Chang Gung Memorial Hospital, Taipei, Taiwan
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Global Aesthetic Improvement Scale
研究概览
简要总结
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors. According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
详细描述
Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors, such as platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and epithelial growth factor. These growth factors can trigger intracellular signaling cascades that ultimately alter gene expression and protein synthesis. Clinically, autologous platelet-rich plasma has been applied for treatment of hair loss, chronic wounds, and atrophic scars.
Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. The therapeutic modalities of photoaging included energy-based device, filler injection, and surgical treatment. However, there are some limitations and drawbacks of these therapies. For example, filler injection may cause foreign body granuloma, vascular occlusions, or tissue necrosis. Surgical treatment is an invasive procedure which may cause hematoma, infection, or scar formation.
According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. Platelet-rich plasma-enhanced expression of matrix metalloproteinases -1 and -3 helps clear photodamaged extracellular matrix components and allow for a better quality, more organized collagen meshwork. This process helps soften fine lines and minimize scarring. In addition, transforming growth factor and epithelial growth factor in platelet-rich plasma are known to modulate keratinocyte propagation and migration as well as repair barrier function. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
- The participants will blinded to receive platelet rich plasma and platelet poor plasma injections for treatment of photoaging of right side or left side of face.
- The practitioner will inject these blood products into photoaging areas in bilateral face in each case without the knowledge of the content of injection materials.
- The outcomes assessors will evaluate the response of the therapies without the knowledge of which blood products injected into bilateral face.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II)
- •The photoaging severity of bilateral face is symmetric.
排除标准
- •Patients with thrombocytopenia, coagulopathy, hematopoietic malignancy.
- •Patients with severe inflammation over treated area, malignancy, keloid, or poor wound healing history.
- •Patients had received laser, radiofrequency, ultherapy over treated area within 6 months.
- •Patients had received botulism or filler injection over treated area within 12 months.
- •Patients had received plastic surgery over treated area within 12 months.
- •Patients had severe psychiatric disorders with poor control.
- •Patients with other diseases which are not suitable for receiving platelet rich plasma (PRP) injection therapy.
结局指标
主要结局
Global Aesthetic Improvement Scale
时间窗: 3 months after the last session of treatment
To assess the global aesthetic improvement in appearance compared to pretreatment (minimum: -1, worse; maximum: 3, very much improved)
Fitzpatrick wrinkle scale
时间窗: 3 months after the last session of treatment
To assess the severity of wrinkles of photoaging areas (minimum: 1, mild; maximum: 9, severe)
Wrinkle Severity Rating scale
时间窗: 3 months after the last session of treatment
To assess the severity of wrinkles of photoaging areas (minimum: 1, absent; maximum: 5, extreme)
次要结局
- The scores of texture in VISIA system(before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment)
- The scores of pores size in VISIA system(before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment)
- The scores of rhytids in VISIA system(before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment)
- The scores of brownish spots in VISIA system(before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment)
- The scores of pigment spots in VISIA system(before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment)