A Pilot Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Mild to Moderate Eyebrow Hypotrichosis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Clinical change of eyebrow hypotrichosis, 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 mild to moderate eyebrow hypotrichosis.
This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with mild to moderate eyebrow hypotrichosis. Approximately 40 subjects will be randomized to receive platelet-rich plasma (PRP) or saline injections. The study is designed as an 9-month study. 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 18-85 years old.
- •Subjects are in good health as judged by the investigator.
- •Patients with mild to moderate eyebrow hypotrichosis (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).
- •Those who have less eyebrows and therefore, desire to enhance eyebrows (modified GEyA grades of 3 and 4 at the time of screening, see Appendix A).
- •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
- •Patients with uncontrolled systemic disease (including alopecia areata or any other form of alopecia) which could inhibit hair growth
- •Patients with thrombocytopenia, platelet dysfunction, hypofibrinogenemia, anemia, cancer, active infections with Pseudomonas, Klebsiella, or Enterococcus, history of trichotillomania, thyroid diseases, eye diseases, atopic dermatitis, seborrheic dermatitis, lupus erythematosus, scleroderma, leprosy, or syphilis.
- •Patients who have started used agents that may affect eyebrow hair growth (e.g. minoxidil or bimatoprost) within 6 months of screening. Patients who have been using agents that may affect eyebrow hair growth for at least 12 months may be included if the patient agrees to continue their current dosing regimen for the duration of the study.
- •Known disease, infection, or abnormality in the treatment area or hair shaft
- •Patients with tattoos, scars, hyperpigmentation, or other features which could prevent accurate evaluation of hair growth in the eyebrow area.
- •Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
- •Unwilling to refrain from washing face or using face care products 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.
- •Subject is known to be HIV positive.
- •Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
- •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 (including non-English speaking patients).
研究组 & 干预措施
Platelet-Rich Plasma
Participants will receive intradermal injections of 2-3mL autologous PRP to eyebrows.Three treatments will be performed 1 month apart.
干预措施: Platelet Rich Plasma Prep System (Device)
Placebo (sterile saline)
Participants will receive intradermal injections of 2-3mL sterile saline to eyebrows.Three treatments will be performed 1 month apart.
干预措施: Saline (Drug)
结局指标
主要结局
Clinical change of eyebrow hypotrichosis, 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
Professor of Dermatology
Northwestern University