The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.
研究概览
简要总结
The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal females with Androgenetic Alopecia (AGA).
详细描述
Participants diagnosed with AGA will be randomized into one of the two treatment arms outlined below, and will take the assigned treatment for a total duration of 12 months. Medications will be dispensed by a nurse who is blinded to the participants within each treatment group. Global photograph assessment and participant questionnaires at 0, 4, 8 and 12 months will be the primary means to determine improvement in hair loss.
Compare the following interventions in treating postmenopausal female AGA:
A) Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postmenopausal (>60 years old or with total hysterectomy)
- •diagnosed with androgenetic alopecia
- •no chemical processing or changes in hair products throughout the study
排除标准
- •premenopausal women (<60 or without hysterectomy)
- •participants allergic to any of the study medications (minoxidil, finasteride, spironolactone)
- •participants with other co-existing forms of alopecia (traction, alopecia areata, or scarring alopecias)
- •participants with obstructive uropathy or advanced liver disease
- •prior hair loss treatment within the last 6 months
- •hair loss from the chemotherapy or other medication-induced alopecia
- •Hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period.
研究组 & 干预措施
Combination Group
This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
干预措施: 5% Minoxidil (Drug)
Combination Group
This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
干预措施: 200mg Spironolactone (Drug)
Single Group
This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.
干预措施: 5mg Finasteride (Drug)
Single Group
This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.
干预措施: Placebo (Other)
结局指标
主要结局
Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.
时间窗: Change at 0, 4, 8, and 12 months
The value will be one of 7 numbers, ranging from -3 to +3. The values will stand for the following: * 3: markedly worsened alopecia * 2: moderately worsened alopecia * 1: slightly worsened alopecia 0: no change in alopecia * 1: slightly improved alopecia * 2: moderately improved alopecia * 3: markedly improved alopecia
The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups.
时间窗: Change at 0, 4, 8, and 12 months
This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3
The Savin Scale will be used to determine hair growth and/or hair loss between the groups.
时间窗: Change at 0, 4, 8, and 12 months
This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia.
次要结局
未报告次要终点