A Prospective Clinical Study to Evaluate Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
研究概览
简要总结
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants willing to comply with the requirements of the study and providing a signed written informed consent
- •Ability to adequately understand the verbal explanations and the written subject information provided in English
- •Subjects seeking augmentation therapy for the lips
- •Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent
排除标准
- •Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- •Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
- •Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
- •Previous facial surgery, within 6 months, below the level of the lower orbital rim
- •Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
- •Participation in any interventional clinical study within 30 days of screening
结局指标
主要结局
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
时间窗: At Week 8
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
时间窗: At Week 48
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
时间窗: 8 weeks after last injection (up to 12 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
时间窗: 24 weeks after last injection (up to 28 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
时间窗: 16 weeks after last injection (up to 20 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
时间窗: 32 weeks after last injection (up to 36 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
时间窗: 40 weeks after last injection (up to 44 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
时间窗: 48 weeks after last injection (up to 52 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
次要结局
- Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)(At Weeks 8, 16, 24, 32, 40, and 48)
- Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48(At Weeks 8, 16, 24, 32, 40, and 48)