CTRI/2024/11/077373尚未招募2 期
Efficacy and safety of oral tranexamic acid in the management of refractory melasma: A prospective, interventional study.
Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年12月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in mMASI score
研究概览
简要总结
Patients aged 20-50 years diagnosed clinically with melasma and fulfilling the inclusion criteria will be included in the study.
Oral tranexamic acid 500mg will be given once daily for a duration of 6 months.
mMASI ( modified Melasma Area and Severity index )score will be assessed monthly during the treatment period of 6 months and for 3 months after stopping of treatment.
Side effects if any will be assessed during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patient in the age group of 20-50 years with facial melasma for atleast past 3 months and dissatisfied with the results.
- •Interest to participate in research.
- •Normal hemogram, liver function test, renal function test and coagulation profile.
排除标准
- •Pregnant and lactating women.
- •History of bleeding disorders.
- •History of deep vein thrombosis or pulmonary embolism.
- •Use of oral anticoagulant drugs.
- •Use of photosensitizing drugs such as non steroidal anti-inflammatory drugs, tetracycline, spironolactone, phenytoin, carbamazepine.
- •Use of oral contraceptive pills or hormone replacement therapy.
- •Known allergy to tranexamic acid.
- •Unrealistic expectations.
结局指标
主要结局
Reduction in mMASI score
时间窗: Reduction in mMASI score monthly for 6 months and for 3 months after stopping treatment.
次要结局
- To assess any side effects during the course of treatment(Monthly assessment of any side effects if any will be done.)
研究者
Dr Tulika Rai
Institute of Medical Sciences, B.H.U., VARANASI
研究点 (1)
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