M23-123: Botox for Reduction of Masseter Muscle Prominence
Research type
Research Study
Full title
BOTOX (Botulinum Toxin Type A) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
IRAS ID
1006348
Contact name
Alice Butler
Contact email
Sponsor organisation
Abbvie Deutschland GmbH Co. KG
Eudract number
2022-500568-37
Research 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 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 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.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0750
Date of REC Opinion
29 Nov 2022
REC opinion
Further Information Favourable Opinion