NCT00487474已完成不适用
A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of Sculptra (Poly-L-lactic Acid) Measured by Three Dimensional Digital Surface Imaging
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
研究概览
简要总结
- Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging
- Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale
- Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale
- Correlate the mean volumetric change in mid-facial treatment area with the amount of product used
- Evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment
- Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
- Collect safety data
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must sign a statement of informed consent.
- •Subjects must be 18-75 years of age, of any race or gender.
- •Female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study).
- •Subjects must display signs of facial contour deficiencies in the area of the nasolabial folds [nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
- •Subjects must be a suitable candidate for SCULPTRA treatment.
- •Subjects must be able to understand the requirements of the study and be willing to comply with the study requirements
排除标准
- •Subjects with an allergy to any of the constituents of the product.
- •Subjects with a known history of keloids or bleeding disorders.
- •Subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing.
- •Subjects with significant facial hair (e.g. mustaches, beards, etc.)
- •Subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area).
- •Subjects who plan to undergo major facial surgery [e.g., rhinoplasty (with or without implant), facelift, congenital defect repair, etc.] during the course of the study.
- •Subjects who have used or plan to use exclusionary medications/treatments.
结局指标
主要结局
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
时间窗: 6 months
次要结局
- Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale.(6 months)
- Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging(6 months)
- Correlate the mean volumetric change in mid-facial treatment area with the amount of product used.(6 months)
- Determine mean change from baseline in the contour deficiency score as determined by the investigator.(6 months)
- Investigator Global Assessment of Improvement - Excellent Improvement(6 months)
- Investigator Global Assessment of Improvement - Much Improved(6 Months)
- Investigator Global Assessment of Improvement - Improved(6 Months)
- Subject Global Assessment of Improvement - Improved(6 Months)
- Subject Global Assessment of Improvement - No Change(6 Months)
- Subject Global Assessment of Improvement - Worse(6 Months)
- Investigator Global Assessment of Improvement - No Change(6 Months)
- Investigator Global Assessment of Improvement - Worse(6 Months)
- Subject Global Assessment of Improvement - Excellent Improvement(6 Months)
- Subject Global Assessment of Improvement - Much Improved(6 Months)
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