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临床试验/CTRI/2024/09/073872
CTRI/2024/09/073872尚未招募不适用

A comparative study of modified kligman regimen versus combination of modified kligman with oral tranexamic acid in the treatment of melasma

Dr Anuradha Gupta1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年9月20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
170
试验地点
1
主要终点
age

研究概览

简要总结

Not yet recruiting .waiting  for ctri registration .Melasma  also known as chloasma is a  hyper pigmentary disorder which commonly affects face. Melasma is one of the most common pigmentary disorder in dermatology clinic. Females are more commonly affected than males in the ratio of 9:1.Exact etiology of this disorder is unknown. However cause is multifactorial and it includes sun exposure ,pregnancy, drugs, harmonal imbalance etc.Excessive sun exposure is the most common cause.Approximately 20 percent of pregnant female develop melasma during pregnancy and hardly regress after pregnancy.

melasma posses cosmetic as well siginificant negative impact on patients quality of life. At present the treatment modalities available are topical agents ,lasers ,chemical peels, microneedling  etc. Procedures are expensive and need follow ups and multiple visits. Hence, There is need to research for an effective therapeutic agent which is cheap ,give a better outcome and without causing major side effects.

Modified kligman regimen is a standard treatment to treat melasma. This regimen take long time to treat melasma .Hence, trenaxemic acid was selected for this study to reduce the  duration of treatment. Trenaxamic acid is an antifibrinolytic which is extensively used to treat menorrhagia. It acts by inhibiting plasminogen activator and interfere with production of melanin, thereby reducing the hyperpigmentation of melasma.

Hence,this study will be done to investigate whether oral trenaxamic acid is add on to standard therapy i.e.modified kligman regimen is effective in the treatment of melasma.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • : 1- Patients aged between 20 to 60yrs.
  • 2- Patients diagnosed with Melasma and not taking oral/topical medication in last 3 months.
  • 3- Patients who give consent for study.

排除标准

  • H/o Thrombotic events, Stroke, Myocardial Infarction.
  • Pregnant women, menstrual irregularities.
  • Patients taking oral contraceptives
  • Patients with sensitive skin (burning sensation, allergic to any topical creams).
  • Photosensitivity disorders (SLE, porphyria, drugs).
  • Underwent any recent surgeries within a period of (3 months) and undergoing any cosmetic procedure.
  • Patients not willing to participate in study.

结局指标

主要结局

age

时间窗: start of therapy

duration

时间窗: start of therapy

gender

时间窗: start of therapy

type of melasma

时间窗: start of therapy

location of melasma

时间窗: start of therapy

size of lesion

时间窗: start of therapy

MSI score

时间窗: start of therapy

次要结局

  • age(duration)

研究者

发起方
Dr Anuradha Gupta
申办方类型
Other [Self funding]
责任方
Principal Investigator
主要研究者

Dr Anuradha Gupta

Peoples college of medical science and research center

研究点 (1)

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