The Emotional and Functional Benefits of Poly-L-Lactic Acid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Mean Subject Self Reported Quality of Life Scale
研究概览
简要总结
This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.
详细描述
Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.
- •Subject must have any degree of facial volume loss.
- •Subjects of all Fitzpatrick skin types are eligible.
- •Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
- •Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.
排除标准
- •Any of the previous facial treatments:
- •c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant
- •Have any skin pathology or condition that could interfere with the evaluation of the face.
- •Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
- •Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
- •Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
- •Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- •Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
研究组 & 干预措施
Poly-L-Lactic Acid (Sculptra) injection
Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects
干预措施: Poly-L-Lactic Acid (Sculptra) injection (Drug)
结局指标
主要结局
Mean Subject Self Reported Quality of Life Scale
时间窗: 6 months post initial injection
Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome
Mean Rosenberg Self-Esteem Scale
时间窗: 6 months post initial injection
Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.
次要结局
未报告次要终点