NCT01305187已完成4 期
Monocentric, Randomized, Subject and Rater Blinded Clinical Investigation to Prove the Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3 Containing Lidocaine - After Single Injection for Correction of Nasolabial Folds (NLF)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The proportion of subjects reporting an equal or better outcome for the side of face treated with Belotero® Basic compared to the side of face treated with Juvéderm® Ultra 3 at V4 on the validated Wrinkle Severity Rating Scale II
研究概览
简要总结
This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with bilateral, symmetrical NLF and wish for correction. Documented severity of NLF score 2 or 3 at screening on the Merz Wrinkle Severity Rating Scale II
排除标准
- •Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal). Subject suffering from diabetes mellitus, autoimmune and rheumatic diseases, clinically relevant coagulation disorders, recurrent angina, or severe psychic, neurological or mental disease
- •History of malignancy within the last 5 years before the study
- •Infection, inflammations or active dermatological disease in the face
结局指标
主要结局
The proportion of subjects reporting an equal or better outcome for the side of face treated with Belotero® Basic compared to the side of face treated with Juvéderm® Ultra 3 at V4 on the validated Wrinkle Severity Rating Scale II
时间窗: Week 4
次要结局
- Overall absolute score change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater(2 Weeks)
- Proportion of subjects feeling the implant at V2 post implantation(Week 0)
- Proportion of subjects feeling the implant at V3.(2 Weeks)
- Proportion of subjects feeling the implant at V4(4 Weeks)
- Overall absolute score change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater(4 Weeks)
- Proportion of overall responders i.e. at least 1 point improvement in the validated Wrinkle Severity Rating Scale II(WSRS II) at V4, based on the intra-individual change in WSRS II compared to baseline before implantation, V2 pre implantation(4 Weeks)
- Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4(4 Weeks)
- Subject Satisfaction Questionnaire results at V4(4 Weeks)
- Global assessment of subject comfort at V4 by the investigator and the subject(4 Weeks)
- Subject Satisfaction Questionnaire results at V3(2 Weeks)
- Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation(Week 0)
- Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation(4 Weeks)
- Overall absolute score change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater(Week 0)
- Global assessment of subject comfort at V3 by the investigator and the subject(2 Weeks)
- Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4(4 Weeks)
- Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation(2 Weeks)
- Overall GAIS by photo rating of an individual rater V2 post implantation and V4(4 Weeks)
- Subject Satisfaction Questionnaire results at V2 pre and post implantation(Week 0)
- Global assessment of subject comfort at V2 post implantation by the investigator and the subject.(Week 0)
研究者
研究点 (2)
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