A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Galderma R&D
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Protein Expression
研究概览
简要总结
To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
详细描述
This is a randomized, prospective study. This study will enroll approximately 40 subjects across two sites. All subjects have moderate-to-severe cheek wrinkles on both cheeks.
Eligible subjects will first receive punch biopsy on one pre-auricular side according to a pre-determined randomization, followed by a first Sculptra treatment on both cheeks starting at the pre-auricular areas first at Baseline visit. Subjects will receive second Sculptra treatment at Week 4, and an optional third treatment at Week 8. At 12 weeks since last Sculptra treatment, half of the subjects will receive a second punch biopsy on the other pre-auricular side (per randomization). Subjects will have a follow up visit at 24 weeks since last Sculptra treatment. At 36 weeks since last Sculptra treatment, the remaining half will receive a second punch biopsy on the other pre-auricular side (per randomization).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
- •Subject with intent to undergo correction of cheek augmentation or contour deficiencies
- •Subjects willing to have a 3-mm punch biopsy on each preauricular side
- •Subjects willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg/m2) throughout the study
- •Ability of giving consent for participation in the study.
- •Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
排除标准
- •Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
- •Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
- •Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
- •Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
- •Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.
结局指标
主要结局
Protein Expression
时间窗: 12 weeks, 24 weeks, and 36 weeks after Baseline
Punch biopsies will be performed at the pre-auricular areas. Histology staining or immunohistochemistry will be performed on punch biopsy samples to evaluate targeted biomarkers compared to Baseline.
次要结局
- Subject satisfaction using self-assessment questionnaire(12 weeks, 24 weeks, and 36 weeks since final Sculptra treatment)