NCT01940575已完成不适用
Clinical Trial to Evaluate the Safety and Efficacy of SkinPlus-Hyal® as Tissue Restorative Biomaterials in the Improvement of Bilateral Nasolabial Fold Wrinkles
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 3
- 主要终点
- The change in WSRS of the test group and control group
研究概览
简要总结
- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial
详细描述
- Subjects:Adults with nasolabial fold
- Investigational Devices:
Study Device: SkinPlus-Hyal® Comparator Device: Restylane®
- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged over 20
- •Subjects who want to correct his/her nasolabial fold and have point 3 or 4 in WSRS of nasolabial fold and visually symmetric
- •Subjects who voluntarily decided the participation of the study and signed the informed consent
- •Subjects who agree contraception
排除标准
- •Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid
- •Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face
- •Subjects who have a skin disorder on the NLF area
- •Subjects who had permanent implants for dermal augmentation at the NLF area
- •Subjects who had a history of keloid formation or hypertrophic scar
- •Subjects who participated in other clinical trial within 3 months from screening date
- •Female subjects of childbearing potential who disagreed with medically acceptable contraception (e.g., condom, oral contraceptives continuing at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial
- •Subjects who is Drug abuser or alcoholism
- •Subjects who had previous treatment with Botox within 6 months from screening date
- •Subjects who had previous treatment for wrinkle with Retin-A within 1 months from screening date
- •Subjects who had previous treatment with tissue restorative biomaterials within 18 months from screening date
- •Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
- •Subjects who had antigen of HIV or type-B Hepatitis
- •Subjects who had anti-coagulant therapy within 2 weeks from the screening date
- •Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
结局指标
主要结局
The change in WSRS of the test group and control group
时间窗: Baseline and 24 weeks
The change in WSRS of the test group and control group from baseline at 24 weeks as assessed by the Investigator in charge of photographic assessment
次要结局
- The change in WSRS of the test and control groups(baseline and 2, 8, 16, 24 weeks)
研究者
研究点 (3)
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