NCT03508973已完成不适用
Sculptra for Décolletage Crepiness and Wrinkling
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female volunteer
- •Aged from 40-70 years on the day of screening
- •No known medical conditions that may interfere with study participation
- •Moderate to severe crepiness and wrinkling of the décolletage
- •Willingness to not use any products on their décolleté for the duration of the study
- •Read, understand, and sign informed consent forms
- •Willingness to sign photography release form
- •Willing and able to comply with all follow-up requirements
- •Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage
排除标准
- •Any significant skin disease at treatment area
- •Any medical condition which could interfere with the treatment
- •Inability or unwillingness to follow the treatment schedule
- •Inability or unwillingness to sign the informed consent
- •History of poor wound healing
- •History of keloid formation
- •History of HIV, hepatitis, immuno-compromised
- •Pregnant or lactating
- •Previous use of deep chemical peels on the treatment area
- •Previous injections of Sculptra in the décolletage
- •Known hypersensitivity to Sculptra or any of its ingredients
- •Previous laser or light based treatments to the treatment area 6 months prior to the screening visit
研究组 & 干预措施
Sculptra
Experimental
Sculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage.
干预措施: Sculpta (Other)
结局指标
主要结局
Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale
时间窗: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up
次要结局
未报告次要终点
研究者
David J. Goldberg, MD
David J. Goldberg, MD, JD
Skin Laser & Surgery Specialists
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