EUCTR2008-001158-42-DE进行中（未招募）不适用
Proof-of-concept study: Prüfung der Wirksamkeit und der Verträglichkeit von Botulinum-Toxin (Xeomin®) bei der Behandlung von Krähenfüßen im Vergleich zu Vistabel® im intraindividuellen Vergleich
Dermatologikum Hamburg0 个研究点开始时间: 2008年4月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Female and male subjects with moderate to severe crow`s feet (severity score of 2 and 3 as assessed by the investigator according to Facial Wrinkle Scale) aged between18 and 65 years
- •Stable medical condition
- •Able to comply with the requirements of this study protocol
- •Written informed consent and data protection statement
- •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
- •Treatment of the upper face with botulinum toxin within 6 month prior to study entry
- •Pretreatment with any permanent filler material in the area to be treated
- •Any cosmetic pretreatment in the area to be treated (e.g. facial injections of dermal fillers, chemical peeling or photo rejuvenation) within 9 month prior to study entry
- •Any additional intended treatment with botulinum toxin in a further localization during the study
- •Any additional intended cosmetic treatment in the area to be treated (e.g. facial injections of dermal fillers, chemical peeling or photo rejuvenation) during the study
- •Any prior surgery or scars in the area to be treated
- •Infections of the injection areas
- •Known adverse reactions of any severity or hypersensitivity to any ingredient of Xeomin® or any medical condition with increased risk by exposure to Xeomin, including Myasthenia gravis, Lambert-Eaton Syndrome, Amyotrophic lateral sclerosis or any other interferences with impairment of neuromuscular functions
- •Known adverse reactions of any severity or hypersensitivity to any ingredient of Vistabel® respectively or any medical condition with increased risk by exposure to botulinum toxin A, including Myasthenia gravis, Lambert-Eaton Syndrome, Amyotrophic lateral sclerosis or any other interferences with impairment of neuromuscular functions
- •Palsy of facial nerves
- •Coagulation disorders or regular administration of drugs with anticoagulative effect within 10 days prior to study
- •Administration of aminoglycosides (antibiotics) or other drugs that may interfere with neuromuscular functions or the efficacy of botulinum toxin
- •Alcohol and drug abuse
- •Pregnant or breastfeeding women and women who are planning to become pregnant or women of childbearing potential that do not use adequate birth control measures during the trial
- •Participation in any other clinical trial within 30 days prior or during this trial
研究者
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