NCT03923634已完成不适用
A Prospective Open-label, Multicenter Study Evaluating Princess® RICH in Correction of Fine Lines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)
研究概览
简要总结
Eligible subjects deemed by the treating physician to have sufficient severity to merit treatment of either their lateral canthal lines (LCL) or perioral rhytids (PR) or both will be treated with Princess® RICH at the Baseline visit and at week 3 and 6.
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
- •Subjects deemed by the treating physician to have LCL and/or PR of sufficient baseline severity to merit treatment with Princess® RICH to be corrected
- •A negative urine pregnancy test at Visit 1 and commitment to use an adequate method of birth control for the duration of the clinical investigation (for women of childbearing potential only.)
- •Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation
- •Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation
- •Written signed and dated informed consent
排除标准
- •Tendency to hypertrophic scars, pigment disorders or keloid formation.
- •History of autoimmune disease or receiving therapy for modification of immune response
- •Hypersensitivity to hyaluronic acid or glycerol.
- •Permanent fillers in the areas to be treated.
- •Subjects who are pregnant or breast feeding.
- •Subjects who are anticoagulated or with history of bleeding disorder.
- •Daily treatment with platelet aggregation inhibitors unless previously cleared by their primary care physician.
- •Cutaneous, inflammatory and/or infectious processes present at V0, recurrent herpes simplex or (pre) cancerous lesions in the areas to be treated
- •Known Diabetes mellitus or uncontrolled systemic diseases in the assessment of the investigator.
- •Laser therapy, chemical peeling, dermabrasion or botulin toxin treatment in the area to be treated within less than three months prior to and during the course of the study.
- •Current participation in another clinical investigation
- •Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g, persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)
结局指标
主要结局
Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)
时间窗: Week 8 compared to Baseline
Percentage of responders at week 8 Responder is defined as at least "improved" versus baseline in the fine lines of lateral canthal lines (LCL) and/or perioral rhytids (PR) assessed with the GAIS (Gloabel Aesthetic Improvement Scale) Global aesthetic improvement can be rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse
次要结局
- Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR)(Week 12 and 16 compared to Baseline)
- Ability of Princess® RICH to improve skin hydration(Week 3, 6, 8, 12 and 16 compared to Baseline)
- Ability of Princess® RICH to improve skin tone(Week 3, 6, 8, 12 and 16 compared to Baseline)
- Ability of Princess® RICH to improve skin elasticity(Week 3, 6, 8, 12 and 16 compared to Baseline)
- Subject satisfaction with treatment(Week 8, 12 and 16)
研究者
研究点 (3)
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