Effect of Autologous Platelet-rich Plasma on Photoaged Skin: A Prospective Randomized Controlled Trial (Phases A and B)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months
研究概览
简要总结
The goal of this study is to assess the safety, tolerability and effectiveness of platelet rich plasma in the treatment of photoaged skin. This study will be divided into two parts. The first part will assess the safety and tolerability of platelet rich plasma injections as compared to sterile saline injections in subjects' arm with six months follow-up. The second part will assess the effect of platelet rich plasma on the appearance of facial skin in a split face study with platelet rich plasma injections on one side of the face and sterile saline on the other. Outcomes will be recorded for twelve months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of either gender (M/F), 35-60 years old.
- •Subjects are in good health.
- •Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
- •Subjects of either gender (M/F), 35-60 years old.
- •Subjects are in good health.
- •Bilateral cheek wrinkles "in motion" with severities of ≥ type II of Glogau photoaging classification (APPENDIX I).
- •Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
- •Subject requests cosmetic improvement of facial wrinkles.
排除标准
- •Pregnant or lactating.
- •Subjects who are unable to understand the protocol or to give informed consent.
- •Subjects who have a self-reported history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or antiplatelet therapy.
- •Subjects who have active skin disease or skin infection in treatment area. Subjects who have a history of hypertrophic scars and keloids.
- •Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
- •Subject notes that he/she is HIV positive
- •Subjects with history of skin cancer or actinic keratosis
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
- •Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
- •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.
- •Pregnant or lactating.
- •Subjects who are unable to understand the protocol or to give informed consent.
- •Subjects who have a history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or anti-platelet therapy.
- •Subjects who have had topical or oral tretinoin, chemical peeling, botulinum toxin injection or laser and light treatment for facial rhytides or rejuvenation within past 6 months or planning to undergo treatments as described in the next 3 months.
- •Facial surgery in the lower 2/3 of the face or semi-permanent dermal fillers within 1 year prior to study enrollment
- •Subjects who have history of recurrent facial or labial herpes simplex infection.
- •Subjects who have active skin disease or skin infection in treatment area.
- •Subjects who are allergic to lidocaine or prilocaine.
- •Subjects who have a history of hypertrophic scars and keloids.
- •Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
- •Subject notes that he/she is HIV positive
- •Subjects with history of skin cancer or actinic keratosis
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
- •Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
- •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.
研究组 & 干预措施
Platelet Rich Plasma
Concentrated blood platelets from subject will be injected multiple times into the superficial layer of either their arm (Part 1) or one side of their upper face and cheek (Part 2).
干预措施: Harvest PRP Separation System (Device)
Sterile Saline
Sterile saline will be injected multiple times into the superficial layer of either their arm (Part 1) or one side of their upper face and cheek (Part 2)that has not been injected with PRP.
干预措施: Sterile Saline injection (Other)
结局指标
主要结局
Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months
时间窗: Treatment visit, 2 weeks, 3 months and 6 months
Photoaging scores will be recorded for each cheek by two blinded dermatologists at the treatment visit (before treatment)and during the 2 week, 3 month, and 6 month post-treatment visits. Individual scores for each variable (fine lines, mottled pigmentation, roughness, and sallowness) will be recorded by the blinded dermatologists.
Primary Outcome Study Part 1: Safety and Tolerability
时间窗: 2 weeks, 1 month, 3 months and 6 months
The primary outcome measures will be the evaluation of safety and tolerability, which will be assessed by collection of adverse events throughout the feasibility study.
次要结局
- Secondary Outcome Study Part 2: Subject Satisfaction(6 months)
- Secondary Outcome of Study Part 1: Histologic analysis(1 month)
- Secondary Outcome Study Part 2: Self-Assessment(3 and 6 months)
- Secondary Outcome Study Part 2: Rate of Adverse Events(2 weeks, 3 months, 6 months, 12 months)
研究者
Murad Alam
Professor of Dermatology
Northwestern University