Split face study comparing efficacy of microneedling with tranexamic acid versus microinjections with tranexamic acid in melasma in Indian skin
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare the clinical response by mMASI and PtGA score
研究概览
简要总结
After applying inclusion and exclusion criteria .History and written consent from the patient is taken For Group A Patients Topical anesthesia will be applied over lesions under occlusion for 45 minutes Microneedling will be done with DermaPen using the lowest speed with the penetration depth of the needle from 0.25 to 1 mm This will be followed by application of about 0.5 ml TXA (4mg/mL) to the melasma area After cleaning with betadine topical fusidic acid applied under occlusive dressing for the same day All patients will be advised to use sunscreens regurarly The procedure will be repeated every 2 weeks for a maximum of 6 sessions For Group B Patients Topical anesthesia will be applied over lesions under occlusion for 45 minutes Intradermal microinjection of about 4 mg/mL Tranexamic acid will be given in 1 mL insulin syringe with 30 gauge needle Keeping a distance of around 1 cm from each injection with a maximum of 8 mg in a single sitting After cleaning with betadine topical fusidic acid applied under occlusive dressing for the same day All patients will be advised to use sunscreens regularly The procedure will be repeated every 2 weeks for a maximum of 6 session Clinical improvement and side effects will be assessed after each session and at the end of 6 months The study will be concluded with the comparison of clinical improvement of both group A and group B study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 with clinical diagnosis of melasma Patients who are willing to participate in the study.
排除标准
- •Patients allergic to Tranaxemic acid Patients with predisposition to keloids Pregnant and lactating mothers Patients with history of bleeding disorders use of oral anticoagulant drugs Patients under oral contraceptive pills hormonal replacement therapy at the time of or during the past 12 months of study Patients with a history of treatment for melasma in the past 6 weeks in any form.
结局指标
主要结局
Compare the clinical response by mMASI and PtGA score
时间窗: every 2 weeks for 3 months, and at the end of 6 months
to microneedling with tranexamic acid
时间窗: every 2 weeks for 3 months, and at the end of 6 months
and microinjections with tranexamic acid in treatment of melasma
时间窗: every 2 weeks for 3 months, and at the end of 6 months
次要结局
- Treatment side effects(Every 4 weeks for 3 months and at the end of 6 months)
研究者
Dr V JAYAMALIGA
VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKA
