Comparative study to know the efficacy and safety of stromal vascular fraction-enriched platelet-rich plasma therapy versus platelet rich plasma therapy in the treatment of Androgenetic alopecia
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hair growth is the primary outcome the improvement will be assessed using pre†and post†treatment photographs, Physicians global assessment (PhGAS) scores, Patients global assessment score(PaGAS) and trichoscan.
研究概览
简要总结
It’s a“Comparative interventional study†To compare the efficacy and side effects of stromal vascular fractionâ€enriched platelet†rich plasma therapy versus platelet rich plasma therapy in the treatment of Androgentic Alopecia . Androgenetic alopecia is characterized by progressive patterned hair loss. AGA is hereditary and the circulating androgen hormones may cause the conversion of terminal hair to vellus by miniaturization of hairfollicles. In the treatment of androgenetic alopecia, currently minoxidil and oral finasteride, are the only two therapeutic drugs approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). They must be used lifelong and daily, as its interruption is followed by gradual return of hair loss. They may have limited degree of improvement in some patients.
Platelet rich plasma(PRP) has a good potential in treatment of AGA and has gained popularity since last decade. PRP contains many growth factors that can activate the proliferative phase of hair bulge area of the follicles
Adipose tissue derived stromal vascular fraction(SVF), is an emerging treatment for AGA. It contains non cultured regenerative cells -mesenchymal cells or adipose cells that can “home†to the site of injury. The restoration of hair with PRP in AGA can be augmented by enriching PRP with SVF.
In our study we want to know if enriching PRP with SVF gives better hair restoration in AGA as compared with PRP alone.
Each patient will undergo two sessions at an interval of 4 weeks. They will be followed up monthly for 2 months till the last session. After PRP and SVFâ€PRP therapy, the improvement will be assessed using pre†and post†treatment photographs, Physicians global assessment (PhGAS) scores, Patients global assessment score(PaGAS), Alopecia quality of life assessment and trichoscan after every session. Alopecia quality of life assessment will be assessed by using dermatology life quality index(DLQI). DLQI will be performed before the start of treatment and at the end of follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 96.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Hamilton score 2-6 in male patients,ludwing score 1-3 in female patients 2.patients not on any treatment for androgenetic alopecia for past 1 month.
排除标准
- •1 Patient with malignancy, autoimmune disease 2 Pregnancy 3 History of keloid formation 4 Patients with platelet disorders, thrombocytopenia, sepsis.
- •5 Patients currently on anticoagulant therapy, 6 Patients on chemotherapy during the last 5years.
结局指标
主要结局
Hair growth is the primary outcome the improvement will be assessed using pre†and post†treatment photographs, Physicians global assessment (PhGAS) scores, Patients global assessment score(PaGAS) and trichoscan.
时间窗: 3 weeks
次要结局
- Alopecia quality of life assessment will be assessed by using dermatology life quality index(DLQI).(Baseline,12 weeks & 16 weeks.)
研究者
Dr Leena Raveendra
Rajarajeshwari medical college and hospital
