EUCTR2008-002713-40-AT进行中（未招募）不适用
A prospective, multicenter, randomized, rater- and subject-blind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botulinum toxin type A in the treatment of glabellar frown line - NT-H2H
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 384
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Female with moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as assessed by the investigator’s rating
- •- Age between 18 and 50 (inclusively)
- •- Willing and able to complete the entire course of the trial and to comply with trial instructions
- •- Written informed consent
- •- For females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at screening and at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner (def. see protocol)
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Severe glabellar frown lines at rest, according to investigator’s rating on FWS
- •- Previous treatment with Botulinum neurotoxin of any serotype in the upper third part of the face within the last 6 months, e.g., treatment of glabellar area, forehead lines, crow’s feet, bunny lines, eyebrow lifting
- •- Previous treatment with biodegradable fillers in the glabellar area within the last 12 months
- •- Previous insertion of permanent material in the glabellar area, including fat graft
- •- Previous treatment with any facial cosmetic procedure photo in the glabellar area within the last 6 months
- •- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these
- •- Any scars in the glabellar are
- •- Any other planned cosmetic procedure in the upper third part of the face during the trial period
- •- Marked facial asymmetry
- •- Ptosis of eyelid and/or eyebrow
- •- Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face
- •- History of facial nerve palsy
- •-Any infection in the area of injection sites
- •- 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
- •- Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal), malignant tumor, or medical history of HIV infection or any findings from laboratory or physical examination performed at screening
- •-Bleeding disorders or intake of drugs in doses that will lead to an anticoagulative effect (e.g. heparin, cumarines, clopidogrel, non-steroidal anti-inflammatory drugs, acetylsalicylic acid) 10 days before injection
- •-Intake of any of the forbidden concomitant medication, e. g. aminoglycoside antibiotics, or other agents that might interfere with neuromuscular function (e.g. D-penicillinamine, curarine-type muscle relaxants, succinylcholine) or might interfere with the action of Botulinum neurotoxin (e.g. chloroquine)
- •- Known allergy or sensitivity to the trial medication or its components
- •- Evidence or suspicion that the subject might not comply with the study directives and/or that he/she is not reliable or trustworth
- •- Evidence or suspicion that the subject is not willing or unable to understand the information that is given to him/her as part of the informed consent, in particular regarding the risks and discomfort to which he/she would agree to be exposed
- •- Evidence of recent alcohol or drug abuse
- •- Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with trial results
- •- Participation in another clinical trial within 30 days prior to screening
- •- Subjects that are imprisoned or are lawfully kept in an institution
- •- Employees or direct relatives of an employee of the CRO, the Study Center or Merz Pharmaceutical
研究者
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