The efficacy and safety of injectable platelet rich fibrin (PRF) therapy and topical minoxidil (5%) fortified with finasteride (0.1%) in the treatment of androgenetic alopecia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Efficacy and safety of injectable platelet rich fibrin therapy and topical minoxidil(5%) fortified with finasteride(0.1%) in the treatment of androgenetic alopecia
研究概览
简要总结
Androgenetic Alopecia is a nonscarring alopeciathat affects both men and women. The onset of Androgenetic Alopeciais usually gradual and the condition slowly develops over the years**.** It is characterized by a progressiveminiaturization of hair follicles with a characteristic pattern distribution ingenetically predisposed men and women. Is the most frequent type of hair lossin both sexes. AlthoughAndrogenetic Alopecia is more frequent in adults, it can also appear inadolescents , though its prevalence among this younger population is not wellestablished. Treatments includepharmacotherapy, surgery, and cosmetic aids. Despite the demand, there are onlytwo FDA-approved medications to treat Androgenetic Alopecia: the potassiumchannel opener Minoxidil, and the DHT synthesis inhibitor Finasteride, botheffective at controlling AGA with long-term daily use. However, they arecostly, require lifelong treatment and may have side effects. Medical therapyis most effective when started in the early phases of hair loss and patientsmay elect to be treated non-surgically only. Undoubtedly, medical therapy willplay a central role as an adjunct to surgical treatment by preventing the lossof surrounding native hair and thus enhancing the overall esthetic result. PRF is actually a newplatelet concentrate concept which accumulates platelets and the releasedcytokines in a fibrin clot. Advanced-PRF (A-PRF) and Injectable-PRF (i-PRF), onthe other hand, are different from conventional PRF and is based on the conceptthat low speed of centrifugation, yields maximum results and significantlyhigher number of leukocytes, platelets, and growth factorconcentration-enhancing the regeneration process. This study aims to compare the efficacy and safety of intradermal platelet rich plasma (PRF) therapy and topical minoxidil (5%) fortified with finasteride (0.1%) in the treatment of androgenetic alopecia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age group 18-50 years Presenting with patterned hair loss Males.
- •norwood hamilton grade 3,4,5 Patients who have not taken medical treatment for aga in any form for the last 6 months.
排除标准
- •Patients with alopecia other than androgenetic alopecia Patient with active infection at the local site Patient have keloidal tendency Patient with blood coagulopathies Platelet count less than 1.5 lac/ul Patients who are immunocompromised(hiv, malignancy, steroid or chemotherapy).
结局指标
主要结局
Efficacy and safety of injectable platelet rich fibrin therapy and topical minoxidil(5%) fortified with finasteride(0.1%) in the treatment of androgenetic alopecia
时间窗: 52 weeks
次要结局
- reported adverse events of the procedure in both intervention & comparator agent(52 weeks)