Effectiveness and Safety of Topical Finasteride and Minoxidil Combination Compared to Topical Minoxidil for The Treatment of Male Androgenetic Alopecia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Side effects
研究概览
简要总结
A double-blind, randomized, controlled trial of 40 male patients with androgenetic alopecia was conducted. All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical
详细描述
All subject were randomized to receive either combination of minoxidil 5% topical and finasteride 0,1% topical or minoxidil 5% topical The primary outcome was increase of the hair density and hair diameter (mean thickness) measured by trichoscan Measurements were done at baseline and every four weeks for twelve weeks. Additionally, side effects of therapy was also measured.
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 (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor) The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, outcomes assessor, and subjects.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged from 18-59 years diagnosed with androgenic alopecia
- •Androgenic alopecia type III-V according to Hamilton-Norwood criteria
- •Willing to participate in this research by signing the consent form after receiving an explanation from the researcher
- •Willing to not cutting the hair nor coloring the hair during the study
排除标准
- •Diagnosed with other infectious or inflammatory skin disease in the scalp
- •Using oral medications or vitamins that aim to increase the amount of hair in the last 1 month
- •Using topical medication that aim to increase the amount of hair in the last 2 weeks
- •Undergoing cosmetic procedure for AGA therapy such as low-level laser therapy (LLLT) procedures, platelet-rich plasma (PRP) injections, or microneedling within the last 3 months
- •Have sexual disorder such as decreased libido
- •Have a history of allergy or irritant contact dermatitis to the minoxidil and finasteride
研究组 & 干预措施
Combination of minoxidil 5% topical and finasteride 0,1% topical group
Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically
干预措施: Finasteride (Drug)
Combination of minoxidil 5% topical and finasteride 0,1% topical group
Combination of minoxidil 5% solutio and finasteride 0,1% solutio which has administered topically
干预措施: Minoxidil (Drug)
Minoxidil 5% topical group
Minoxidil 5% solutio which has administered topically
干预措施: Minoxidil (Drug)
结局指标
主要结局
Side effects
时间窗: 4 times of measurement in 3 months
Incidence of side effects
Hair density
时间窗: 4 times of measurement in 3 months
Density of the hair is the number of hair strands per square inch of the scalp measured by trichoscan
Hair diameter (mean thickness)
时间窗: 4 times of measurement in 3 months
Hair diameter is the midline of the hair shaft measured by trichoscan
次要结局
- Terminal hair percentage (hair rate terminal)(4 times of measurement in 3 months)
- Dermoscopy(4 times of measurement in 3 months)
- Velus hair percentage ( hair rate vellus)(4 times of measurement in 3 months)
研究者
Farah Faulin Al Fauz Lubis
MD
Indonesia University