Comparison Of efficacy Of oral minoxidil 1.25mg vs topical minoxidil 5% in male androgenetic alopecia -a randomised open label pilot study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Clinical photographic assessment and quantitative
研究概览
简要总结
Low dose oral Minoxidil 0.25-5mg/day has been used off label to treat various forms of Alopecia.Oral Minoxidil has ; many patients find oral administration more convenient than topical application of a lotion or foam,
topical application is operator dependent i.e some parts of the scalp may be missed in those with widespread alopecia, and low dose oral minoxidil circumvents the local side effects associated with topical minoxidil such as irritation and allergic contact dermatitis.
One group shall be treated with oral minoxidil
1.25mg for 24 weeks
- Second group shall be treated with topical
minoxidil 5% for 24 weeks.
Outcome-
1.Clinical photographic assessment and quantitative
assessment using densitometer will be done.
2.Hair density calculation will be done in a square inch
area from a point formed by intersection of lines joining
glabella and occiput and joining the parietal prominences.
3.The number of vellus hairs, terminal hairs will be
counted in the specific square inch area.
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).
排除标准
- •1.Severe hypertension, moderate hypertension on antihypertensive therapy 2.Cardiovascular dysfunction 3.History of minoxidil hypersensitivity 4.On treatment with formulation of minoxidil, DHT- blockers or other treatments for AGA in the past 3 months.
- •5.Psychiatric or scalp disease.
结局指标
主要结局
1.Clinical photographic assessment and quantitative
时间窗: every monthly for 6 months
assessment using densitometer will be done.
时间窗: every monthly for 6 months
2.Hair density calculation will be done in a square inch
时间窗: every monthly for 6 months
area
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