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临床试验/CTRI/2024/01/061416
CTRI/2024/01/061416尚未招募不适用

COMPARATIVE STUDY OF TRANEXAMIC ACID MESOTHERAPY VERSUS TOPICAL TRANEXAMIC ACID IN PATIENTS WITH MELASMA

Dr Yash Kashikar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction of Melasma Assesment & Severity Index score (MASI) by Tranexamic acid mesotherapy in comparison to topical application

研究概览

简要总结

In recent years,off-label Tranexamic acid (TA) has emerged as a potential treatment for melasma. Although themechanism of action remains unclear, it is thought that TA may inhibit melaninsynthesis by blocking the interaction between melanocytes and keratinocytes. TAmay also reverse the abnormal dermal changes associated with melasma, such asthe aforementioned increased vasculature. While different forms of TA (i.e.oral, topical, and localized microinjections) have shown promising results.

However, till date, thereis no consensus on the optimum route, dose, and timing of the treatment with TAin melasma. It has been tried both orally and topically. When used along withmicro-needling, the frequency of the treatment depends on the size of the derma-rollerused that is, the needle size. Hence the present study is needed tocomparatively evaluate the effect of topical versus mesotherapy usingTranexamic acid. Moreover, the novel mesotherapy device used in the study whichuses cryo electroporation technology without using needles could provide a newapproach to conventional microneedling.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • A clinical diagnosis of melasma between the ages of 18 to 65 years.

排除标准

  • Patients suffering from significant systemic illness and on certain drugs such as anticoagulants, oral contraceptive pills, hormone replacement therapy, NSAIDs, antiepileptic medications, isotretinoin, or any other phototoxic medication, with known hypersensitivity to Tranexamic acid Pre-existing facial dermatoses Past history of thrombotic disease such as deep vein thrombosis Pregnancy and lactation.

结局指标

主要结局

Reduction of Melasma Assesment & Severity Index score (MASI) by Tranexamic acid mesotherapy in comparison to topical application

时间窗: Baseline, 4 weeks

次要结局

  • Reduction of MASI score by Tranexamic acid mesotherapy in comparison to topical application(8 weeks)

研究者

发起方
Dr Yash Kashikar
申办方类型
Other [Principle investigator]

研究点 (1)

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