A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- NLF-SRS Grade of Nasolabial Folds Change
研究概览
简要总结
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator.
详细描述
This is a prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME Lidocaine, and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) (4, 24 and 36 weeks after the treatment and in comparison to Day 0), global aesthetic improvement (4, 24 and 36 weeks after the treatment). The subject will evaluate pain intensity associated with the treatment (at Day 0 and at Week 2 (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the treatment.
The safety will be evaluated based on occurrence of adverse events, which will be collected throughout the investigation.
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 two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade Nasolabial Folds Severity Rating Scale (NLF-SRS) as assessed by the investigator
- •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
- •Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
- •History of mental disorders or emotional instability
- •History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
- •Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
- •Facial surgery or implantation of dermal fillers, absorbable and nonabsorbable sutures (thread), laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months, or chemical peeling within previous 3 months, or planning to undergo such procedures in the treatment area during the study
- •Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
- •Cutaneous lesions in the treatment area
- •Known human immune deficiency virus-positive individuals
- •History of allergies against aesthetic filling products and recurrent herpes simplex
- •Tendency to hypertrophic scars and/or keloid formation
- •History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
- •Diabetes mellitus or uncontrolled systemic diseases
- •Use of anticoagulant, antiplatelet or thrombolytic medication from 10 days pre- to 3 days post injection
- •Any medical condition which, in the investigator's opinion. prohibits the inclusion in the study
- •Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
- •Previous enrolment in this 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
NLF-SRS Grade of Nasolabial Folds Change
时间窗: 24 weeks
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
NLF-SRS Grade of Nasolabial Folds Reduction
时间窗: 24 weeks
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 24 versus baseline. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
次要结局
- NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints(Week 4, Week 36)
- NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints(week 4, week 36)
- Aesthetic Improvement(week 4, week 24, week 36)
- Subjects' Satisfaction With Aesthetic Outcome(week 4, week 24, week 36)
- Pain Intensity(Day 1, Day 15)
- NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer(Week 24)