A comparative study of modified kligman regimen versus combination of modified kligman with oral tranexamic acid in the treatment of melasma
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
Dr Anuradha Gupta
Peoples college of medical science and research center
