EUCTR2005-005235-96-GB进行中（未招募）1 期
A Double-Blind Comparison of the Safety and Efficacy of Dysport® and BOTOX® (Botulinum Toxin Type A) in the Treatment of Female Subjects with Severe Glabellar Rhytids
Cranley Clinic0 个研究点目标入组 60 人开始时间: 2005年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
入选标准
- •-Female subjects of any race, between 30 and 50 years of age
- •-Glabellar rhytids
- •-Able to understand the requirements of the study and sign Informed Consent and Photography Release forms
- •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
- •-Pregnant, or planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
- •-Planned facial cosmetic procedure during the study period or with prior cosmetic procedures or visible scars
- •-Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids
- •-Have had previous cosmetic surgery to the upper face
- •-Laser resurfacing, dermabrasion, or soft tissue augmentation in the frontal glabellar periocular area in the 12 months preceding Visit 1
- •-Any medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
- •-Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular function
- •-Profound atrophy/excessive weakness of muscles in target areas of injection
- •-History of facial nerve palsy
- •-Infection at the injection site or systemic infection
- •-Allergy or sensitivity to any component of the study medication
- •-Have had previous botulinum toxin therapy of any serotype for any reason within 6 months of the Baseline/Screening Visit
- •-Alcohol or drug abuse is evident
- •-Medical and/or psychiatric problems interfering with the study results
- •-History of poor cooperation, non-compliance with medical treatment, or unreliability
- •-Current participation in an investigational drug study or having participated in an investigational drug study within 30 days of the Baseline Visit
研究者
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