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Oral tranexamic acid in the treatment of moderate to severe melasma.

A randomized, open label study of two different dosage regimens of oral tranexamic acid in the treatment of moderate to severe melasma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020340
Enrollment
50
Registered
2019-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: Oral tranexemic acid: Oral tranexemic acid 250 mg twice a day for 3 months Control Intervention1: Oral tranexemic acid: Oral tranexemic acid 500 mg twice a day for 3 months

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

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

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. â??

Design outcomes

Primary

MeasureTime frame
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. Timepoint: Baseline, monthly for 6 months.—

Secondary

MeasureTime frame
1. Proportion of patients achieving mMASI 90 2. To assess the dose of TXA that acts faster (time to achieve mMASI 75) and prevents relapse while on maintenance therapy. 3. Change in MELASQOL index over the six month study period. 4. Duration of treatment 5. Adverse events, if any, due to TXA Timepoint: baseline, 3 months, 6 months—

Countries

India

Contacts

Public ContactMuthu Sendhil Kumaran

PGIMER Chandigarh

drsen_2000@yahoo.com8872004023

Outcome results

None listed

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