NCT04599335已完成不适用
The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS).
研究概览
简要总结
This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30 to 60 years of male or female
- •MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator.
排除标准
- •Injection site with infection or other skin diseases present which may affect the evaluation
- •With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at midface
- •With permanent implants or planning to receive permanent implants during the study period at the injection sites
- •Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 6 months
- •With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period
- •With Major surgery 3 months before the start of the trial
- •With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period
- •With systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.)
- •With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications
- •With epilepsy or porphyria
- •With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency
- •With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period
- •With history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; Gram-positive bacterial or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study
- •Planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change
- •Pregnant, planning pregnancy or in breastfeeding females
- •Participated in clinical study of other device or drug and have not terminated within the past 30 days -Other circumstances which judged to be unsuitable for participating in the study by the investigator
结局指标
主要结局
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS).
时间窗: 6 months
The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator.
次要结局
- On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.(Baseline, 1, 3, 6, 12, 18 and 24 months post-injection)
- Adverse events reported from the baseline and during the study period(Baseline, 1, 3, 6, 12, 18 and 24 months post-injection)
- Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.(Baseline, 1, 3, 6, 12, 18 and 24 months post-injection)
- A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.(Baseline, 1, 3, 6, 12, 18 and 24 months post-injection)
- GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.(Baseline, 1, 3, 6, 12, 18 and 24 months post-injection)
- VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection.(Immediate,15, 30, 45 and 60 minutes post-injection)
- Serious adverse events reported from the baseline and during the study period(Baseline, 1, 3, 6, 12, 18 and 24 months post-injection)
- Device failure reported from the baseline and during the study period(Baseline)
研究者
研究点 (1)
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