Open Label Extension Study for 43USSA1705 (A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96
研究概览
简要总结
To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
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
- •Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705
排除标准
- •Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
- •Other condition preventing the subject from entering the study in the Investigator's opinion
- •Participation in any interventional clinical study throughout the duration of the study
结局指标
主要结局
Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96
时间窗: Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints. Lower scores indicate better outcome. Effectiveness is defined as change from baseline on both sides of the face using WAS at 72 and 96 weeks after the first treatment session. Baseline was defined as the observation that was closest to but prior to study treatment at the baseline visit/first treatment in Study 43USSA1705 (NCT03780244). Therefore, Weeks 72 and 96 in timeframe represents timepoints of current extension study and calculated from baseline of 43USSA1705 (NCT03780244).
次要结局
- Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment(At Weeks 72 and 96 (assessed in the current extension study))
- Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment(At Weeks 72 and 96 (assessed in the current extension study))
- FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Would You do the Treatment Again?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?(At Weeks 72 and 96 (assessed in the current extension study))
- Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?(At Weeks 72 and 96 (assessed in the current extension study))
- Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs(From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study))