Comparing Platelet-Rich Plasma (PRP) Centrifugation Methods on Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia: A Preliminary, Randomized, Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Thrombocyte Count in PRP and Whole Blood
研究概览
简要总结
This research is a preliminary, randomized, double blind clinical trial, which will examine the differences in PRP preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of Thrombocyte Concentration and Clinical Improvement of Androgenetic Alopecia.
详细描述
Several examinations will be performed in every visit, including history taking, physical examination, trichoscopy and trichoscan. Laboratory evaluations (complete blood count) for the measurement of the thrombocyte for baseline and PRP will be performed for all assented subjects on the first visit. Each subject will be instructed to apply 5% topical minoxidil twice a day everyday as primary therapy during the study
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
this is a double-blind masking study
入排标准
- 年龄范围
- 25 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Met the criteria of androgenic alopecia (Hamilton Norwood grade III-IV)
- •Men between ages 25-59 years old
- •Have stopped taking topical anti-androgen or minoxidil for at least one month, or oral anti-androgen or minoxidil for at least three months
排除标准
- •alopecia of any other type
- •subject with a history of keloid or blood coagulation disorders underwent anticoagulant therapy
- •subjects on Non-Steroidal Anti-Inflammatory Drugs (NSAID) medications in seven days prior to the study
- •subjects who had hair treatment using growth factors, including PRP and microneedling within at least six months prior to the study.
结局指标
主要结局
Thrombocyte Count in PRP and Whole Blood
时间窗: 6 weeks
We assessed the increase in PRP platelet levels by assessing baseline platelets (using whole blood) and assessing platelet levels in PRP preparations and then calculating multiples. platelet valuie units to be used is (/μL)
Clinical Improvement of Androgenetic Alopecia
时间窗: 6 weeks
We assessed the assessment of clinical improvement in androgenetic alopecia using trichoscopy and trichoscan examination on week 0, 2, 4, and 6. On trichoscopic examination we assessed hair color, hair diameter diversity, vellus hair, and dots. Whereas on trichoscan examination we assessed hair count, hair diameter (mm), hair density (/cm2), hair rate (%) in vellus hair, terminal, anagen and telogen phases and assessed hair mean thickness (mm/cm2) and mean length (mm) and average hair per unit.
次要结局
未报告次要终点
研究者
Dr. dr. Lili Legiawati, SpKK(K)
National-board certified dermatologist
Indonesia University