A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 10
- 主要终点
- Successful result from the GFX procedure acutely, without adverse effect
研究概览
简要总结
The purpose of this research study is to evaluate the immediate effectiveness of the GFX™ device in reducing the furrows (deep frown lines) between eyebrows (glabellar region).
详细描述
The purpose of this research study is to evaluate the acute ability of GFX to reduce glabellar furrowing.
Patients who have presented to the investigator for correction of glabellar furrows, as classified per the Rated Numeric Kinetic Line Scale Score for Facial Wrinkles Secondary to Hyperkinetic Function (Note: Class 1 or Higher)7 (Appendix N) are candidates for this study. All patients must consent to the procedure and agree to complete their post treatment evaluation visit.
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
- •Has no medical contraindication
- •Presenting 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) are candidates for this study
- •Is at least 18 years of age
- •Signs a written informed consent
- •Understands and accepts the obligation to present for the scheduled follow-up visit
- •Understands that the GFX procedure may not be successful.
排除标准
- •Has had an injection of botulinum toxin to the target area within the previous 3 months and still exhibits a positive cosmetic effect to the glabellar furrow
- •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
- •Is Pregnant
- •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 benefit.
结局指标
主要结局
Successful result from the GFX procedure acutely, without adverse effect
时间窗: 7 to 10 days post procedure
次要结局
- Minimal or transient incidence of minor adverse events(7 to 10 days post procedure)