Effectiveness and Safety of Platelet-rich Plasma and Topical 5% Minoxidil Combination Compared to Topical 5% Minoxidil Monotherapy in Male Androgenetic Alopecia
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Hair Density
研究概览
简要总结
The goal of this clinical trial is to learn about the effectiveness and safety of platelet-rich plasma (PRP) and topical 5% minoxidil combination therapy compared with topical 5% minoxidil monotherapy in male androgenetic alopecia.
The main questions it aims to answer are:
- Is there a difference in average change of hair density between groups that were given a combination of PRP injection and topical minoxidil compared to topical minoxidil as monotherapy?
- Is there a difference in average change of hair thickness between groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?
- Are there any differences in side effects between groups that were given combination of PRP and topical minoxidil compared to topical minoxidil as monotherapy?
详细描述
The trial will be held for three months in Jakarta, Indonesia. Participants are required to undergo hair examinations every 4 weeks, for a total of 4 visits. Researchers will compare groups that were given a combination of PRP and topical minoxidil compared to topical minoxidil alone as a control group. Hair density, hair thickness, and overall side effects of treatment will be measured at each visit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men between 18 and 50 years old
- •Diagnosed with grade III-VI androgenetic alopecia based on Hamilton-Norwood scale
- •Willing to be the research subject and make regular follow-up visits.
排除标准
- •Conditions of baldness other than androgenetic alopecia based on anamnesis and physical examination, namely telogen effluvium, alopecia areata, trichotillomania, syphilis secondary, systemic lupus erythematosus, alopecia due to chemotherapy, autoimmune, or malignancy.
- •Taking oral medications or vitamins that aim to increase the amount of hair in the last 1 month.
- •Using topical medication that aims to increase the amount of hair in the last 2 weeks.
- •Suffering from active bacterial, viral, or fungal infections of the scalp.
- •Underwent cosmetic procedures for androgenetic alopecia treatment (such as PRP injections, laser procedures, or microneedle) within the last 3 months prior to the study.
- •History of keloids.
- •History of blood clotting disorders.
研究组 & 干预措施
Intervention Group
The first group, called the intervention group, will receive a combination therapy of platelet-rich plasma injection (PRP) with topical 5% minoxidil for three months. PRP injection will be given every 4 weeks with a total of three injections. Respondents will be instructed to apply topical minoxidil twice daily for three months.
干预措施: Platelet-Rich Plasma and Topical 5% Minoxidil (Combination Product)
Control Group
The second group (control group) will receive topical 5% minoxidil as standard therapy. Respondents will be instructed to apply topical minoxidil twice daily for three months.
干预措施: Topical 5% Minoxidil (Drug)
结局指标
主要结局
Hair Density
时间窗: Three months
Change in average hair density will be reported in /cm2
Hair Thickness
时间窗: Three months
Change in average hair thickness will be reported in milimeters
次要结局
- Subjective side effects(Three months)
- Objective side effects(Three months)
研究者
Adhika Ayu Lestari
MD
Indonesia University