BOTOX® (Botulinum toxin type A) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study - M23-123

Abbvie Deutschland GmbH & Co. KG0 个研究点目标入组 248 人开始时间: 2022年10月4日最近更新: 2024年8月21日

适应症

试验速览

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•Subject reports that he/she is A lot or Extremely bothered by the appearance of their MMP as measured by the BIA-MMP and attains a total score of >= 15 on the LFSQ-IA, determined at the Day 1 visit., Body mass index = 30 kg/m2 using the calculation: BMI = weight (kg)/height (m)2, rounded to the nearest whole number., • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined at screening and at the Day 1 visit by the investigator using the MMPS. • Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides of the face), as determined at the Day 1 visit by the subject using the MMPS-P. • MMP grades, as assessed by investigator and subject, do not need to be identical but have to be a minimum of Grade 4 with bilateral symmetry at Day 1.

•Subject has current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator., Prior exposure to botulinum toxin of any serotype to any part of the body (not including masseter muscle) within the 3 months prior to Day 1., History of or current TMJD, or presence of signs/symptoms of possible TMJD in the opinion of the investigator., Subject has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator., Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS or MMPS-P grading, as determined by the investigator., Medical condition that may put the subject at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function., History of dental or surgical procedure for lower facial shaping or masseter muscle reduction., No history of any permanent soft tissue fillers in the jawline., No history of any semi-permanent soft tissue fillers, HA fillers, or autologous fat in the jawline within 24 months prior to Day 1.

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