A Multi Center, Non-comparative Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety After Rhytidectomy Using Non-absorbable Mesh(RPM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.
Study hypothesis
- level of significance: alpha=0.05( two-side)
- power of test: (power= 1-beta),power=0.08
- H0: P equals P0
- H1: P unequals P0
- The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)
详细描述
- Benefits
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enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. Risks
-
erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.Duration of study
-
entire duration: approximate 36weeks
-
Follow-up period: 7 weeks
-
Enrollment period: 12 weeks 4. study design
-
2 step operation process
-
First step- insert polypropylene mesh under the skin
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Second step- pull the polypropylene mesh 3 weeks later
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who had soft tissue sagging around nasolabial fold
- •Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)
- •Subjects who voluntary decided to participate in the study and signed the informed consent
排除标准
- •Subjects who have a skin disease on the face
- •Subjects who have severe facial skin disease
- •Subjects who are constantly taking anti-coagulants including aspirin
- •Subjects who have too thin or thick skin
- •Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease
- •Subjects who had an allergy to non-absorbable material.
- •Subjects who are taking immune suppressants
- •General weakness status
- •Pregnant or lactating women
- •Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,
- •Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face
- •Subjects who participated in other clinical trial within 30 days from screening
结局指标
主要结局
The change in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration
时间窗: change in the WSRS from baseline at7 week
The efficacy is assessed by the severity of the fold determined by the WSRS assessed by the investigator with photos WSRS(Wrinkle Severity Rating Scale)is be evaluated from 1 to 5 according to the severity of wrinkles (1= no visible fold, 5= extremely deep and long fold)
次要结局
- The changes in the satisfaction of the pre and post rhytidectomy from baseline at 7week after administration(Changes Satisfaction from baseline at 7week)