A Prospective, Randomized, Multicenter Study Evaluating Saypha® VOLUME Lidocaine* for the Correction of Nasolabial Fold
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- Responder Rate in Reduction of Nasolabial Folds
研究概览
简要总结
Comparison of saypha Volume Lidocaine from 2 different manufacturing locations in correcting moderate to sever nasolabial folds
详细描述
Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be randomized to receive saypha® VOLUME Lidocaine from 1 of 2 manufacturing sites. The device will be injected into the deep dermis or supraperiostal, and subjects will return for follow-up assessments at Week 2, 4, 24, 36, 52 and optional at Week 65, 78 and 104 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) at Week 4, 24, 36, 52 after the treatment and optional at Week 65, 78 and 104 and in comparison to Day 0. Telephone visits will be performed approximately 24 hours post-administration to monitor possible adverse events. In case any adverse events are reported during the telephone visits an unscheduled visit should be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects will be randomized to receive products from one of 2 productions sites. (C1 and HQ, respectively); as the products appear in an identical fashion only the batch numbers will allow identification of the production site; as the allocation of batch numbers to the respective site is not disclosed to the study site team, the entire team will be masked until break of blind
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
- •A subject must meet ALL of the following criteria to be eligible for the study:
- •Male or female 18 years of age or older
- •Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored with 2 or 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
- •subject who meets ANY of the following criteria is NOT eligible for the study:
- •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
- •Any superficial or deep facial surgery or injection or implantation of any dermal fillers (including but not limited to hyaluronic acid, collagen, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, autologous fat injections), application of any absorbable and non-absorbable sutures (thread) for any purpose including wound care and facial lifting, any laser therapy (including but not limited to Neodym-YAG, KTP, IPL, Diode lasers as well as Erbium-YAG, CO2 or other ablative lasers), dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months prior to enrolment, or any chemical peeling procedures (including but not limited to glycolic acid, trichloroacetic acid or phenolic peels) within previous 3 months prior to enrolment, 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 (3 times a year) herpes simplex in the treated area
- •Tendency to hypertrophic scars and/or keloid formation
- •History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
- •Uncontrolled systemic diseases (such as diabetes mellitus)
- •Bariatric surgery within 12 months prior to enrollment or planned during the clinical investigation
- •Use of anticoagulant 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)
- •Any dental procedures one month before until one month after treatment with the investigational device
结局指标
主要结局
Responder Rate in Reduction of Nasolabial Folds
时间窗: 24 Weeks
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24. This anaylsis is done per manufacturing site: C1 and HQ separately and for the overall population. A 'responder' is defined having at least ≥ 1 grade improvement as evaluated with the 5 point-validated NLF-SRS score on both sides of the face. Nasolabial Folds Severity Rating Scale (NLF-SRS) is a validated 5 grade scale where the lower number corresponds to: 0 = None/minimal: No visible/minimal nasolabial folds; 1. = Mild: Shallow but visible nasolabial fold with a slight indentation; 2. = Moderate: Moderately deep nasolabial fold; 3. = Severe: Very deep nasolabial fold with prominent facial feature; 4. = Extreme: Extremely deep and long nasolabial fold with skin redundancy Therefore, the lower the number, the better.
次要结局
- Proportion of Responders at Other Time Points(Week 4, week 36, week 52, week 65, week 78, week 104)
- Change Versus Baseline in Nasolabial Fold Severitry(Week 4, Week 24, Week 36, Week 52 and, optional at Week 65, Week 78 and Week 104)