NCT03320824已完成不适用
A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study to Evaluate the Effectiveness and Safety of Restylane Kysse Versus a Control in the Augmentation of Soft Tissue Fullness of the Lip
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 273
- 试验地点
- 14
- 主要终点
- Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS)
研究概览
简要总结
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- •Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
- •Seeking augmentation therapy for the lips
排除标准
- •Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins.
- •Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents.
研究组 & 干预措施
Dermal Filler
Active Comparator
hyaluronic acid
干预措施: Device: FDA Approved Dermal Filler (Device)
New Dermal Filler
Experimental
hyaluronic acid
干预措施: New Dermal Filler (Device)
结局指标
主要结局
Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS)
时间窗: 8 weeks after last injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control).
次要结局
- Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale(16, 24, 32, 40, and 48 weeks)
- Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator)(8, 16, 24, 32, 40, and 48 weeks after last injection)
- Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment(8, 16, 24, 32, 40, and 48 weeks)
- Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q(8, 16, 24, 32, 40, and 48 weeks)
- Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator)(8, 16, 24, 32, 40, and 48 weeks)
- Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator(8, 16, 24, 32, 40, and 48 weeks)
- Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer(8, 24, 40, and 48 weeks)
- Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale(16, 24, 32, 40, and 48 weeks after last injection)
研究者
研究点 (14)
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