NCT03050723已完成不适用
A Prospective, Open-label, Non-comparative, Multicentre, Post-market Clinical Follow-up Study of the Princess® FILLER Performance and Safety for Correction of Facial Lipoatrophy, Morphological Asymmetry of the Face, or Debilitating Scars
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- 6-point scale for clinical response
研究概览
简要总结
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Male or female 18 years of age or older.
- •Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or
- •Morphological asymmetry of the face, or
- •One or more debilitating scars on the face.
- •Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation.
- •Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.
排除标准
- •Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only).
- •History of allergic reaction or hypersensitivity to hyaluronic acid.
- •History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy.
- •Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last 6 months.
- •Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention.
- •Treatment with anticoagulant or antiplatelet drugs
- •Any disease or condition which, in the Investigator's opinion, represents a safety risk for participation in the study
- •Current participation in another clinical trial, or previous treatment with any investigational drug/device within 30 days prior to enrolment
- •Institutionalized persons with legally limited civil rights
研究组 & 干预措施
Princess® FILLER
Other
干预措施: Princess® FILLER (Device)
结局指标
主要结局
6-point scale for clinical response
时间窗: Week 4
The proportion of patients with successful treatment outcome at the Week 4 visit based on the Investigator's opinion, where success is defined as excellent, good, or moderate correction of the defect
次要结局
未报告次要终点
研究者
研究点 (3)
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