NCT03780244已完成不适用
A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
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
- 80
- 试验地点
- 6
- 主要终点
- Change in Wrinkle Assessment Scale (WAS) Score
研究概览
简要总结
This study has been designed to evaluate the 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
- 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
- •Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.
排除标准
- •Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
- •Collagen, Hyaluronic Acid- 12 months
- •Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited
- •Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
结局指标
主要结局
Change in Wrinkle Assessment Scale (WAS) Score
时间窗: 48 weeks
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 and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.
次要结局
- Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You do the Treatment Again?(Week 16, 24, 32, 40 and 48)
- Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting(time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12)
- Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment(Weeks 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?(Week 16, 24, 32, 40 and 48)
- Change in Wrinkle Assessment Scale (WAS) Score(Weeks 16, 24, 32, and 40)
- Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment(Weeks 16, 24, 32, 40, and 48.)
- FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire(Baseline and at weeks 24, 32, 40 and 48)
- Satisfaction With Treatment: Does the Treatment Make You Look Younger?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?(Week 16, 24, 32, 40 and 48)
研究者
研究点 (6)
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