Ignite Creation Date:
2024-05-11 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399718
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-01
Brief Title:
A Study to Assess BOTOX Injections for the Change of Masseter Muscle Prominence in Adult Participants
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
BOTOX onabotulinumtoxinA for the Reduction of Masseter Muscle Prominence A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None