Comparative Effectiveness of Secretome Injection and Intradermal Platelet-Rich Plasma Injection on Hair Density and Terminal-to-Vellus Hair Ratio in Patients With Androgenetic Alopecia at Prof. Dr. I.G.N.G. Ngoerah General Hospital
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Terminal-to-Vellus Hair Ratio
研究概览
简要总结
This study aims to compare the effectiveness of secretome injection and intradermal platelet-rich plasma (PRP) injection on hair density and the terminal-to-vellus hair ratio in patients with androgenetic alopecia at Prof. Dr. I.G.N.G. Ngoerah General Hospital.
详细描述
This research is an experimental study with a randomized controlled clinical design involving two intervention groups: one receiving secretome injections and the other receiving intradermal platelet-rich plasma injections. Evaluations are conducted by measuring hair density and the terminal-to-vellus hair ratio before and after treatment using trichoscopy/dermoscopy.
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, Investigator)
入排标准
- 年龄范围
- 25 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male patients with androgenetic alopecia, aged 25 to 59 years, with clinical presentation consistent with Hamilton-Norwood grades II to VI, seeking treatment at the Dermatology and Venereology Outpatient Clinic of Prof. Dr. I.G.N.G. Ngoerah General Hospital.
- •Female patients with androgenetic alopecia, aged 25 to 59 years, with clinical presentation consistent with Ludwig grades I to III, seeking treatment at the Dermatology and Venereology Outpatient Clinic of Prof. Dr. I.G.N.G. Ngoerah General Hospital.
- •Female patients who are not currently pregnant or breastfeeding.
- •Patients who have discontinued anti-androgen medication and minoxidil for at least 1 month prior to the procedure.
- •Patients with no known allergies to secretome components and/or materials used in the platelet-rich plasma (PRP) preparation process.
- •Patients who are proficient in Indonesian and willing to provide written informed consent.
排除标准
- •Participants who are unable to speak or understand Indonesian and/or are unwilling to provide written informed consent.
- •Patients presenting with types of hair loss other than androgenetic alopecia.
- •Patients currently undergoing therapy with 5-alpha reductase inhibitors.
- •Patients who have received intradermal corticosteroid injections to the scalp within at least 6 months prior to the study.
- •Patients with active infections and/or active dermatitis on the scalp.
- •Patients with a known history of allergy to secretome components and/or materials used in the platelet-rich plasma (PRP) preparation process.
- •History of hypertrophic scarring or blood clotting (coagulation) disorders.
- •Patients unable to complete the research procedures in their entirety.
研究组 & 干预措施
UC-MSC Secretome
Umbilical Cord Mesenchymal Stem Cell-derived Secretome
干预措施: Secretome (Biological)
Platelet-Rich Plasma
Platelet-Rich Plasma
干预措施: Platelet-Rich Plasma (PRP) Injections (Biological)
结局指标
主要结局
Terminal-to-Vellus Hair Ratio
时间窗: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)
The ratio of terminal hair (thick, pigmented hair, diameter \>40 micrometer) to vellus hair (fine hair, diameter \<30 micrometer) in areas of androgenetic alopecia
Hair density
时间窗: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)
The number of hairs per specific scalp area was measured in hairs/cm²
次要结局
未报告次要终点