A 12-week , Randomized, Open-label Study of PCC1 in Healthy Volunteers for Skin Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Wrinkle Reduction
研究概览
简要总结
This clinical trial will assess the efficacy of PCC1 for skin rejuvenation. The primary objective is to determine whether these interventions enhance skin barrier function, reduce wrinkles, and improve skin texture and radiance over a 12-week period. The study will involve healthy participants applying the treatments and undergoing assessments at baseline, 6 weeks, and 12 weeks. Secondary objectives include evaluating the safety and tolerability of PCC1, with any adverse effects closely monitored during the trial.
详细描述
As skin ages, intrinsic and extrinsic factors contribute to cellular senescence, disrupting the skin's structure and function. Senescent cells accumulate in the skin, leading to the secretion of senescence-associated secretory phenotype (SASP) factors, which promote inflammation and degrade extracellular matrix proteins like collagen. These changes result in wrinkles, loss of elasticity, and reduced skin barrier function. The study explores anti-senescence strategies using senolytic agents that selectively eliminate senescent cells, aiming to rejuvenate the skin. Compounds like PCC1 and Cellumiva have shown promise in targeting senescent cells by inducing apoptosis and reducing SASP expression, offering a novel approach to skin aging therapy.
This clinical trial is designed to evaluate the efficacy and safety of PCC1 in skin rejuvenation over 12 weeks. Healthy female participants aged 45-65 will be randomly assigned to receive PCC1 or a placebo. The study will measure skin barrier function, wrinkle reduction, and texture/radiance improvements using imaging technologies and participant feedback. Safety will also be monitored through adverse event reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Women aged 45-65
- •any skin type according to the Glogau scale
- •No significant underlying health conditions affecting skin.
- •Willingness to comply with the study protocol.
- •Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments;
排除标准
- •Presence of any dermatological conditions or use of retinoids or similar compounds within 6 months of the study.
- •patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis)
- •patients using other anti-aging treatments within 1 month
结局指标
主要结局
Wrinkle Reduction
时间窗: at baseline, week 6, and week 12.
Quantified using Antera 3D imaging analysis for wrinkle indentation.
Skin Barrier Function
时间窗: at baseline, week 6, and week 12.
Measured via Trans-Epidermal Water Loss (TEWL) using a VapoMeter at baseline, week 6, and week 12.
Skin Texture and Radiance
时间窗: at baseline, week 6, and week 12.
Evaluated via VISIA-CR imaging and expert clinical grading
次要结局
- Self-Perceived Skin Improvements(12 weeks)
- Safety and Tolerability(12 weeks)