A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change of lightness value
研究概览
简要总结
Juvelook® (VAIM, Korea) is made by dissolving irregular PDLLA particles in a solvent mixture of DMSO (Dimethylsulfoxide) and EC (Ethylene Carbonate) and then injecting them through microneedling to create reticulated foamy microspheres, which are hollow spherical particles. It received CE approval in Europe in 2020 and is widely used domestically as a material for tissue restoration, including skin fillers and collagen stimulators. The spherical shape with internal foam structure of PDLLA exhibits excellent biocompatibility, biodegradability, porosity, and mechanical strength. It allows for the control of particle size and acts as a collagen stimulator while gradually dissolving over time. This stimulates fibroblast cells and promotes skin rejuvenation. In clinical practice, Juvelook® particles are injected to address various concerns such as facial wrinkles, increased elasticity, depressed scars, acne scars, accident scars, under-eye hollows, freckles, whitening effects, and neck wrinkles. Therefore, this study aims to investigate the efficacy of Juvelook® not only in volume augmentation but also in improving photoaged skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult women over 30 years old with photoaged skin.
- •Individuals who have a clear understanding of the purpose and content of the study, as well as the potential risks and side effects, and voluntarily sign the informed consent form to participate in the clinical trial.
- •Individuals who are physically healthy and can be tracked and observed throughout the entire study period.
排除标准
- •Individuals who have received anti-aging/whitening treatments (such as laser or chemical peels) on their face within 3 months prior to the start of the study.
- •Individuals who have applied anti-aging/whitening agents to their face within 3 months prior to the start of the study.
- •Pregnant or breastfeeding women.
- •Individuals who are participating in other clinical trials.
- •Individuals who, in the judgment of the researchers, are deemed ineligible to participate in the study.
研究组 & 干预措施
experimental
administer PDLLA
干预措施: PDLLA (Drug)
active comparator
administer saline
干预措施: PDLLA (Drug)
结局指标
主要结局
change of lightness value
时间窗: Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.
change of lightness value by a chromometer
次要结局
- investigator global assessment score for pigmentation(Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.)
- Fitzpatrick wrinkle and elastosis scale(Photos will be taken before each treatment and 4,8,12 weeks after the final treatment)
- patinent global assessment for skin condition(Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.)
研究者
Jin Cheol Kim
Principal investigator, research assistant professor
Ajou University School of Medicine