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
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
Bikash Ranjan Kar
IMS and SUM Hospital
