A compare the efficacy of oral tranexamic acid versus intralesional tranexamic acid in management of melasma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- reduction in mMASI score
研究概览
简要总结
Melasma is a common pigmentary disorder. Tranexamic acid is a newer treatment modality and it can be used by various routes such as oral, topical and intradermal. Though oral route is effective, it is associated with various side effects and contraindications. Intradermal tranexamic acid is a new treatment modality owing to its fewer side effects. Thus, we plan to conduct a randomized, controlled trial in order to evaluate the safety and efficacy of intradermal injection of tranexamic acid and compare the results with oral tranexamic acid.
Injection tranexamic acid is available as 500 mg/5 ml ampoule. It is diluted with normal saline to obtain a concentration of 25 mg/ml. In first arm, Intradermal injection of tranexamic acid will be injected 0.1 ml/cm2into the melasma lesions. 3 injections will begiven intradermally at an interval of 4 weeks. In second arm, oral tranexamic acid 250 mg twice a day will be given for 12 weeks.
Clinical, dermoscopic and photographic assessment will be done at 4, 8, 12 and 24 weeks completion of treatment. The severity of melasma will be assessed by Modified MASI scoring at presentation and at completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18-60 years with clinical diagnosis of melasma.
排除标准
- •History of bleeding disorders
- •Patient taking oral anticoagulants, hormonal drugs like estrogen, progesterone, oral contraceptive pills and other female hormonal analogues.
- •Past or family history of thrombotic disease like DVT.
- •Patients with known allergy to tranexamic acid.
- •Pregnant and lactation mothers.
- •Patients with any other facial dermatoses.
- •History of any treatment for melasma in the past 6 months.
结局指标
主要结局
reduction in mMASI score
时间窗: At presentation and follow-up at 4, 8 , 12 and 24 weeks
次要结局
- patient satisfaction score(at presentation and 6 months after treatment)