Efficacy of Topical Minoxidil alone, Topical Finasteride alone and Topical Minoxidil - Finasteride combination in Male Androgenetic Alopecia - A Randomized Open-Label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Mean Physician Assessment score (PAS)
研究概览
简要总结
Androgenetic alopecia (AGA) is the most common cause of hair loss in males and females and is characterized by a patterned hair loss. It can be psychosocially and emotionally very distressing to the patient leading him/her to feel unattractive and less confident. It has been therapeutically challenging to treat this condition. There are very limited atudies which have documented the efficacy of various treatment options. Therefore, this study aims to observe the efficacy of three topical treatment regimens that are routinely offered to patients with AGA presenting to our hospital, so as to identify the most effective treatment regimen available for these patients.
This is an open label randomized controlled trial where patients will be randomized by computer generated variable block size randomization. Patients will be allocated into three groups by sealed opaque envelope technique. Follow up period is 6 months and patients will be assessed at 12 and 24 weeks and the following observations will be made:
-
Mean physician assessment score (PAS)
-
Mean change in hair density
-
Mean change in number of terminal and vellus hair
-
Mean patient satisfaction score (PSS)
-
Proportion of patients experiencing side effects
Data will be collected and compiled in an excel sheet and will be analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Male
入选标准
- •All new male patients with clinically diagnosed androgenetic alopecia of grade III or higher (Modified Norwood Hamilton classification).
排除标准
- •Patients who have used any topical or systemic drugs in the past 6 months to promote hair growth
- •Patients with other scalp diseases that affect hair growth including seborrheic capitis
- •Patients with elevated levels of serum prostate specific antigen (PSA)
- •Patients with thyroid abnormality or vitamin D deficiency
- •Patients with history of continuing intake of following drugs – antihypertensives, antiepileptics, cytotoxic drugs, systemic corticosteroids, bronchodilators and vasodilators.
结局指标
主要结局
1. Mean Physician Assessment score (PAS)
时间窗: 12 and 24 weeks
2. Mean change in hair density from baseline
时间窗: 12 and 24 weeks
Improvement in one or more of the following parameters in the three groups:
时间窗: 12 and 24 weeks
3. Mean change in number of terminal and vellus hair from baseline
时间窗: 12 and 24 weeks
次要结局
- Mean Patient Satisfaction Scores (PSS)(12 and 24 weeks)
- Proportion of patients experiencing side effects in the three groups(12 and 24 weeks)