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To assess the efficacy and safety of oral tranexamic acid in the management of melasma refractory to conventional treatments

Efficacy and safety of oral tranexamic acid in the management of refractory melasma: A prospective, interventional study. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077373
Enrollment
36
Registered
2024-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: Oral tranexamic acid: 500mg once daily for 6 months Control Intervention1: Not applicable: Not applicable

Sponsors

Department of Dermatology Institute of Medical Sciences Banaras Hindu University Varanasi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and female patient in the age group of 20-50 years with facial melasma for atleast past 3 months and dissatisfied with the results. 2. Interest to participate in research. 3. Normal hemogram, liver function test, renal function test and coagulation profile

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women. 2. History of bleeding disorders. 3. History of deep vein thrombosis or pulmonary embolism. 4. Use of oral anticoagulant drugs. 5. Use of photosensitizing drugs such as non steroidal anti-inflammatory drugs, tetracycline, spironolactone, phenytoin, carbamazepine. 6. Use of oral contraceptive pills or hormone replacement therapy. 7. Known allergy to tranexamic acid. 8. Unrealistic expectations

Design outcomes

Primary

MeasureTime frame
Reduction in mMASI scoreTimepoint: Reduction in mMASI score monthly for 6 months and for 3 months after stopping treatment.

Secondary

MeasureTime frame
To assess any side effects during the course of treatmentTimepoint: Monthly assessment of any side effects if any will be done.

Countries

India

Contacts

Public ContactAnkit Raj

Institute of Medical Sciences, B.H.U., VARANASI

raitulika1323@gmail.com9161023651

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026