NCT07399028招募中不适用
A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Galderma R&D
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging
研究概览
简要总结
Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult subjects aged 45-65 years old
- •Females only
- •Subject with moderate-to-severe cheek wrinkles on the GCWS
- •Subject with intent to undergo correction of cheek wrinkles on both sides of the face
- •Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes
- •Subject willing to be photographed at each visit.
- •Subjects willing to stop using current facial skincare products for the duration of the study.
- •Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.
- •Ability to read, understand and give consent for participation in the study.
- •Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.
排除标准
- •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.
研究组 & 干预措施
Treatment Group
Experimental
Subjects will be treated for correction of fine lines and wrinkles in the cheek area with Sculptra. Subjects will receive 3 treatments with Sculptra, four weeks apart.
干预措施: Sculptra® (Device)
结局指标
主要结局
Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging
时间窗: 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline
Images taken with VISIA imaging system and an imaging system using tomography technology at baseline and post-baseline timepoints will be compared to assess structural changes in cheeks.
次要结局
未报告次要终点
研究者
研究点 (1)
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