A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Sculptra for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 205
- 试验地点
- 6
- 主要终点
- Percentage of Participants With 1 Point Improvement From Baseline on the Medicis Midface Volume Scale (MMVS) as Measured by the Blinded Evaluator at Month 12
研究概览
简要总结
This is a randomized, evaluator-blinded, no-treatment controlled study in participants with Midface Volume Deficit and/or Midface Contour Deficiency.
详细描述
For Group A, after screening, eligible participants will be treated from day 1 and followed up for 24 months. The purpose of Group A was to confirm investigator's use of correct injection technique.
For Group B, the study includes two phases as follows:
Main study phase: It is randomized, evaluator-blinded and no-treatment controlled. After screening, all eligible participants will be randomized either to the Treatment Group or the Control Group in a 2:1 ratio. All the participants will be followed up for 12 months.
Extension study phase: After the main study phase, the Treatment Group will be followed up for additional 12 months.
Each subject assigned to Group A and Treatment Group will receive up to 4 injection sessions with 5(±1) weeks intervals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent to participate in the study.
- •Men or women aged 18 years of age or older of Chinese origin.
- •Participants seeking augmentation therapy for the midface.
- •MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator.
排除标准
- •Known/previous allergy or hypersensitivity to any of the constituents of the product.
- •Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
- •History of severe or multiple allergies, such as anaphylaxis.
- •Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the area to be treated within 6 months before treatment.
- •Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
- •Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant in the area to be treated.
- •Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. participants not likely to avoid other facial cosmetic treatments, participants anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
结局指标
主要结局
Percentage of Participants With 1 Point Improvement From Baseline on the Medicis Midface Volume Scale (MMVS) as Measured by the Blinded Evaluator at Month 12
时间窗: Baseline, Month 12
MMVS is a 4-grade scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator rated the participant's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. A one grade decrease in score from baseline was defined as a treatment success/improvement, meaning that lower score means a better outcome. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
次要结局
- Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Blinded Evaluator(Treatment group: Baseline, Months 6, 9, 18 and 24; Control group: Baseline, Months 6 and 9)
- Percentage of Participants With 1 Point Improvement From Baseline on the MMVS as Measured by the Treating Investigator(Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12)
- Total Volume Change From Baseline Over Time of the Right and Left Midface Areas(Treatment group: Baseline, Months 6, 9, 12, 18 and 24; Control group: Baseline, Months 6, 9 and 12)
- Percentage of Responders According to the Global Aesthetic Improvement Scale (GAIS) on Both Sides of the Face Combined as Assessed by the Treating Investigator(Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12)
- Percentage of Responders According to the GAIS on Both Sides of the Face Combined as Assessed by the Participant(Treatment group: Months 6, 9, 12, 18 and 24; Control group: Months 6, 9 and 12)
- Percentage of Participants Agreeing That Their Cheek Volume Deficit and/or Contour Deficiency Was Improved by the Treatment(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Agreeing That Overall Result of the Treatment Looks Natural(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Agreeing That the Treatment Met or Surpassed Their Expectations to the Study Treatment(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Agreeing That Treatment Brings More "Youth/Beauty/Harmony/Symmetrical Appearance/Pep/Liveliness/Freshened Look/Self-esteem/Confidence"(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Agreeing That They Feel More Attractive by the Treatment(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Agreeing That They Feel Better by the Treatment(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Agreeing That They Are Satisfied by the Treatment(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Who Received Positive Feedback About Their Look From Family, Friends and Colleagues(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Who Recommended This Treatment to Their Friends(Treatment group: Months 6, 9, 12, 18 and 24)
- Percentage of Participants Who Liked to Receive the Same Treatment Again(Treatment group: Months 6, 9, 12, 18 and 24)