NCT04595331已完成不适用
Open Label Extension for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 111
- 试验地点
- 15
- 主要终点
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest
研究概览
简要总结
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject completed Month 12 of study 43USSA1812
- •Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
排除标准
- •For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.
结局指标
主要结局
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest
时间窗: At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
次要结局
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment(At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment(At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Make You Look Younger?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Subject Satisfaction: Would You Recommend the Treatment to a Friend?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Subject Satisfaction: Would You do the Treatment Again?(At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores(Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs(From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks))
研究者
研究点 (15)
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