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临床试验/CTRI/2024/02/063225
CTRI/2024/02/063225尚未招募不适用

Comparison of efficacy of topical 0.025 % Dutasteride plus 5 % Minoxidil solution vs topical Minoxidil 5 % alone in male androgenetic alopecia - a randomised open label pilot study

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1. Clinical photographic assessment and quantitative assessment using densitometer

研究概览

简要总结

The patients meeting all the inclusion criteria and not meeting any exclusion criteria shall be considered to participate in the study. ·       A detailed history including the duration of disease , associated medical conditions , treatment history and family history is to be taken. ·       The patients are randomized according to random  number generator and allocated to two interventional group. ·       Assessor shall be blinded. ·       Two medications shall be given. ·       One group will be given topical dutasteride 0.025% morning time and 5% minoxidil solution at night time for 24 weeks. ·       The other group will be given topical minoxidil  5% twice daily for 24weeks. ·       Follow up is done at baseline and after recruitment into trial every 4weeks for 24weeks. ·       The outcome will be based on photographic assessment  and quantitative assessment using densitometer. ·       Any patient developing side effects  or severe pain  shall be pulled out of intervention. Clinical photographic assessment and quantitative assessment using densitometer will be done every 4 weeks till 24weeks with due care the patients identity is not revealed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

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.All males aged 18-45 yrs of age
  • Males with (Hamilton Norwood Scale II-IV)
  • Who are not currently undergoing any hair treatment and have not undergone any in the last 3 months.

排除标准

  • 1.Severe hypertension, moderate hypertension on antihypertensive therapy.
  • 2.Cardiovascular dysfunction 3.History of minoxidil hypersensitivity 4.Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors 5.Psychiatric or scalp disease.

结局指标

主要结局

1. Clinical photographic assessment and quantitative assessment using densitometer

时间窗: every monthly for 6 months

2. Hair density calculation

时间窗: every monthly for 6 months

次要结局

  • The number of vellus hairs, terminal hairs determined by their thickness in the specific square inch area(every monthly for 6 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Bikash Ranjan Kar

IMS and SUM Hospital

研究点 (1)

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