跳至主要内容
临床试验/CTRI/2024/03/064275
CTRI/2024/03/064275尚未招募2 期

Split face study comparing efficacy of microneedling with tranexamic acid versus microinjections with tranexamic acid in melasma in Indian skin

Vinayaka Missions Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月29日最近更新:

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

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr V JAYAMALIGA

VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKA

研究点 (1)

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