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临床试验/CTRI/2018/07/014952
CTRI/2018/07/014952尚未招募4 期

Effectiveness of Tranexamic acid in the treatment of Melasma - A randomized controlled clinical trial.

Hindu Mission Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月23日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
MASI Score

研究概览

简要总结

Melasma is a common pigment disorder that manifests as symmetric hyper-pigmented macules  on the face mostly on the malar areas of cheek and on forehead and chin and most commonly occurs in women of darker skin color.It typically affects women of reproductive age with skin type IV-VI . Current treatments using topical steroids such as superficial peels Lactic acid glycolic acid , trichlor acetic acid, kojic acid, Lasers and retinoids, demonstrate variable efficacy and side-effect profiles. Despite the plethora of treatment , melasma poses a great challenge as its treatment can be often unsatisfactory with high recurrence rate . The pathogenesis of melasma remains poorly understood and its treatment continues to be challenging with approximately 10% cases occurring in men. The disease prevalence among Asians is about 40% in females and about 20% in males. Melasma is the most common pigmentary disorder in India, with incidence of approximately 10%. It is also found to occur at a younger age among Indians.

Newer formulation that are being tried include tranexamic acid (TA), a well-known Anti-fibrinolytic agent, in the treatment of melasma, which is a plasmin inhibitor used to prevent abnormal fibrinolysis to reduce blood loss. Tranexamic acid is a pro-coagulant agent that is approved by the US Food and Drug Administration for treatment of Menorrhagia and to prevent hemorrhage, it also mitigates the UV radiation-induced pigmentation response. Challenges to the use of tranexamic acid for melasma treatment in a medico-legal environment, specifically the risks associated with using a pro-coagulant medication for a cosmetic indication. Melanocytes cultured in media were found to have decreased tyrosinase activity and reduced melanin content when treated with tranexamic acid.

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 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with diagnosis of melasma . 2.Age
  • 55 years, of either gender. 3.Absence of other confounding inflammatory dermatoses (eg. Exogenous ochronosis, Acanthosis nigricans, post inflammatory hyperpigmentation, Pigmented cosmetic dermatitis, Actinic lichen planus, malar rash, etc.) 4.Willing to follow the study procedures and give written informed consent.

排除标准

  • 1.Pregnancy and lactation.
  • 2.Any chronic medical illness, 3.History of thrombosis, abnormal bleeding profile, 4.Any medical treatment for melasma within 1 month of entry, 5.Skin resurfacing by dermabrasion, chemical peels, and facial laser within the preceding 9 months, 6.Hypersensitivity to TXA, 7.Abnormal bleeding time, clotting time or platelet count.

结局指标

主要结局

MASI Score

时间窗: 90 days

次要结局

  • Occurrence of adverse effects.(Patients satisfaction will be evaluated by a Visual Analogic Scale)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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