A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of HA IDF II Versus Perlane in Nasolabial Fold Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.
研究概览
简要总结
This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.
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
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Women in 30~55 years.
- •Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
- •Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.
排除标准
- •Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
- •Those with a history of severe allergy
- •Those with hypertrophic scar or a history of kelloid
- •Patients with an autoimmune disease
- •Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
- •Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
- •Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
- •Patients with a malignant tumor
- •Women in pregnancy or lactation
- •Hepatitis carriers or VDRL/HIV positive patients
- •Those with a hypersensitivity to the investigational medical device of this study
- •Other persons including those considered as difficult to perform this study by the principal investigator
结局指标
主要结局
Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.
时间窗: Week 26 (Visit 7)
Wrinkle Severity Rating Scale (WSRS) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone
次要结局
未报告次要终点