A prospective, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral canthal lines)

Merz Pharmaceuticals GmbH0 个研究点目标入组 368 人开始时间: 2020年4月30日最近更新: 2023年8月21日

适应症

试验速览

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•Outpatients (male or female) 18 years of age or older.
•HFL, GFL, and symmetrical LCL of moderate (score 2) to severe (score 3) intensity at maximum contraction as assessed by the investigator and subject according to the Merz Aesthetics Scales. The rating of the investigator and the subject do not have to coincide as long as they are moderate or severe.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 340
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Previous treatment with botulinum neurotoxin [BoNT] of any serotype in the face within the last 12 months before injection
•Any facial cosmetic procedure within the last 12 months before baseline injection, such as dermal filling, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows.
•Previous treatment with any biodegradable filler in the face within the last 12 months before injection.
•Any previous insertion of permanent material in the face including any insertion of treads in the upper face or at cheeks (regardless of the time between previous treatment and this study).
•Any medical condition that may put the subject at increased risk with exposure to NT 201, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.

发起方