Minoxidil in Treatment of Androgenetic Alopecia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Ludwig scale grading system
研究概览
简要总结
The study will be included 60 women with FPHL. The diagnosis of FPHL will be established by clinical (Ludwig classification) and trichoscopic evaluation of frontal and occipital regions of the scalp.
详细描述
Enrolled women will be randomly assigned into 3 treatment groups: group A will apply topical minoxidil 5% in 90% ethanol and 5% propylene glycol, group B will apply topical minoxidil 5% in pure ethanol alone and group C will apply pure ethanol (placebo) twice daily.
The treatment will be continued for six months with regular visits at 3 months intervals.
The medications will be provided in bottles which were identical in shape and color, and were coded by a third party.
Both patients and investigator will be blinded to the medication. Disclosure of the codes will be done, by a third party, at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The medications will be provided in bottles which will be identical in shape and color, and will be coded by a third party. Both patients and investigator will be blinded to the medication. Disclosure of the codes will be done, by a third party, at the end of the study.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol
干预措施: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol (Drug)
Topical minoxidil 5% in pure ethanol alone
Group B applied topical minoxidil 5% in pure ethanol alone
干预措施: Topical minoxidil 5% in pure ethanol alone (Drug)
Placebo
Group C applied pure ethanol (placebo)
干预措施: Placebo (Ethanol) (Other)
结局指标
主要结局
Ludwig scale grading system
时间窗: 0-6 months
The 3 grades will be defined. Grade 1, (Thinning of hair is seen mainly over the anterior part of the crown with minimal widening of the parting width). Grade 2, (Thinning of the crown becomes more evident because of an increase in the number of thin and short hairs). Grade 3, (The crown becomes almost total bald, but the frontal hair line is still maintained).
Trichoscopic examination of the hairs at frontal and occipital regions of the scalp.
时间窗: 0-6 months
It will be evaluated signs of hair changes such as hair diameter diversity.
次要结局
未报告次要终点
研究者
Mohammed Abu El-Hamd
Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.
Sohag University