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a study to compare two treatment options for melasma.

A double arm RCT comparing the efficacy of intralesional Tranexamic acid with standard topical kligmanâ??s regimen in patients with facial melasma.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014062
Enrollment
60
Registered
2018-05-23
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: null- facial melasma

Interventions

Intervention1: Injection Tranexamic acid: Intradermal injections of Tranexamic acid 4 mg/mL. Injections of about 0.05mL at 1 cm interval every 2 weeks for 12 weeks or till complete clearance. Control

Sponsors

Pawan Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consenting male and female patients diagnosed clinically with melasma

Exclusion criteria

Exclusion criteria: a) Pregnancy, lactation and females taking HRT/OCPâ??s b) Any severe chronic medical illness, c) Bleeding disorders or concomitant use of anticoagulants d) Any medical treatment for melasma within 1 month of entry, e) Hypersensitivity to TXA f) Abnormal bleeding time, clotting time or platelet count g) Refusal to allow photographs and Failure to finish the whole period of study would be excluded from the study.

Design outcomes

Primary

MeasureTime frame
improvement in modified melasma area and severity index (mMASI).Timepoint: 4 weeks, 8 weeks and 12 weeks

Secondary

MeasureTime frame
physicianâ??s global assessment and patient global assessment scales, and safety assessmentTimepoint: 12 weeks

Countries

India

Contacts

Public ContactPawan Gupta

K.J Somaiya medical college and research center

spoojary2004@gmail.com9820601511

Outcome results

None listed

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