NCT04124692已完成不适用
A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter 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
- 149
- 试验地点
- 14
- 主要终点
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12
研究概览
简要总结
The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles 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
- 21 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 cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.
排除标准
- •Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
- •Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:
- •Collagen, Hyaluronic Acid - 12 months
- •Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited
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 at Month 12
时间窗: At Month 12
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: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
次要结局
- Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?(At Months 7, 9, and 12)
- Subject Satisfaction: Would You do the Treatment Again?(At Month 12)
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9(At Months 7 and 9)
- Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?(At Months 7, 9, and 12)
- Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?(At Months 7, 9, and 12)
- Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?(At Months 7, 9, and 12)
- Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12(At Months 7, 9, and 12)
- Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Make You Look Younger?(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?(At Months 7, 9, and 12)
- Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment(At Month 12)
- Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?(At Months 7, 9, and 12)
- Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?(At Months 7, 9, and 12)
- Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?(At Months 7, 9, and 12)
- Subject Satisfaction: Would You Recommend the Treatment to a Friend?(At Month 12)
- Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores(Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12)
- 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 12))
研究者
研究点 (14)
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