Evaluation of Safety and Efficacy of Autologous Stromal Vascular Fraction Derived From Denovo Versus Platelet Rich Plasma Enhanced Donner Site in Treatment of Male Androgenic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- hair shaft thickness
研究概览
简要总结
Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia
详细描述
40 Patients with androgenic alopecia will be randomly divided into 2 groups Group A (20): will receive 2 session of stromal vascular fraction directly after fat harvesting and processing and stromal vascular fraction extraction with 1 month interval .
Group B(20): will be injected with 2 session of Platelet rich plasma 3weeks interval at site of fat harvesting and will be followed 1 month later with fat aspiration from site where Platelet rich plasma was previously injected and this fat will undergo fat processing and stromal vascular fraction extraction followed by 2 session of stromal vascular fraction injection at scalp 1month interval .
Patients at both groups will receive topical and systemic antibiotics after stromal vascular fraction injection .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients with androgenic alopecia
排除标准
- •Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
- •Any other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.
- •Any systemic disease as autoimmune disorders , cardiac hepatic and renal patients.
- •patients who received minoxidil or any other oral, topical medications (including herbal medications) or injection procedures for the treatment of hair loss within 6 months prior to the study, or finasteride or dutasteride within 12 months of the study
结局指标
主要结局
hair shaft thickness
时间窗: at baseline and at 6 month after treatment
TrichoScan
hair density
时间窗: at baseline and at 6 month after treatment
Trichoscopy
次要结局
未报告次要终点
研究者
Dina Ahmed Mahmoud
assistant lecturer
Sohag University