The Effect of Platelet Rich Plasma on Non-scarring Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Hair Caliber Using Trichoscopy
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or injections of normal saline (placebo). Patients in the treatment group (Group A) will have a small amount of their own blood drawn and have their PRP injected into their scalp four times. The injections will be given at weeks zero, four, eight, and twenty four. The placebo group (Group B) will be given the same schedule but will receive sham injections only and will not have any blood drawn. Both groups will have clinical data collected at all visits, including a screening visit before enrollment and a final assessment visit at week 40, for a total of 6 study visits per patient. Data collection will include representative photographs of the scalp and measurements of hair thickness. The results from the two groups will then be compared.
In summary, all study participants will have a screening visit before enrollment, four study visits for sub-dermal scalp injections, and one final assessment visit at week 40.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must understand and voluntarily sign an informed consent form
- •Must be female between the ages of 18 and 65 years at the time of consent
- •Must be able to adhere to the study visit schedule and other protocol requirements
- •Documented platelet count above 150,000 platelets per microliter within 6 months prior to enrollment
排除标准
- •Previous or current use in the last 1 year of finasteride, minoxidil topical or oral, or spironolactone
- •A diagnosis of non-androgenic alopecia (i.e: another diagnosis for the alopecia )
- •No Baseline ferritin, thyroid-stimulating hormone, platelet count, and a negative urine pregnancy test in any pre-menopausal female in past 12 months.
- •Active skin disease (Psoriasis or severe seborrheic dermatitis) of the scalp
- •Scalp infection
- •Severe active blood infection
- •Cuts or abrasions on the scalp
- •History of surgical hair restoration
- •Current or recent malignancy
- •History of systemic chemotherapy or radiation
- •History of thyroid dysfunction
- •History of autoimmune disorder (specifically Graves disease, hashimoto thyroiditis, or systemic lupus erythematosus)
- •Tendency to develop keloids
- •Nonsteroidal anti-inflammatory or Vitamin E discontinued in the last 7-14 days
- •Platelet dysfunction syndrome
- •Thrombocytopenia less than 150,000
- •Diagnosis of hypofibrinogenemia
- •Anticipated pregnancy or trying to become pregnant in the next 2 years
研究组 & 干预措施
Control
15 participants will receive 3 mL of preservative free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
干预措施: Normal saline (Drug)
Treatment
15 participants will receive 3-6 mL of platelet rich plasma injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24.
干预措施: Platelet Rich Plasma (Device)
结局指标
主要结局
Change in Hair Caliber Using Trichoscopy
时间窗: Week 8 and 24
Change in Hair Caliber using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair caliber in millimeters.
Number of Participants With Improvement
时间窗: through study completion, 24 weeks
Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II
Change in Hair Density Using Trichoscopy
时间窗: Week 8 and 24
Change in Hair Density using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair density (number of hairs in a square centimeter of scalp).
次要结局
- Qualitative Assessment of Hair Growth(Week 40)
- Qualitative Assessment of Pain Associated With the Treatment(Week 40)
- Qualitative Assessment of Adverse Effects Associated With the Treatment(Week 40)
研究者
Hooman Khorasani
Clinical Professor
Icahn School of Medicine at Mount Sinai