EUCTR2008-000549-73-DE进行中（未招募）不适用
A prospective, open-label, international, multicenter trial to investigate the efficacy and safety of NT 201, free of complexing proteins, in the treatment of glabellar frown lines - NT-SPUTNIK
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
- 101
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
- All
入选标准
- •1. Moderate to severe glabellar frown lines at maximum frown as assessed by the investigator according to FWS
- •2. Age: between 18 and 65 years (inclusively)
- •3. Stable medical condition (assessed at Visit 2 and defined in the protocol)
- •4. Willing and able to complete the entire course of the trial and to comply with trial instructions
- •5. Written informed consent
- •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
- •1. Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 months
- •2. Previous treatment with biodegradable fillers in the glabellar area within the last 12 months
- •3. Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
- •4. Previous treatment with any facial cosmetic procedure (e.g. chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
- •5. Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
- •6. Any other planned cosmetic procedure in the upper third part of the face during the trial period
- •7. Inability to substantially lessen glabellar frown lines even by physically spreading them apart
- •8. Marked facial asymmetry or ptosis of eyelid and/or eyebrow
- •9. History of facial nerve palsy
- •10. Any infection in the area of the injection sites
- •11.Any medical condition that may put the subject at increased risk with exposure to NT 201, including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function
- •12. 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
- •13. 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 toxin (e.g. chloroquine)
- •14. Known allergy or sensitivity to the trial medication or its components
- •15. Pregnancy , nursing, or planning of pregnancy during the trial period, or no usage of appropriate methods of contraception (such as implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomised partner) by females of childbearing potential
- •16. Evidence of recent alcohol or drug abuse
- •17. Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with trial results
- •18. Participation in another clinical trial within 30 days prior to screening
研究者
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