A Pilot Clinical 'Proof of Concept' Study of Activated Platelet-rich Plasma (PRP) in Subjects With Androgenetic Alopecia (AGA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in hair density and hair regrowth
研究概览
简要总结
A clinical trial to assess the effects and safety of PRP activated with pulsed electrical fields (PEFA-PRP) compared with unactivated PRP when used to treat AGA.
The design of this small-scale, phase 1b/2a clinical trial is to demonstrate that pulsed electric field activation of autologous PRP results in a controlled release of platelet growth factors and other biologically active molecules that will have a benefit effect on the non-cycling hair follicles in the treated scalp compared to non-activated PRP. This single-center, auto-controlled study will compare the clinical benefit of PEFA-PRP versus non-activated PRP treatment of male patients with AGA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male between 30 and 60 years of age, inclusive
- •A clinical diagnosis of AGA (stage II to V, according to the Hamilton-Norwood Scale)
- •Non-smokers in good general health, as determined by the Investigator
- •Willing and able to tolerate multiple injections and attend all study visits
- •Willing to maintain the same hair style as at the Screening Visit for the duration of the study
- •Willing to have blood drawn.
排除标准
- •Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
- •Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- •Current significant skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis) that might interfere with the study conduct or evaluations
- •History of surgical correction for hair loss such as transplantation
- •Previous exposure to Platelet-rich Plasma (PRP) for alopecia
- •Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within 30 days prior to the Screening Visit
- •Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 30 days prior to the Screening Visit
- •No history of burning, flaking, itching, and stinging of the scalp
- •History of malignancy (except basal cell and squamous cell skin cancers) or undergoing chemotherapy or radiation treatments
- •A known history of autoimmune thyroid disease, any other thyroid disorder or other autoimmune disorders that in the opinion of the investigator may interfere with the study treatment
- •Significant tendency to develop keloids or hypertrophic scarring
- •A known history of significant physical or mental disease that the Investigator feels may impact the subject's participation
- •The use of aspirin or other NSAIDs (Nonsteroidal anti-inflammatory drugs) such as Nurofen, Voltaren, Diclofenac or Naproxen 7 days before beginning each of the treatments during the study
- •The use of Vitamin E supplements (other than in multivitamins) 14 days before beginning each of the treatments during the study
- •Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents such dabigatran, rivaroxaban, apixaban, edoxaban and betrixaban; warfarin/coumarins
- •Hereditary or acquired hematological/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia)
- •Utilization of low-level lasers to scalp within 90 days prior to the Screening Visit
- •Platelet count of less than 150,000 platelets/µL as measured by automated complete blood cell count and differential at or around the time of treatment (within 3 days of injection)
- •Treatment with another investigational drug or other intervention within the previous 180 days
- •Current smoker or tobacco use within the previous 2 years
研究组 & 干预措施
Autocontrolled Arm
The subject will be treated with both the experimental treatment and the active comparator.
干预措施: Autologous platelet-rich plasma (Biological)
结局指标
主要结局
Change in hair density and hair regrowth
时间窗: Month 6 and Month 8
The change in hair density (hair count and thickness) measured in the region of interest (ROI) at six months and eight months using automated image analysis with Trichovision/Fotofinder imaging software. The change will be compared to the following: 1. Baseline in the same ROI 2. An entire treatment area with diagnosed AGA on the scalp 3. The same region on the contralateral scalp
Measurement of hair regrowth
时间窗: Month 6 and Month 8
The amount of hair regrowth measured in the region of interest (ROI) at six months and eight months using automated image analysis with Trichovision/Fotofinder imaging software. The change will be compared to the following: 1. Baseline in the same ROI 2. An entire treatment area with diagnosed AGA on the scalp 3. The same region on the contralateral scalp
次要结局
- Clinical progression of treatment as determined by principal investigator(Month 6 and Month 8)
- Clinical progression of treatment as determined by subject(Month 6 and Month 8)