An Open-Labelled, Multi-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of YTO-459 in Subjects with Ageing Signs.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. To measure the change in the skin after the study treatment using photometric analysis at the end of the study visit compared to the baseline visit between the treatment groups
研究概览
简要总结
Introduction and Background
Ageing of the skin is a multifactorial biological process influenced by both intrinsic (natural ageing) and extrinsic (environmental) factors, especially prolonged exposure to ultraviolet radiation. This leads to structural and functional deterioration of skin components, including collagen and elastin. Collagen accounts for 70–80% of the skin’s dry weight and is responsible for mechanical strength, while elastin, though comprising only 2–4% of the dermal matrix, plays a vital role in skin elasticity.
Photoaging, caused by UV exposure, results in the breakdown and disorganization of elastin fibers, leading to a condition known as solar elastosis—characterized by dense, dysfunctional elastotic material in the dermis.
Recent advancements have highlighted the regenerative potential of adipose tissue, particularly through fat grafting and the use of mesenchymal stem cells (MSCs) found in the stromal vascular fraction (SVF). MSCs are multipotent cells capable of self-renewal and differentiation, and are now being explored for skin rejuvenation.
Platelet-rich plasma (PRP) has also gained attention for its ability to promote tissue regeneration through growth factors and cytokines. PRP has been used in a wide range of dermatological and cosmetic treatments, including for wrinkles, scars, and wound healing.
Building upon these regenerative approaches, a preclinical study demonstrated that plasma-derived exosomes—specifically E5, a proprietary horse blood plasma-derived exosome—may significantly improve cellular rejuvenation and metabolic function in animal models.
Purpose of the Study
The present clinical study aims to evaluate the safety and efficacy of YTO-459, a novel formulation containing horse plasma-derived exosomes, in individuals with visible signs of skin ageing such as fine lines and wrinkles. This study seeks to establish whether the regenerative properties observed in preclinical models translate into clinical benefits in human subjects, potentially offering a new non-invasive solution for age-related skin concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 55.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of both sexes aged 55 years and above
- •Subjects with fine lines or wrinkles graded as Grade 1 or higher on the Allergan Fine Lines Scale
- •Subjects with mild to moderate crow’s feet wrinkles graded as 3 or above on the Modified Anti-Ageing Atlas 6-point scale
- •Subjects willing to participate in the study by providing signed informed consent.
排除标准
- •Refusal or inability to give informed consent to participate in the study
- •Subjects who have undergone any dermatological or surgical procedure of the hand
- •Subjects who are currently using or have used anti-aging anti-wrinkle Alpha hydroxy acids or retinol-based cosmetics in the past 3 months
- •Participation in or administration of any clinical trials or investigational drugs within 30 days prior to the screening visit
- •History of known bleeding disorders
- •Any relevant or clinically significant condition that may interfere with efficacy or safety assessments during the study drug administration
- •History of drug or alcohol abuse or addiction within the past 5 years
- •Persons under guardianship or those incapable of judgment.
结局指标
主要结局
1. To measure the change in the skin after the study treatment using photometric analysis at the end of the study visit compared to the baseline visit between the treatment groups
时间窗: Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 10, Day 11, Day 12, Day 15 and Day 23
2. To measure the change in class of wrinkle after the study treatment according to MFW Scale at the end of the study visit compared to the baseline visit between the treatment groups
时间窗: Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 9, Day 10, Day 11, Day 12, Day 15 and Day 23
次要结局
- 1. To measure the reduction of fine lines in the skin after the study treatment using Allergan Fine Lines Scale at the end of the study visit compared to the baseline visit between the treatment groups(2. To measure subject satisfaction after the study treatment using the subject satisfaction questionnaire at the end of the study visit compared to the baseline visit between the treatment groups)