Oral tranexamic acid in the treatment of moderate to severe melasma.
Not Applicable
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2019/07/020340
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Female and male patients aged more than 18 years with moderate to severe melasma (Moderate melasma will be defined as melasma patients with mMASI score of 5.8 to 7.9 and severe melasma as those with mMASI >= 8 based on defined ranges for melasma severity.46
Exclusion Criteria
1.Known drug hypersensitivity to TXA.
2.Patients on medications for cardiovascular, gastrointestinal, hepatic, renal, disorders.
3.Pregnant or lactating mothers
4.Patients having history of hypercoagulable disorders or history of thrombotic episodes like deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis.
5.Patients taking oral contraceptive pills.
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The primary objective is to evaluate and compare the efficacy of two different dosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, using the mMASI score. The proportion of patients achieving mMASI 75 assesses the efficacy. <br/ ><br> <br/ ><br>Timepoint: Baseline, monthly for 6 months.
- Secondary Outcome Measures
Name Time Method 1.Proportion of patients achieving mMASI 90 <br/ ><br>2.To assess the dose of TXA that acts faster (time to achieve mMASI 75) and prevents relapse while on maintenance therapy. <br/ ><br>3.Change in MELASQOL index over the six month study period. <br/ ><br>4.Duration of treatment <br/ ><br>5.Adverse events, if any, due to TXA <br/ ><br> <br/ ><br>Timepoint: baseline, 3 months, 6 months