NCT03430986已完成不适用
A Randomized, Multicenter, "No-Treatment" Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine Injectable Gel for the Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 164
- 试验地点
- 5
- 主要终点
- Volume Change From Baseline in the Nose Area
研究概览
简要总结
The purpose of this study is to determine whether VOLUMA with Lidocaine is safe and effective for the improvement of volume and aesthetic appearance of the nose in the Chinese population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is not satisfied with his/her aesthetic appearance due to structural features of his/her nose and assessed as either "dissatisfied" or "very dissatisfied" by using the 5-point Nose Satisfaction Scale (NSS)
- •Requires a total volume of at least 0.5 mL but not exceeding 3.0 mL of VOLUMA with Lidocaine for initial and touch-up treatment combined, and treatment to the nasal dorsum is mandatory to achieve an aesthetic improvement in the subject's nose appearance, in the Treating Investigator (TI's) opinion
- •Has a reasonable treatment goal for aesthetic improvement in nose, in the TI's opinion. Participant and TI have aligned the treatment goals.
排除标准
- •Has a small, shallow nose such that the volume of filler implant needed to create the desired dorsal height is in excess of the ability of the skin and soft tissue to expand and accommodate the implant
- •Has active autoimmune disease
- •Is on a concurrent regimen of lidocaine or structurally-related local anesthetics (eg, bupivacaine)
- •Is on an ongoing regimen of anti-coagulation therapy (eg, warfarin)
- •Within 10 days of undergoing study device injection, is on an ongoing regimen of medications (eg, aspirin or ibuprofen) or other substances (eg, high doses of Vitamin C or Vitamin E or herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time, or is currently menstruating (study treatment may be delayed as necessary to accommodate menstrual period cessation and/or anticoagulation washout interval)
- •Has participated in any clinical trials within 4 weeks prior to signing the informed consent form (ICF) or is planning to participate in another clinical trial during the course of this study
- •Females who are pregnant, nursing, or planning a pregnancy during the course of the study. Females of childbearing potential who have a positive pregnancy test result during screening. Females who intend to breastfeed during the study. Females of childbearing potential who are unwilling to use birth control measures during the full course of the study. Birth control measures include oral contraceptives (stable) use for 2 or more cycles prior to screening), intrauterine devices, hormonal injections, hormonal implants, bilateral tube ligation, vasectomy, condom or diaphragm plus either contraceptive sponge, foam, or jelly
结局指标
主要结局
Volume Change From Baseline in the Nose Area
时间窗: Baseline (Last value prior to treatment for the treatment group and last value prior to randomization for control group) to Week 24
Volume of the nose was calculated by digital analysis of each participant's 3-dimensional (3D) images. A mixed-effects model for repeated measures (MMRM) was used for analysis. A positive change from Baseline indicates improvement. An analysis model was created by Canfield Scientific, only volume changes are available. Actual Baseline values are not available.
次要结局
- Percentage of Participants Where the Evaluating Investigator Noted "Improved" or "Much Improved Using the Global Aesthetic Improvement Scale (GAIS)(Week 24)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) in the Control Period(24 Weeks)
- Percentage of Participants Who Noted "Satisfied" or "Very Satisfied" With Treatment Outcome on the Nose Satisfaction Scale (NSS) in the Treatment Group(Week 24)
- Percentage of Participants Who Noted "Improved" or "Much Improved" as Assessed by the Participant Using the GAIS in the Treatment Group(Week 24)
研究者
研究点 (5)
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