A Pilot, Randomized, Single-Blind, Controlled Study Evaluating the Use of Platelet Rich Plasma (PRP) and Microneedling for Facial and Hand Skin Rejuvenation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Wrinkle Severity Rating Scale (WSRS)
研究概览
简要总结
The overall goal of this study is to develop regenerative cell therapy for use in female patients with aging skin. The primary objective of this proposal is to conduct a pilot study on the efficacy and safety of using PRP to treat this condition in females.
详细描述
Recently, there has been interest in treatments which are orientated to more biologically regenerative therapies, with several studies demonstrating successful use for PRP in skin rejuvenation. Although PRP is widely used in clinical dermatology, experimental studies confirming the effects of PRP on aged fibroblasts are very limited.
PRP contains concentrated platelet cells derived from autologous whole blood that are believed to induce the synthesis of collagen and other matrix components by stimulating the activation of fibroblasts, thus rejuvenating the skin when injected into an area of collagen degeneration. In this proposal we will examine whether PRP therapy provides similar or better rejuvenating capacity in women compared to saline solution. The study will be a randomized, controlled trial comparing microneedling with PRP to microneedling with saline solution, in females aged 45 and over with skin aging of face. This study will also compare PRP to saline (given through injections via filler injection technique) in females with aging skin of the hands. Microneedling will not be performed on the hands.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Only female patients are eligible
- •Patients must be 45 years of age or older
- •Patients must have signs of skin aging on face (wrinkles, rough texture, skin atrophy and skin laxity) and hands (loss of fat tissue and visibility of veins and tendons).
- •Patients must have been on stable birth control for the past 6 months if able to conceive
- •Patients are able and willing to provide written informed consent after the study is fully explained
排除标准
- •Patients with clinically abnormal platelet count, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
- •Patients who have had any cosmetic procedures meant to address skin aging of face and hands 3 months prior to enrollment
- •Patients who have had resurfacing laser on face or hands within one year prior to enrollment
- •Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry
- •Patients who are pregnant or currently breast-feeding
- •Patients with systemic, rheumatic, or inflammatory disease or who are immunosuppressed
- •Patients with ongoing infectious disease, including HIV and hepatitis
- •Patients with history of significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
- •Patients participating in a study of an experimental drug or medical device within 30 days of study entry
- •Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer
- •Patients taking anti-aggregating therapy
- •Patients on anticoagulant therapy
- •Patients with history of keloid formation
- •Patients with uncontrolled diabetes
- •Patients with active skin disease or skin infection on the intended treatment areas, at baseline
研究组 & 干预措施
Platelet Rich Plasma, Left face and hands
Subjects will receive PRP on left half of face and saline solution on right half of face through injections via filler injection technique followed by microneedling, and will also receive PRP on dorsal part of left hand and saline solution on dorsal part of right hand through injections via filler injection technique. Microneedling will not be performed on the hands.
Injections will take place every 4 weeks for a total of 3 treatments.
干预措施: Platelet Rich Plasma (Biological)
Platelet Rich Plasma, Right face and hands
Subjects will receive PRP on right half of face and saline solution on left half of face through injections via filler injection technique followed by microneedling, and will also receive PRP on dorsal part of right hand and saline solution on dorsal part of left hand, through injections via filler injection technique. Microneedling will not be performed on the hands.
Injections will take place every 4 weeks for a total of 3 treatments.
干预措施: Platelet Rich Plasma (Biological)
结局指标
主要结局
Wrinkle Severity Rating Scale (WSRS)
时间窗: 24 weeks
The Wrinkle Severity Rating Scale assesses the presence and severity of wrinkles at rest in a rating scale from 0 to 4, where 0 means no visible wrinkles, 1 means minimal wrinkles, 2 means shallow wrinkles, 3 means moderately deep wrinkles and 4 means very deep wrinkles.
次要结局
- Hand Grading Scale(24 weeks)
研究者
Alison J. Bruce
Principal Investigator
Mayo Clinic