A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Clinical change of androgenetic alopecia, as determined by scoring photographs
研究概览
简要总结
The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia.
This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized into the study. The study is designed as an 18-month study consisting of 2 phases. This study was a pilot study designed to determine feasibility of this procedure.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 18 years old and ≤55 years old
- •Subjects are in good health as judged by the investigator.
- •Diagnosed with by a dermatologist with moderate androgenetic alopecia.
- •Subject is seeking treatment for androgenetic alopecia.
- •Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
- •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.
排除标准
- •Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
- •Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
- •Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
- •History of a clinically significant hematologic disorder as determined by the investigator.
- •Subjects currently receiving anticoagulant or anti-platelet therapy.
- •Subjects on daily Aspirin therapy for cardiovascular disease.
- •Subjects with chronic NSAID use, unable to wean off.
- •Subject is known to be HIV positive.
- •History of recurrent facial or labial herpes simplex infection
- •History of hypertrophic scars or keloids
- •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
- •Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
- •Pregnant or breast feeding
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Subjects who are unable to understand the protocol or give informed consent.
研究组 & 干预措施
Platelet Rich Plasma
Participants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart
干预措施: Platelet Rich Plasma Prep System (Device)
Placebo (sterile saline)
Participants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart
干预措施: Platelet Rich Plasma Prep System (Device)
Placebo (sterile saline)
Participants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical change of androgenetic alopecia, as determined by scoring photographs
时间窗: Baseline to 6 months
次要结局
未报告次要终点
研究者
Murad Alam
MD
Northwestern University