EFFICACY AND SAFETY OF TOPICAL MINOXIDIL 5 PERCENT ALONE VERSUS ORAL MINOXIDIL VERSUS TOPICAL MINOXIDIL 5 PERCENT WITH ORAL SPIRONOLACTONE IN FEMALE PATTERN HAIR LOSS : A RANDOMISED CLINICAL COMPARATIVE TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This randomized comparative clinical trial evaluates the efficacy and safety of three treatment regimens for Female Pattern Hair Loss (FPHL): topical minoxidil 5% alone, topical minoxidil plus low-dose oral minoxidil, and topical minoxidil plus oral spironolactone. FPHL is a common, progressive condition with limited long-term results from topical minoxidil monotherapy, and evidence for combination therapy—especially dual minoxidil therapy—remains insufficient. After obtaining consent, eligible patients undergo baseline history, Ludwig grading, global assessments, standardized scalp photography, dermoscopic evaluation of a tattoo-marked target area, and baseline ECG, serum potassium, and blood pressure recording. Participants are randomized into three groups and followed at 4, 8, 16, and 24 weeks for repeat dermoscopic measurements, physician and patient global assessments, hair density and shaft diameter evaluation, and safety monitoring. This study aims to determine whether combined topical and oral minoxidil offers superior outcomes, potentially providing a more effective therapeutic option for women with FPHL
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
- Female
入选标准
- •All females aged between 18-45 years with female pattern hair loss; Ludwig scale II- III.
- •Any females who completed 4 months of therapy.
排除标准
- •1.Any relative contraindications to oral spironolactone; such as insufficiency of heart, liver, kidney, low blood pressure or elevated blood potassium levels.
- •2.Any relative contraindications to oral minoxidil; such as any history of bleeding disorders, use of anticoagulants or active infection at the targeted area.
- •3.Use of topical or systemic medications that influence hair growth within the last 6 months 4.Pregnancy and lactation.
- •5.Patients planning to conceive within a year 6.Presence of any other forms of alopecia (alopecia areata, frontal fibrosing alopecia, telogen effluvium).
研究者
Sreya Sibbadi
IMS & SUM Hospital
