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临床试验/CTRI/2018/05/014262
CTRI/2018/05/014262已完成不适用

Study of the safety and efficacy of topical minoxidil(5%) versus Minoxidil(5%) and Finasteride (0.1%) combination in the treatment of androgenetic alopecia in men

Dr Alex James1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Increase in hair growth

研究概览

简要总结

Androgenetic alopecia is a genetically determined pattern of baldness. it causes an alteration in hair cycle dynamics that is characterised by stepwise miniaturisation of the hair follicle. This leads to vellus transformation of the terminal hair follicles. Genetic factors and androgens both play a key role in causing androgenetic hair loss. Several studies have been conducted testing the benefits of topical minoxidil and oral finasteride for the treatment of androgenetic alopecia. However, studies to prove the benefits of its combination are few in number. Hence this comparative study is undertaken. objective of the study is to compare the safety and efficacy of topical minoxidil(5%) and minoxidil(5%) +finasteride (0.1%) combination adult male patients with androgenetic alopecia and determine the various clinical patterns of androgenetic alopecia. 40 patients are enrolled in the study in which 20 patient will be treated with minoxidil(5%)(GROUP A) and other 20 will be treated with Minoxidil(5%) +Finasteride (0.1%) combination(GROUP B). Both the group will be instructed to apply 1 ml topically over the scalp. Follow up will be done every month for 4 months. Dermoscopic images of the scalp will be taken at initial visit, 8th week and 16th week. Patient will be assessed for hair growth using 5 point scale grade 1(Markedly improved), grade 2 (Moderately improved), grade 3 (slightly improved), grade 4 (unchanged), grade 5 (worsened). patient were assessed for any adverse effects of therapy at each visit.Data will be collected and analysed by frequency, percentage, Mean, standard deviation and chi-square test.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Male

入选标准

  • •1.Male patients between 18-45 years.
  • •2.Patients with grade II –IV of modified Norwood Hamilton classification of AGA.
  • •3.Men willing to use the same shampoo and maintain same hair length and colour for the entire duration of the study.

排除标准

  • •1.Patients who are not willing for the study.
  • •2.Patients with dermatological disorders on the scalp other than AGA.
  • •3.Patients with serious cardiovascular, renal or hepatic disease.
  • •4.Patients with history of drug hypersensitivity.
  • •5.Patients who are using any other therapy for AGA.

结局指标

主要结局

Increase in hair growth

时间窗: Increase in hair growth after and growth will be assessed at initial visit, 8th week and 16th week

次要结局

  • itching, erythema and dandruff.(To be assessed at initial visit, 8th week and 16th week)

研究者

发起方
Dr Alex James
申办方类型
Other [self]

研究点 (1)

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