Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180
研究概览
简要总结
The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 30 years and 65 years
- •Wrinkle score of at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS)
排除标准
- •For females: pregnancy, lactating, planned pregnancy or unwilling to use contraceptives
- •History of allergic reaction to hyaluronic acid products
- •Facial surgery or implantation of dermal fillers in the nasolabial region within the last 24 months
- •Skin of the nasolabial region affected by cosmetic treatments (e.g. laser therapy within the last 12 months, chemical peeling within the last 3 months, dermabrasion within the last 12 months, botulinum toxin within the last 12 months )
- •Connective tissue diseases
- •Diabetes mellitus or uncontrolled systemic diseases
- •Known human immune deficiency virus-positive individuals
- •Presence of silicone implant or another non-absorbable substance (permanent fillers) in the area of product application
- •Cutaneous lesions in the evaluated area
- •Tendency to keloid formation and/or hypertrophic scars
- •Autoimmune disease
- •History of allergies against cosmetic filling products and re-current herpes simplex
- •History of immune system degradation
研究组 & 干预措施
Princess® VOLUME
Injection of Princess® VOLUME into the deep dermis or subcutis of both nasolabial folds.
A touch-up treatment may be performed at Day 14 if correction is not complete after the first injection.
The injected volumes will be estimated by the investigator and depend on the depth of the nasolabial folds
干预措施: Princess® VOLUME (Device)
结局指标
主要结局
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180
时间窗: From Day 0 to Day 180
The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
次要结局
- Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270(Day 0 to Days 30, 90, and 270)
- Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)(Days 30, 90, 180, and 270)
- Subject Satisfaction(Days 30, 90, 180, and 270)
- Global Aesthetic Improvement Scale (GAIS)(Days 14, 30, 90, 180, 270)