jawline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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259 participants in 4 patient groups

Group 1

Experimental group

Description:

In Period 1, participant will receive 6 injections of BOTOX VISTA Dose A on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270.

Treatment:

Drug: BOTOX

Group 2

Experimental group

Description:

In Period 1, participant will receive 6 injections of BOTOX VISTA Dose B on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270.

Treatment:

Drug: BOTOX

Group 3

Experimental group

Description:

In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose A on either Day 180, 210, 240, or 270.

Treatment:

Drug: Placebo for BOTOX

Drug: BOTOX

Group 4

Experimental group

Description:

In Period 1, participant will receive 6 injections of BOTOX VISTA placebo on Day 1. In Period 2, participants who meet the retreatment criteria will receive 6 injections of BOTOX VISTA Dose B on either Day 180, 210, 240, or 270.

Treatment:

Drug: Placebo for BOTOX

Drug: BOTOX