A Comparative Study between Oral Administration of 2.5 mg Minoxidil and Topical Application of 5 percent Minoxidil in Conjunction with Autologous Platelet-Rich Plasma for the Treatment of Male Androgenetic Alopecia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To measure the hair shaft diameter and Hair density in both groups ,will be assessed at baseline and every 4 weekly using Tricoscopy.
研究概览
简要总结
Background
Androgenetic alopecia is a prevalent , non scarring form of progressive hair loss in men, affecting upto 80% by age 70 . FDA approved treatments , including topical minoxidil and oral finasteride are limited by suboptimal efficacy , side effects and poor compliance . Low dose oral minoxidil and autologous PRP therapy have recently emerged as promising alternative.
Objective
To compare the efficacy , safety and early response rates of oral minoxidil 2.5 mg with PRP versus topical 5 % minoxidil with PRP in male AGA patients.
Methodology
A prospective, randomised , comparative , interventional study will be conducted over a span of two years at AVBRH Wardha , involving 50 male patients via Hamilton norwood grading of II to V , divided equally in two groups . Group A will receive oral minoxidil 2.5 mg daily along with monthly PRP, while Group B will receive topical 5 % minoxidil twice daily along with monthly PRP. Efficacy will be assessed at baselines and 4 weeks interval over 12 weeks via trichoscopy, clinical photographs and patient satisfaction using a 5 point likert scale .
Conclusion
This study aims to generate comparative data on oral versus topical minoxidil in conjunction with PRP and to identify early therapeutic responders for more personalised and effective AGA mangement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male patients aged 18 to 50 years 2.Clinically diagnosed of patients of AGA classified according to Hamilton Norwood stage II to V 3.No treatment taken for hair loss topical, oral or procedural in the past 1 month.
- •4.Willing to provide informed consent to comply with all aspects of the study protocol.
排除标准
- •1.Patients with scarring alopecia or other forms of hair loss e.g. alopecia areata, telogen effluvium.
- •2.Patients who are a known case of Coagulopathies or on anticoagulant,antiplatelet therapies.
- •3.Active scalp infections or any scalp dermatoses.
- •4.Use of immunosuppressive or hormonal therapies.
- •5.Severe co morbidities like Cardiovascular or endocrine disorders ,uncontrolled diabetes, renal or hepatic disorders.
- •6.Known hypersensitivity to minoxidil or PRP constituents.
- •7.Seropositivity for HIV, Hepatitis B, or Hepatitis C.
结局指标
主要结局
To measure the hair shaft diameter and Hair density in both groups ,will be assessed at baseline and every 4 weekly using Tricoscopy.
时间窗: Assessment will be done in 4 months.
次要结局
- To assess the patient satisfaction by using a standardized 5 point Likert scale .(Assessment will be done in 4 months.)
研究者
Lamiya Latheef Rawther
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research