EUCTR2010-021271-83-DE进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Extension Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects with Facial Rhytides (Crow’s Feet Lines and Glabellar Lines)
适应症
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
- 900
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. Successful completion of Study 191622-099
- •2. Stable medical condition
- •3. Female subjects of childbearing potential must have a negative urine pregnancy test at day 1 prior to study treatment. A woman is considered NOT to be of childbearing potential if she either is postmenopausal with at least 12 consecutive months of amenorrhea or has no uterus.
- •4. Written informed consent has been obtained
- •5. Written Authorization for Use and Release of Health and Research Study Information (US sites only) and Data Protection Consent (European sites only) and/or other documentation in accordance with the relevant country and local privacy requirements has been obtained
- •6. Ability to follow study instructions and likely to complete all required visits
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any condition which precludes a subject’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess CFL severity using the FWS
- •2. Known immunization or hypersensitivity to any botulinum toxin serotype
- •3. Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
- •4. Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
- •5. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
- •6. Females who are pregnant, nursing, or planning a pregnancy
- •7. Females of childbearing potential, not using a reliable means of contraception
- •8. Any uncontrolled systemic disease
- •9. Recent history of alcohol or drug abuse based on the investigator’s judgment
- •10. Anticipated need for surgery or overnight hospitalization during the study
- •11. Subjects who plan for an extended absence away from the immediate area of the study center that would preclude them from returning for all protocol specified study visits
- •12. Subjects who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period
- •13. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study, with the exception of Study 191622-099
- •14. Subject has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
研究者
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