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NCT06399718 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 207
- Enrollment target
NCT06399718 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 207 participants.
The verdict
NCT06399718, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 207 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 a BOTOX injection 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.
Interventions
- DRUG Placebo
- DRUG BOTOX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2025-11-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06399718
The ClinicalTrials.gov registry entry for NCT06399718 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06399718 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06399718 about?
NCT06399718 is a clinical study titled "A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants". 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 NCT06399718?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 207 participants. The study started on 2024-04-30. Estimated completion is 2025-11-10.
What interventions are being tested in trial NCT06399718?
The interventions under investigation include: Placebo (DRUG), BOTOX (DRUG).
Who is sponsoring clinical trial NCT06399718?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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