NCT00611273已完成4 期
A Multi-center Long Term Efficacy Trial of the GFX For Reduction of Glabellar Furrowing
Advanced Cosmetic Intervention20 个研究点 分布在 2 个国家目标入组 260 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 20
- 主要终点
- Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit.
研究概览
简要总结
Long term efficacy study of GFX for patients undergoing reduction of glabellar furrowing
详细描述
A Multi-center Long Term Efficacy Trial of GFX for the Reduction of Glabellar Furrowing
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient will be included if:
- •Has no medical contraindication
- •Presents for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Class 1 or Higher)
- •Is at least 18 years of age
- •Signs a written informed consent
- •Understands and accepts the obligation to present for scheduled follow-up visits
- •Understands that the GFX procedure may not be successful
- •Presents at the one month follow-up visit with an improvement from the base line RNKLS score
排除标准
- •The patient will be excluded if:
- •Has had an injection of botulinum toxin to the target area within the previous 4 months and still exhibits a positive cosmetic effect to the glabellar frown.
- •Has had silicone, fat, collagen or a synthetic material placed in the glabellar region or surgical correction or excision of the glabellar furrows
- •Has a known bleeding disorder
- •Has received or is anticipated to receive anti-platelets, anti-coagulants, thrombolytics, or cancer therapy
- •Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable)
- •Has a history of chronic or recurrent infection or compromised immune system
- •Has severe allergies manifested by a history of anaphylaxis
- •Has known lidocaine hypersensitivity
- •Is enrolled in another study
- •Has history of keloid formation
- •The investigator believes the patient is not a suitable candidate for the GFX procedure, or is not likely to receive cosmetic benefitPresents at the one month follow-up visit with no improvement from the base line RNKLS score
结局指标
主要结局
Time at which the patient no longer shows an improvement from the base line RNKLS score indicating that the initially successful GFX procedure is no longer effective at a scheduled follow-up visit.
时间窗: 18 months
次要结局
- Minimal or transient incidence of minor unanticipated adverse events.(30 days)
研究者
研究点 (20)
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