EUCTR2010-021401-20-DE进行中（未招募）不适用
A Multicenter, Randomised, Double-Blind Study to Evaluate the Efficacy of VISTABEL® (20 units) in the Treatment of Glabellar Lines, When Compared to BOCOUTURE® (30 units)
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
- 220
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. 18 to 65 years old at study entry.
- •2. Moderate to severe glabellar frown lines at maximum frown as assessed by the investigator according to FWS
- •3. Willing and able to complete the entire course of the trial and to comply with trial instructions
- •4. Written Informed Consent
- •5. Negative urine pregancy test for all women of child bearing potential
- •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. Treatment with Vistabel® or Bocouture® would meet any of the contraindications on the Vistabel® or Bocoture® SMPCs, namely:
- •a. Allergy or hypersensitivity to Botulinum Toxin type A or to any excipients of the Vistabel® or Bocoture® formulations.
- •b. Presence of any disease affecting muscular function eg: myasthenia gravis, Eaton Lambert syndrome.
- •c. Presence of infection at the proposed injection site.
- •2. Previous aesthetic treatment with Botulinum toxin within the last 6 months or planned within the study period.
- •3. Any previous treatments with fillers in the glabellar area.
- •4. Any previous insertion of permanent material in the glabellar area
- •5. Any previous surgery within the glabellar region
- •6. Previous treatment with any facial cosmetic procedure in the glabellar area within the last 6 months, or planned within the study period.
- •7. Planned treatment with Botulinuin toxin in any other body region during the study period
- •8. Inability to substantially lessen glabellar frown lines even by physically spreading them apart, or glabellar lines at rest of FWS grade 3
- •9. Marked facial asymmetry or ptosis of eyelid and/or eyebrow
- •10. History of facial nerve palsy
- •11. Bleeding disorders or regular intake of drugs with anticoagulative effect within the last 10 days before Screening
- •12. Concurrent or planned use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function (e.g. D-penicillinamine, curarine-type muscle relaxants, succinylcholine) or that might interfere with the action of Botulinum toxin (e.g. chloroquine)
- •13. Psychiatric problems that, in the investigator's opinion, are severe enough to interfere with trial results
- •14. Females of childbearing potential that are:
- •a. Pregnant
- •c. planning pregnancy during the trial period
- •d. not using appropriate methods of contraception
- •15. Known allergy or sensitivity to the trial medication or its components
- •16. Participation in another clinical trial within 30 days prior to screening
- •17. Any medical or psychiatric problem that, in the opinion of the investigator may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial
研究者
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