CTRI/2023/05/052909尚未招募Unknown
A randomised three-armed comparative trial to study the efficacy of low dose oral minoxidil 2.5mg once daily versus 5% topical minoxidil twice daily versus 5% topical minoxidil twice daily +PRP combination in patients with androgenetic alopecia
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- Self
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients showing improvement in modified Norwood-Hamilton scale by 1 grade in each group at end of 24 weeks
研究概览
简要总结
A randomised comparitive three-armed trial to study the efficacy of low dose oral minoxidil 2.5mg once daily versus 5% topical minoxidil twice daily versus 5% topical minoxidil twice daily and PRP combination in androgenetic alopecia. Patient followed up for 6 months, where improvement assessed using clinical photographs and videodermoscope. 5 patients of each group will be randomly selected for biopsy to study the nature of Treg cells and its signalling pathways post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •All androgenetic alopecia patients from Norwood Hamilton grade 3-5 are recruited.
排除标准
- •Patients suffering from other hair disorders, hypotensive episodes, irritant dermatitis to minoxidil, keloidal tendency and bleeding disorders.
结局指标
主要结局
Proportion of patients showing improvement in modified Norwood-Hamilton scale by 1 grade in each group at end of 24 weeks
时间窗: assessed at baseline, 4th month, 6th month
次要结局
- Videodermoscopic assessment as proportion of patients showing 25% increase in hair density 25% decrease in hair diameter diversity and 25% decrease in number of vellus hair/mm2 by end of 24 weeks. Change in population of natural (CD25 high) and induced (CD25 low) T reg cells using Fluorescent activated cell sorting change in NOTCH pathway jagged 1 SOX 9 expression in hair follicle using immunofluorescence pre and post treatment(assessment done at baseline, 16 weeks and 24 weeks)
研究者
研究点 (1)
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