COMPARATIVE EVALUATION OF PLATELET-RICH PLASMA WITH GROWTH FACTOR CONCENTRATE IN THE MANAGEMENT OF ANDROGENIC ALOPECIA – A RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 2. Hair density with the help of trichoscope
研究概览
简要总结
Androgenic alopecia (AGA) is a progressive, nonscarring hair loss condition affecting up to 80% of men and 40% of women, with noticeable patterns and genetic predisposition. While FDA-approved treatments like minoxidil and finasteride are available, their limited efficacy and side effects prompt the need for alternative therapies. Platelet-rich plasma (PRP) therapy, rich in growth factors such as PDGF, VEGF, TGF, and IGF, has shown potential in stimulating hair follicle stem cells. Growth Factor Concentrate (GFC) is a modified PRP technique offering a higher concentration of these growth factors, showing promising results in hair regrowth and follicular regeneration. However, comparative data between PRP and GFC in the Indian population is limited. This randomized controlled trial aims to compare the efficacy of PRP and GFC therapies in managing AGA. The null hypothesis states no difference between the two treatments, while the alternate hypothesis suggests GFC is superior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients between age of 20-65 years of both genders.
- •Type I and Type II Patients indicated for the management of androgenic Alopecia as per Bouhanna’s classification for male and Ludwig’s classification for female
- •Healthy patients falling under ASA I and ASA II
- •Subjects able and willing to provide written informed consent and compliant with study procedure.
排除标准
- •Patients who had not received any topical or systemic treatment for their hair loss during the last 3 months
- •Patient with history of having anticoagulant therapy
- •Patients having history of autoimmune disorder, haematological disorder and platelet dysfunction syndrome.
- •Patients with a history of immunosuppression (malignancy, chemotherapy, steroid therapy), dermatological acute infections and diseases other than androgenic alopecia affecting the scalp.
- •Patient is under regular analgesics and anti-depressants.
- •Having previous history of radiation therapy in the head and neck region.
- •Pregnant and nursing women.
- •Patients with a history of hair transplant.
- •Patient having tendency for the keloid formation.
- •Patient who has already received PRP and GFC treatment for more than 3 sittings within 3 months
- •Patients with the history of immunodeficiency virus (HIV, hepatitis B and hepatitis C).
结局指标
主要结局
2. Hair density with the help of trichoscope
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
3. Patient satisfaction
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
Immediate postoperative:
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
1. Pain on visual analogue scale while injecting PRP or GFC
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
Postoperative:
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
4. Investigator satisfaction
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
Preoperative:
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
1. Hair-pull test
时间窗: Day O and Postoperatively On 1st, 2nd, 3rd and 4th month postoperatively
次要结局
- any other complication(On 1st, 2nd, 3rd and 4th month postoperatively)
