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NCT06387394 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT06387394: Completed Phase 3 study, sponsored by AbbVie.
NCT06387394 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06387394, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study Summary
The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP). BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States. Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up 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 monthly 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.
Primary Outcome
The investigator and participant each assessed the participant's Masseter Muscle Prominence (MMP) using the Masseter Muscle Prominence Scale (MMPS) and the Masseter Muscle Prominence Scale-Participant (MMPS-P), respectively. Both are a 5-point masseter muscle severity scale with grades ranging from 1 (minimal/not at all noticeable) to 5 (very marked/extremely noticeable).
Interventions
- DRUG Placebo
- DRUG BOTOX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2024-04-22 |
| Est. Completion | 2025-11-25 |
| Phase | Phase 3 |
What the finished NCT06387394 record still lists
NCT06387394 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06387394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06387394 about?
NCT06387394 is a clinical study titled "A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence". The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of bo...
What is the current status of trial NCT06387394?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2024-04-22. Estimated completion is 2025-11-25.
What interventions are being tested in trial NCT06387394?
The interventions under investigation include: Placebo (DRUG), BOTOX (DRUG).
Who is sponsoring clinical trial NCT06387394?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06387394's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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