A Monocentric, Double-blind, Randomized, Active- and Placebo-controlled Split-scalp Study to Evaluate the Clinical Effectiveness of Platelet-rich Plasma (PRP) in the Treatment of Androgenetic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Regen Lab SA
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Evaluate the changes in hair density of androgenetic alopecia
研究概览
简要总结
Platelet rich plasma (PRP) therapy is a novel therapeutic modality that has seen broad applications for a number of medical indications including those in orthopedics, dentistry, and dermatology. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss, but to the best of our knowledge, there has been only one published case series documenting its use for this indication.
详细描述
This study was designed to better assess the efficacy of PRP in hair loss, we therefore propose to study interval intralesional PRP injections for patients with androgenetic alopecia (AGA). Androgenetic alopecia is the most common form of hair loss world-wide. Although there are currently numerous treatment options for this indication including minoxidil, 5-alpha reductase inhibitors and follicular unit transplant, many of the medical treatment options have undesirable side effects, particularly in women of child bearing age. These well-documented adverse reactions include impotency, hypertrichosis, and birth defects.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 18-60 with AGA
- •Completed informed consent form
- •Ludwig stage 1-2 for women
- •Norwood Hamilton Stage 3 to 5 for men
排除标准
- •Pregnancy or breastfeeding
- •Younger than 18 years
- •Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study
- •History of hair transplantation
- •Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening
- •Facial cancer (squamous and basal cell carcinoma, melanoma)
- •Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia).
- •Hemodynamic instability
- •Acute infection
- •Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata)
- •Malignancy with or without metastatic disease
- •Chemotherapy
- •Dermatological diseases affecting the face (e.g. porphyria)
- •Anticoagulant therapy
- •Patients taking Aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen can participate, provided medication is interrupted 7 days before beginning of the treatment
- •Patients taking vitamin E supplements can participate, provided medication is interrupted 14 days before beginning of the treatment
结局指标
主要结局
Evaluate the changes in hair density of androgenetic alopecia
时间窗: 5 months
Evaluate split scalp changes in hair density of androgenetic alopecia after 5 month treatment of Autologous Platelet Rich Plasma prepared with the RegenBCT-1 kit compared to other half of the scalp treated with saline solution.
次要结局
- Evaluate the changes of hair diameter and hair shedding in androgenetic alopecia(5 months)